Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT01818518
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neonatal Outcome by Reason for Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimberly_maurel@mednax.com', 'phone': '714-593-9171', 'title': 'Kimberly Maurel', 'organization': 'Mednax. Inc'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'No adverse events were assessed from the beginning through the duration of the study. This is an observational study and therefore adverse events were not assessed.', 'description': 'All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed in this observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'Preterm Labor', 'description': 'Group who goes into labor prior to 32 weeks of gestation', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prelabor Rupture of Membranes', 'description': 'Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'IUGR Diagnosis on Admission', 'description': 'Group who have the diagnosis of intrauterine growth restriction on admission to the hospital.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pre-Eclampsia Diagnosis on Admission', 'description': 'Group who have the diagnosis of pre-eclampsia noted on admission to the hospital', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vaginal Bleeding Diagnosis on Admission', 'description': 'Group who have the presence of vaginal bleeding noted at the time of admission to the hospital', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Short Cervix Diagnosis on Admission', 'description': 'Group who have the diagnosis of a short cervical length at the time of admission to the hospital', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Perinatal Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prelabor Rupture of Membranes Diagnosis on Admission', 'description': 'Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission'}, {'id': 'OG001', 'title': 'Preterm Labor Diagnosis on Admission', 'description': 'Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission'}, {'id': 'OG002', 'title': 'Pre-eclampsia Diagnosis on Admission', 'description': 'The diagnosis of Preeclampsia at time of admission'}, {'id': 'OG003', 'title': 'IUGR Diagnosis on Admission', 'description': 'The diagnosis of IUGR at time of admission'}, {'id': 'OG004', 'title': 'Vaginal Bleeding Diagnosis on Admission', 'description': 'The diagnosis of vaginal bleeding made at time of admission'}, {'id': 'OG005', 'title': 'Short Cervix Diagnosis on Admission', 'description': 'The diagnosis of Short cervical length at time of admission'}], 'classes': [{'title': 'Composite Morbidity', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}, {'title': 'Serious Morbidity', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'Perinatal (infant) Death', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Respiratory distress syndrome (RDS)', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'On Ventilatory at 28 days of age', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Intraventicular Hemorrhage Grade 3 or 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Necrotizing Enterocolitis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Periventricular Leukomalacia (PVL)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Cord arterial pH < 7.1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Cord venous pH <7.1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Arterial base excess < -12', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Venous Base Excess < -12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Five-minute Apgar score < 5', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Infants from birth until discharge or until infant reaches 28 days of life.', 'description': 'The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Composite morbidity is defined as ≥ 1 of the following: RDS, BPD, severe IVH (grades III or IV), PVL, blood culture-proven sepsis present within 72 hours of birth, NEC, or perinatal death. Perinatal Morbidity assessed pertains to the newborns born to the enrolled female patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prelabor Rupture of Membranes Diagnosis on Admission', 'description': 'Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission'}, {'id': 'FG001', 'title': 'Preterm Labor Diagnosis on Admission', 'description': 'Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission'}, {'id': 'FG002', 'title': 'Pre-eclampsia Diagnosis on Admission', 'description': 'The diagnosis of Preeclampsia at time of admission'}, {'id': 'FG003', 'title': 'Intrauterine Growth Restriction (IUGR) Diagnosis on Admission', 'description': 'The diagnosis of IUGR at time of admission'}, {'id': 'FG004', 'title': 'Vaginal Bleeding Diagnosis on Admission', 'description': 'The diagnosis of vaginal bleeding made at time of admission'}, {'id': 'FG005', 'title': 'Short Cervix Diagnosis on Admission', 'description': 'The diagnosis of Short cervical length at time of admission'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '263'}, {'groupId': 'FG002', 'numSubjects': '288'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '263'}, {'groupId': 'FG002', 'numSubjects': '288'}, {'groupId': 'FG003', 'numSubjects': '59'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Prelabor Rupture of Membranes Diagnosis on Admission', 'description': 'Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission'}, {'id': 'BG001', 'title': 'Preterm Labor Diagnosis on Admission', 'description': 'Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission'}, {'id': 'BG002', 'title': 'Pre-eclampsia Diagnosis on Admission', 'description': 'The diagnosis of Preeclampsia at time of admission'}, {'id': 'BG003', 'title': 'IUGR Diagnosis on Admission', 'description': 'The diagnosis of IUGR at time of admission'}, {'id': 'BG004', 'title': 'Vaginal Bleeding Diagnosis on Admission', 'description': 'The diagnosis of vaginal bleeding made at time of admission'}, {'id': 'BG005', 'title': 'Short Cervix Diagnosis on Admission', 'description': 'The diagnosis of Short cervical length at time of admission'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '28.6', 'spread': '5.6', 'groupId': 'BG003'}, {'value': '28.9', 'spread': '6.2', 'groupId': 'BG004'}, {'value': '29.4', 'spread': '5.6', 'groupId': 'BG005'}, {'value': '29.1', 'spread': '5.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '971', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '517', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '971', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '197', 'groupId': 'BG006'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '971', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '971', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '971', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '118', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were able to indicate more than one Race/Ethnicity in their response.