Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-28 @ 8:45 PM
Study NCT ID:
NCT01990612
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2013-11-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Trial of Induction Versus Expectant Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'w-grobman@northwestern.edu', 'phone': '312-472-4661', 'title': 'Dr. William Grobman', 'organization': 'Northwestern University'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected and evaluated from the date of randomization (between 38 weeks, 0 days gestation and 38 weeks, 6 days gestation) through approximately 8 weeks postpartum. This time frame encompasses between 9 and 12 weeks.', 'description': 'The primary and secondary outcomes comprise all the adverse events that occurred. We expect this is different than, for example, a medication trial in which adverse events other than those related to the outcomes may occur.', 'eventGroups': [{'id': 'EG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.', 'otherNumAtRisk': 3037, 'deathsNumAtRisk': 3059, 'otherNumAffected': 0, 'seriousNumAtRisk': 3037, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.", 'otherNumAtRisk': 3059, 'deathsNumAtRisk': 3037, 'otherNumAffected': 0, 'seriousNumAtRisk': 3059, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Perinatal Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3037, 'numEvents': 3037, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3059, 'numEvents': 3059, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of Severe Neonatal Morbidity and Perinatal Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.00', 'estimateComment': 'One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \\<0.46 considered stat sig"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through 72 hours after birth', 'description': 'Includes any one of:\n\n* Perinatal death\n* Need for respiratory support within 72 hours after birth\n* Apgar score of 3 or less at 5 minutes\n* Hypoxic-ischemic encephalopathy\n* Seizure\n* Infection (confirmed sepsis or pneumonia)\n* Meconium aspiration system\n* Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)\n* Intracranial or subaleal hemorrhage\n* Hypotension requiring vasopressor support', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was intent to treat.'}, {'type': 'PRIMARY', 'title': 'Perinatal Death (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.12', 'ciUpperLimit': '3.33', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'antepartum pregnancy period through hospital discharge', 'description': 'Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.93', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery through discharge', 'description': 'Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.37', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery through 5 minutes after birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.37', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Neonatal Seizure (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '0.91', 'ciUpperLimit': '8.12', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery through discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Neonatal Infection (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.76', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'description': 'Neonatal infection includes confirmed sepsis and/or confirmed pneumonia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.19', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery through discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Birth Trauma (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.55', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the Delivery process', 'description': 'Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.48', 'ciUpperLimit': '3.42', 'estimateComment': 'Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through disharge', 'description': 'Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hypotension Requiring Vasopressor Support (Component of Primary Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.79', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '674', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.93', 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.92', 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': 'Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Neonatal length of hospital stay missing in 5 (2 induction group (IOL); 3 expectant-management group (EM)); incisional extensions at cesarean section missing in 9 (5 IOL; 4 EM); breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM).'}, {'type': 'SECONDARY', 'title': 'Participants Who Had Operative Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Chorioamnionitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time from randomization through delivery', 'description': 'Chorioamnionitis, defined as a clinical diagnosis before delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Third or Fourth Degree Perineal Laceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.52', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Maternal Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from randomization to hospital discharge', 'description': 'Maternal death at anytime between randomization and hospital discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Admitted to Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.55', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'description': 'Admission of the participant to the intensive care unit (ICU)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Hypertensive Disorder of Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.74', 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postpartum Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'description': 