Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-03-09 @ 5:50 AM
Study NCT ID:
NCT02659605
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cord Clamping Level Above or Below Mother's Perineum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Pamela.D.Berens@uth.tmc.edu', 'phone': '(713) 500-6471', 'title': 'Dr. Pamela D. Berens', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Inability to blind participants and medical staff involved in the delivery. Data for some subjects was not obtained due to systems errors.'}}, 'adverseEventsModule': {'timeFrame': 'during the initial hospital stay (1-2 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.", 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hematocrit Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.572', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'MEAN', 'timeFrame': '24 hours after delivery', 'unitOfMeasure': '% of blood composed of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.849', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the initial hospital stay (1-2 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infants Who Received Phototherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.886', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the initial hospital stay (1-2 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infants Who Received Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.612', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the initial hospital stay (1-2 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apgar Score at 1 Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.728', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'MEAN', 'timeFrame': '1 minute after birth', 'description': 'The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Apgar Score at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'OG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.584', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after birth', 'description': 'The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'FG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '103 subjects were consented, but 29 were determined to be ineligible prior to randomization (that is, 29 did not start the study).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delayed Cord Clamping Above the Perineum', 'description': "Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant."}, {'id': 'BG001', 'title': 'Delayed Cord Clamping Below the Perineum', 'description': 'Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'less than 25 kg/m^2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'greater than or equal to 25 kg/m^2 and below 30 kg', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'greater than or equal to 30 kg/m^2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '# previous pregnancies carried to term', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insurance', 'classes': [{'title': 'none/self-pay', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'private', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prenatal care', 'classes': [{'title': 'prenatal care', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'no prenatal care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Induced', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age in weeks', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age greater than or equal to 32 weeks', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2016-02-29', 'size': 274949, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-18T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2016-01-15', 'resultsFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-31', 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematocrit Level', 'timeFrame': '24 hours after delivery'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)', 'timeFrame': 'during the initial hospital stay (1-2 days)'}, {'measure': 'Number of Participants With Infants Who Received Phototherapy', 'timeFrame': 'during the initial hospital stay (1-2 days)'}, {'measure': 'Number of Participants With Infants Who Received Blood Transfusion', 'timeFrame': 'during the initial hospital stay (1-2 days)'}, {'measure': 'Apgar Score at 1 Minute', 'timeFrame': '1 minute after birth', 'description': 'The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.'}, {'measure': 'Apgar Score at 5 Minutes', 'timeFrame': '5 minutes after birth', 'description': 'The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pre-term birth', 'delayed cord clamping', 'skin to skin'], 'conditions': ['Pre-term Birth', 'Delayed Cord Clamping']}, 'referencesModule': {'references': [{'pmid': '26651542', 'type': 'BACKGROUND', 'citation': 'Mansaray A, Yetman R, Berens P. Effect of Delayed Cord Clamping Above Versus Below the Perineum on Neonatal Hematocrit: A Randomized Controlled Trial. Breastfeed Med. 2015 Dec;10(10):464-7. doi: 10.1089/bfm.2015.0109.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.', 'detailedDescription': "This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn.\n\nPatients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation\n\nExclusion Criteria:\n\n* Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders\n* Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption\n* Infants who are not anticipated to undergo spontaneous vaginal delivery'}, 'identificationModule': {'nctId': 'NCT02659605', 'acronym': 'CLAMP', 'briefTitle': "Cord Clamping Level Above or Below Mother's Perineum", 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': "Cord Clamping Level Above or Below Mother's Perineum", 'orgStudyIdInfo': {'id': 'HSC-MS-11-0633'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delayed cord clamping above the perineum', 'interventionNames': ['Procedure: Delayed cord clamping above the perineum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed cord clamping below the perineum', 'interventionNames': ['Procedure: Delayed cord clamping below the perineum']}], 'interventions': [{'name': 'Delayed cord clamping above the perineum', 'type': 'PROCEDURE', 'description': "After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.", 'armGroupLabels': ['Delayed cord clamping above the perineum']}, {'name': 'Delayed cord clamping below the perineum', 'type': 'PROCEDURE', 'description': 'The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.', 'armGroupLabels': ['Delayed cord clamping below the perineum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Pamela Berens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Berens', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}