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all ethnicity data was available for all participants enrolled in the study and participants were able to select more than one Race/Ethnicity when applicable.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nulliparity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '956', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '387', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.'}, {'title': 'Prenatal Care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '968', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '934', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Measure Analysis Population Description: number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown'}, {'title': 'Gestational Age at admission , wks', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '28.2', 'spread': '2.3', 'groupId': 'BG003'}, {'value': '26.7', 'spread': '2.9', 'groupId': 'BG004'}, {'value': '24.4', 'spread': '2.3', 'groupId': 'BG005'}, {'value': '27.0', 'spread': '2.5', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational Age at delivery, wks', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '28.9', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '29.1', 'spread': '2.2', 'groupId': 'BG003'}, {'value': '27.4', 'spread': '2.6', 'groupId': 'BG004'}, {'value': '26.3', 'spread': '2.6', 'groupId': 'BG005'}, {'value': '28.1', 'spread': '2.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Interval from admission to delivery, wks.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '0.9', 'spread': '1.1', 'groupId': 'BG003'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'BG004'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'BG005'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cesarean delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '660', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received full course of antenatal corticosteroids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '512', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A full course was determined by evaluation of the medical record to verify that two doses of antenatal corticosteroid prior to rupture of membranes and each dose was administered 24 hours apart.', 'unitOfMeasure': 'Participants'}, {'title': 'Male newborn', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '551', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = spontaneous labor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '433', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = preeclampsia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '222', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = fetal heart rate nonreassuring', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '173', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = chorioamnionitis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = Bleeding', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary reason for delivery = Other', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '995', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 995}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2013-03-21', 'resultsFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-05', 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Perinatal Morbidity', 'timeFrame': 'Infants from birth until discharge or until infant reaches 28 days of life.', 'description': 'The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm delivery', 'Premature delivery', 'Premature birth'], 'conditions': ['Preterm Delivery']}, 'descriptionModule': {'briefSummary': 'To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.', 'detailedDescription': 'This is a prospective, observational study that will use information from the medical records of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.\n\nSecondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite morbidity differences for other reasons for premature delivery, and individual morbidities including IVH, PVL, RDS, sepsis, seizures, BPD and NEC\n\nStudy Population: All babies from singleton pregnancies delivering in each of the involved hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.\n\nPlanned Sample Size: We plan a two year study and estimate based on historical data for the institutions to be included in the study, which should yield approximately 6000 babies less than (\\<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the 3 groups (PTL, PROM, and other).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating\n* Singleton pregnancy\n* Delivery where the baby is:\n\n 1. Stillborn OR\n 2. Born alive and:\n* expires before it leaves the delivery room OR\n* is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery\n\nExclusion Criteria:\n\n* Patient less than 18 years of age\n* Pregnancies that had previously been multiple gestations but where one or more fetuses had died after 12weeks of gestation\n* Deliveries where the baby is born alive, does not expire in the delivery room but the baby does not get admitted to the NICU.'}, 'identificationModule': {'nctId': 'NCT01818518', 'briefTitle': 'Neonatal Outcome by Reason for Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'OBX0022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm Labor', 'description': 'Group who goes into labor prior to 32 weeks of gestation'}, {'label': 'Prelabor rupture of membranes', 'description': 'Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.'}, {'label': 'Premature birth before 32 weeks gestation', 'description': 'Premature birth before 32 weeks gestation not including PTL or PROM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Desert Medical Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare-Shea Medical Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '95008', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian/St Luke's Hospital", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital, Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Harris Methodist Hospital - Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98122-4307', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Thomas Garite, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrix Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrix Medical Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}