'defined as any of the following:\n\n* Transfusion\n* Non-elective hysterectomy\n* Use of two or more uterotonics other than oxytocin\n* Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade\n* Curettage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Labor Agentry Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': 'At 6-96 hr after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2876', 'groupId': 'OG000'}, {'value': '2932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '181'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '148', 'upperLimit': '183'}]}]}, {'title': 'At 4-8 weeks after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2650', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '188'}, {'value': '176', 'groupId': 'OG001', 'lowerLimit': '157', 'upperLimit': '189'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'groupDescription': 'Analysis for 6-96 hours after delivery', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'groupDescription': 'Analysis for 4-8 weeks after delivery', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Between 6 hours after delivery and 8 weeks after delivery', 'description': 'Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 6 to 96 hours after delivery are missing for 288 women (127 in the induction group and 161 in the expectant-management group); data for 4 to 8 weeks after delivery are missing for 736 women (349 in the induction group and 387 in the expectant-management group).'}, {'type': 'SECONDARY', 'title': 'Labor Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': 'Worst score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2873', 'groupId': 'OG000'}, {'value': '2949', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}, {'title': 'Overall score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2872', 'groupId': 'OG000'}, {'value': '2949', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'groupDescription': 'Analysis for Worst labor pain score', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'groupDescription': 'Analysis for Overall labor pain score', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'During labor and delivery', 'description': 'Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on worst score are missing for 274 women (110 in the induction group and 164 in the expectant-management group); data on overall score are missing for 275 women (110 in the induction group and 165 in the expectant-management group).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maternal Postpartum Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'description': 'Defined as any of the following:\n\n* Clinical diagnosis of endometritis\n* Wound reopened for hematoma, seroma, infection or other reasons\n* Cellulitis requiring antibiotics\n* Pneumonia\n* Pyelonephritis\n* Bacteremia - unknown source\n* Septic pelvic thrombosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '0.26', 'ciUpperLimit': '26.8', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'description': 'Maternal deep venous thrombosis or pulmonary embolism', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Indications for Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': 'Dystocia', 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}]}, {'title': 'Non-reassuring fetal status', 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}]}, {'title': 'Other c-section indication', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Labor and delivery', 'description': 'Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Respiratory Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': '0 days', 'categories': [{'measurements': [{'value': '2911', 'groupId': 'OG000'}, {'value': '2968', 'groupId': 'OG001'}]}]}, {'title': '1 day', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Greater than 1 day', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Armitage trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'description': 'including ventilator, CPAP, high-flow nasal cannula (HFNC)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One neonate had cardiorespiratory resuscitation and 0 days on mechanical ventilation, continuous positive airway pressure or high flow nasal cannula.'}, {'type': 'SECONDARY', 'title': 'Number of Infants With Cephalohematoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Shoulder Dystocia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Infants Who Had Transfusion of Blood Products or Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.74', 'estimateComment': 'Exact confidence intervals are provided for rare outcomes.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Infants With Hyperbilirubinemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'OG000'}, {'value': '3058', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'description': 'Hyperbilirubinemia requiring phototherapy or exchange transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were missing for 4 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Infants With Neonatal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.66', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through discharge', 'description': 'glucose \\< 35 mg/dl and requiring IV therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Infants Admitted to NICU or Intermediate Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'description': 'Number infants admitted to intensive care unit (NICU) or intermediate care unit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hours on the Labor and Delivery Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3036', 'groupId': 'OG000'}, {'value': '3058', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon Rank-Sum', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hours from admission to L&D to discharge from L&D', 'description': 'Median duration of stay in labor and delivery unit', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes 7 women who delivered before admission to the labor and delivery unit. Data are missing for 2 women.'}, {'type': 'SECONDARY', 'title': 'Maternal Postpartum Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'title': '<2 days', 'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}, {'title': '2 days', 'measurements': [{'value': '2084', 'groupId': 'OG000'}, {'value': '2191', 'groupId': 'OG001'}]}, {'title': '3 days', 'measurements': [{'value': '452', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}, {'title': '4 days', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'title': '>4 days', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'statisticalMethod': 'Cochran-Armitage trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3034', 'groupId': 'OG000'}, {'value': '3057', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'categories': [{'title': '<2 days', 'measurements': [{'value': '315', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}, {'title': '2 days', 'measurements': [{'value': '1904', 'groupId': 'OG000'}, {'value': '2030', 'groupId': 'OG001'}]}, {'title': '3 days', 'measurements': [{'value': '498', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}]}, {'title': '4 days', 'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}, {'title': '>4 days', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The P value remained significant after controlling for multiple comparisons with the false discovery rate method.', 'statisticalMethod': 'Cochran-Armitage trend test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery through hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is missing for 5 participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Indications for Operative Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': 'Dystocia', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Non-reassuring fetal status', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Other indication', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Labor and delivery', 'description': 'Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3037', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'OG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'classes': [{'title': 'Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2694', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '891', 'groupId': 'OG000'}, {'value': '916', 'groupId': 'OG001'}]}]}, {'title': 'Breast Feeding and Formula Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2694', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '831', 'groupId': 'OG000'}, {'value': '863', 'groupId': 'OG001'}]}]}, {'title': 'Formula Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2694', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '972', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.15', 'pValueComment': 'Odds ratios from multinomial logistic regression.', 'groupDescription': 'Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.12', 'groupDescription': 'Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-8 weeks after delivery', 'description': 'Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'FG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3044'}, {'groupId': 'FG001', 'numSubjects': '3062'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3037'}, {'groupId': 'FG001', 'numSubjects': '3059'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '50,581 low-risk nulliparous women at 34 weeks 0 days gestation to 38 weeks 6 days gestation were screened for eligibility between March 2014 and August 2017 at 41 hospitals participating in the MFMU network. Women who consented were assessed again between 38 weeks 0 days gestation and 38 weeks 6 days gestation for new indications of ineligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'id': 'BG001', 'title': 'Elective Induction of Labor', 'description': "Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days\n\nElective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '28'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '≥35 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1359', 'groupId': 'BG000'}, {'value': '1329', 'groupId': 'BG001'}, {'value': '2688', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '699', 'groupId': 'BG000'}, {'value': '707', 'groupId': 'BG001'}, {'value': '1406', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '808', 'groupId': 'BG000'}, {'value': '866', 'groupId': 'BG001'}, {'value': '1674', 'groupId': 'BG002'}]}]}, {'title': 'Other, unknown or more than one race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Married or living with partner', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1798', 'groupId': 'BG000'}, {'value': '1814', 'groupId': 'BG001'}, {'value': '3612', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3036', 'groupId': 'BG000'}, {'value': '3053', 'groupId': 'BG001'}, {'value': '6089', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed full time', 'measurements': [{'value': '1209', 'groupId': 'BG000'}, {'value': '1226', 'groupId': 'BG001'}, {'value': '2435', 'groupId': 'BG002'}]}, {'title': 'Employed part time', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '694', 'groupId': 'BG002'}]}, {'title': 'Not employed', 'measurements': [{'value': '1474', 'groupId': 'BG000'}, {'value': '1486', 'groupId': 'BG001'}, {'value': '2960', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data on employment status are missing for a total of 17 women.'}, {'title': 'Private insurance for prenatal care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3061', 'groupId': 'BG001'}, {'value': '6105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1335', 'groupId': 'BG000'}, {'value': '1404', 'groupId': 'BG001'}, {'value': '2739', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is missing for one participant.'}, {'title': 'History of pregnancy loss', 'classes': [{'title': 'No previous pregnancy loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2266', 'groupId': 'BG000'}, {'value': '2364', 'groupId': 'BG001'}, {'value': '4630', 'groupId': 'BG002'}]}]}, {'title': 'Previous pregnancy loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '778', 'groupId': 'BG000'}, {'value': '698', 'groupId': 'BG001'}, {'value': '1476', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Length of gestation at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'BG000', 'lowerLimit': '38.0', 'upperLimit': '38.6'}, {'value': '38.3', 'groupId': 'BG001', 'lowerLimit': '38.0', 'upperLimit': '38.6'}, {'value': '38.3', 'groupId': 'BG002', 'lowerLimit': '38.0', 'upperLimit': '38.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Method of conception', 'classes': [{'title': 'In vitro fertilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Ovulation inducation or artificial insemination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Spontaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2973', 'groupId': 'BG000'}, {'value': '2976', 'groupId': 'BG001'}, {'value': '5949', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoked cigarettes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3044', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drank alcohol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3043', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are missing for 1 participant'}, {'title': 'BMI at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3027', 'groupId': 'BG000'}, {'value': '3049', 'groupId': 'BG001'}, {'value': '6076', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '27.3', 'upperLimit': '35.0'}, {'value': '30.5', 'groupId': 'BG001', 'lowerLimit': '27.3', 'upperLimit': '34.6'}, {'value': '30.4', 'groupId': 'BG002', 'lowerLimit': '27.3', 'upperLimit': '34.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Data are missing for 30 women'}, {'title': 'BMI ≥30 at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3027', 'groupId': 'BG000'}, {'value': '3049', 'groupId': 'BG001'}, {'value': '6076', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1575', 'groupId': 'BG000'}, {'value': '1632', 'groupId': 'BG001'}, {'value': '3207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants who had a body-mass index (BMI) of greater than or equal to 30 at randomization. BMI is weight in kilograms divided by the square of the height in meters.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are missing for 30 women'}, {'title': 'Modified Bishop Score at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3042', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Modified Bishop scores range from 0 to 12, with lower scores associated with a higher chance of cesarean delivery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Data is missing for 2 participants.'}, {'title': 'Modified Bishop score <5 at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3042', 'groupId': 'BG000'}, {'value': '3062', 'groupId': 'BG001'}, {'value': '6104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1954', 'groupId': 'BG000'}, {'value': '1919', 'groupId': 'BG001'}, {'value': '3873', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Modified Bishop scores range from 0 to 12, with lower scores associated with a higher chance of cesarean delivery', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data is missing for 2 participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-10-31', 'size': 1368181, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-11-14T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2013-11-15', 'resultsFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Severe Neonatal Morbidity and Perinatal Mortality', 'timeFrame': 'delivery through 72 hours after birth', 'description': 'Includes any one of:\n\n* Perinatal death\n* Need for respiratory support within 72 hours after birth\n* Apgar score of 3 or less at 5 minutes\n* Hypoxic-ischemic encephalopathy\n* Seizure\n* Infection (confirmed sepsis or pneumonia)\n* Meconium aspiration system\n* Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)\n* Intracranial or subaleal hemorrhage\n* Hypotension requiring vasopressor support'}, {'measure': 'Perinatal Death (Component of Primary Outcome)', 'timeFrame': 'antepartum pregnancy period through hospital discharge', 'description': 'Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death'}, {'measure': 'Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)', 'timeFrame': 'Delivery through discharge', 'description': 'Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation'}, {'measure': 'Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)', 'timeFrame': 'Delivery through 5 minutes after birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}, {'measure': 'Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)', 'timeFrame': 'delivery through discharge'}, {'measure': 'Number of Infants With Neonatal Seizure (Component of Primary Outcome)', 'timeFrame': 'Delivery through discharge'}, {'measure': 'Number of Infants With Neonatal Infection (Component of Primary Outcome)', 'timeFrame': 'delivery through discharge', 'description': 'Neonatal infection includes confirmed sepsis and/or confirmed pneumonia'}, {'measure': 'Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)', 'timeFrame': 'Delivery through discharge'}, {'measure': 'Number of Infants With Birth Trauma (Component of Primary Outcome)', 'timeFrame': 'During the Delivery process', 'description': 'Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis'}, {'measure': 'Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)', 'timeFrame': 'delivery through disharge', 'description': 'Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma'}, {'measure': 'Hypotension Requiring Vasopressor Support (Component of Primary Outcome)', 'timeFrame': 'delivery through discharge'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cesarean Delivery', 'timeFrame': 'delivery'}, {'measure': 'Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery', 'timeFrame': 'delivery', 'description': 'Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas'}, {'measure': 'Participants Who Had Operative Vaginal Delivery', 'timeFrame': 'delivery'}, {'measure': 'Number of Participants Who Had Chorioamnionitis', 'timeFrame': 'at any time from randomization through delivery', 'description': 'Chorioamnionitis, defined as a clinical diagnosis before delivery'}, {'measure': 'Number of Participants With Third or Fourth Degree Perineal Laceration', 'timeFrame': 'delivery'}, {'measure': 'Number of Maternal Deaths', 'timeFrame': 'from randomization to hospital discharge', 'description': 'Maternal death at anytime between randomization and hospital discharge.'}, {'measure': 'Number of Participants Admitted to Intensive Care Unit (ICU)', 'timeFrame': 'delivery through hospital discharge', 'description': 'Admission of the participant to the intensive care unit (ICU)'}, {'measure': 'Number of Participants Experiencing Hypertensive Disorder of Pregnancy', 'timeFrame': 'Randomization to hospital discharge'}, {'measure': 'Number of Participants With Postpartum Hemorrhage', 'timeFrame': 'delivery through hospital discharge', 'description': 'defined as any of the following:\n\n* Transfusion\n* Non-elective hysterectomy\n* Use of two or more uterotonics other than oxytocin\n* Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade\n* Curettage'}, {'measure': 'Labor Agentry Scale Scores', 'timeFrame': 'Between 6 hours after delivery and 8 weeks after delivery', 'description': 'Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.'}, {'measure': 'Labor Pain Scores', 'timeFrame': 'During labor and delivery', 'description': 'Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.'}, {'measure': 'Number of Participants With Maternal Postpartum Infection', 'timeFrame': 'delivery through discharge', 'description': 'Defined as any of the following:\n\n* Clinical diagnosis of endometritis\n* Wound reopened for hematoma, seroma, infection or other reasons\n* Cellulitis requiring antibiotics\n* Pneumonia\n* Pyelonephritis\n* Bacteremia - unknown source\n* Septic pelvic thrombosis'}, {'measure': 'Number of Participants With Venous Thromboembolism', 'timeFrame': 'delivery through discharge', 'description': 'Maternal deep venous thrombosis or pulmonary embolism'}, {'measure': 'Number of Participants With Indications for Cesarean Delivery', 'timeFrame': 'Labor and delivery', 'description': 'Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication'}, {'measure': 'Duration of Respiratory Support', 'timeFrame': 'delivery through hospital discharge', 'description': 'including ventilator, CPAP, high-flow nasal cannula (HFNC)'}, {'measure': 'Number of Infants With Cephalohematoma', 'timeFrame': 'delivery through hospital discharge'}, {'measure': 'Shoulder Dystocia', 'timeFrame': 'delivery'}, {'measure': 'Number of Infants Who Had Transfusion of Blood Products or Blood', 'timeFrame': 'delivery through hospital discharge'}, {'measure': 'Number of Infants With Hyperbilirubinemia', 'timeFrame': 'delivery through discharge', 'description': 'Hyperbilirubinemia requiring phototherapy or exchange transfusion'}, {'measure': 'Number of Infants With Neonatal Hypoglycemia', 'timeFrame': 'delivery through discharge', 'description': 'glucose \\< 35 mg/dl and requiring IV therapy'}, {'measure': 'Number Infants Admitted to NICU or Intermediate Care', 'timeFrame': 'delivery through hospital discharge', 'description': 'Number infants admitted to intensive care unit (NICU) or intermediate care unit'}, {'measure': 'Number of Hours on the Labor and Delivery Unit', 'timeFrame': 'Hours from admission to L&D to discharge from L&D', 'description': 'Median duration of stay in labor and delivery unit'}, {'measure': 'Maternal Postpartum Length of Hospital Stay', 'timeFrame': 'delivery through hospital discharge'}, {'measure': 'Neonatal Length of Hospital Stay', 'timeFrame': 'delivery through hospital discharge'}, {'measure': 'Number of Participants With Indications for Operative Vaginal Delivery', 'timeFrame': 'Labor and delivery', 'description': 'Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications'}, {'measure': 'Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery', 'timeFrame': '4-8 weeks after delivery', 'description': 'Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Induction of labor', 'Expectant management of labor', '39 weeks gestation'], 'conditions': ['Labor and Delivery']}, 'referencesModule': {'references': [{'pmid': '30089070', 'type': 'RESULT', 'citation': 'Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.'}, {'pmid': '37290106', 'type': 'DERIVED', 'citation': 'Mallett G, Hill K, Doherty L, Grobman WA, Reddy UM, Tita ATN, Silver RM, Rice MM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Costantine MM, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN, Macones GA; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor. Obstet Gynecol. 2023 Jul 1;142(1):117-124. doi: 10.1097/AOG.0000000000005230.'}, {'pmid': '35576345', 'type': 'DERIVED', 'citation': 'Costantine MM, Sandoval GJ, Grobman WA, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation. Obstet Gynecol. 2022 May 1;139(5):866-876. doi: 10.1097/AOG.0000000000004753. Epub 2022 Apr 5.'}, {'pmid': '32925634', 'type': 'DERIVED', 'citation': 'Silver RM, Rice MM, Grobman WA, Reddy UM, Tita ATN, Mallett G, Hill K, Thom EA, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation. Obstet Gynecol. 2020 Oct;136(4):698-705. doi: 10.1097/AOG.0000000000004046.'}, {'pmid': '32925629', 'type': 'DERIVED', 'citation': 'Mallett G, Hill K, de Voest J, Bousleiman SZ, Allard D, Harris S, Salazar A, Clark K, Ortiz F, Bartholomew A, Dalton W, Craig J, Bickus M; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy. Obstet Gynecol. 2020 Oct;136(4):731-737. doi: 10.1097/AOG.0000000000003998.'}, {'pmid': '32925628', 'type': 'DERIVED', 'citation': 'El-Sayed YY, Rice MM, Grobman WA, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women. Obstet Gynecol. 2020 Oct;136(4):692-697. doi: 10.1097/AOG.0000000000004055.'}, {'pmid': '32028504', 'type': 'DERIVED', 'citation': 'Dude A, Fette LM, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Iams JD, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal Sense of Control During Childbirth and Infant Feeding Method. Obstet Gynecol. 2020 Mar;135(3):583-590. doi: 10.1097/AOG.0000000000003697.'}]}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.', 'detailedDescription': 'Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nulliparous - no previous pregnancy beyond 20 weeks\n2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.\n3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.\n\nExclusion Criteria:\n\n1. Project gestational age at date of first ultrasound is \\> 20 weeks 6 days\n2. Plan for induction of labor prior to 40 weeks 5 days\n3. Plan for cesarean delivery or contraindication to labor\n4. Breech presentation\n5. Signs of labor (regular painful contractions with cervical change)\n6. Fetal demise or known major fetal anomaly\n7. Heparin or low-molecular weight heparin during the current pregnancy\n8. Placenta previa, accreta, vasa previa\n9. Active vaginal bleeding greater than bloody show\n10. Ruptured membranes\n11. Cerclage in current pregnancy\n12. Known oligohydramnios, defined as AFI \\< 5 or MVP \\< 2\n13. Fetal growth restriction, defined as EFW \\< 10th percentile\n14. Known HIV positivity because of modified delivery plan\n15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)\n16. Refusal of blood products\n17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality\n18. Delivery planned elsewhere at a non-Network site'}, 'identificationModule': {'nctId': 'NCT01990612', 'acronym': 'ARRIVE', 'briefTitle': 'A Randomized Trial of Induction Versus Expectant Management', 'organization': {'class': 'OTHER', 'fullName': 'The George Washington University Biostatistics Center'}, 'officialTitle': 'Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HD36801-ARRIVE'}, 'secondaryIdInfos': [{'id': 'UG1HD027869', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027869', 'type': 'NIH'}, {'id': 'UG1HD027915', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027915', 'type': 'NIH'}, {'id': 'UG1HD034116', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD034116', 'type': 'NIH'}, {'id': 'UG1HD034208', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD034208', 'type': 'NIH'}, {'id': 'UG1HD040500', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040500', 'type': 'NIH'}, {'id': 'UG1HD040485', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040485', 'type': 'NIH'}, {'id': 'UG1HD040544', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040544', 'type': 'NIH'}, {'id': 'UG1HD053097', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD053097', 'type': 'NIH'}, {'id': 'UG1HD040545', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040545', 'type': 'NIH'}, {'id': 'UG1HD040560', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040560', 'type': 'NIH'}, {'id': 'UG1HD087230', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD087230', 'type': 'NIH'}, {'id': 'UG1HD087192', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD087192', 'type': 'NIH'}, {'id': 'UG1HD040512', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040512', 'type': 'NIH'}, {'id': 'UG1HD068258', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068258', 'type': 'NIH'}, {'id': 'UG1HD068268', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068268', 'type': 'NIH'}, {'id': 'U10HD036801', 'link': 'https://reporter.nih.gov/quickSearch/U10HD036801', 'type': 'NIH'}, {'id': 'UG1HD068282', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068282', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Expectant Management', 'description': 'Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.'}, {'type': 'OTHER', 'label': 'Elective Induction of Labor', 'description': 'Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days', 'interventionNames': ['Procedure: Elective Induction of Labor']}], 'interventions': [{'name': 'Elective Induction of Labor', 'type': 'PROCEDURE', 'description': "Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \\< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.", 'armGroupLabels': ['Elective Induction of Labor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94305-5317', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University-Prentice Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Columbia University-St. Luke's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235-9032', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dept of OB/GYN, Southwestern Medical Center, University of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Menachem Miodovnik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, {'name': 'Rebecca Clifton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Washington University Biostatistics Center'}, {'name': 'William Grobman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Washington University Biostatistics Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}