Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00187369
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jon.barrett@sunnybrook.ca', 'title': 'Dr Jon Barrett', 'organization': 'Sunnybrook Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Fusion and adverse events were connected and baby. There were no serious adverse Maternal events.', 'eventGroups': [{'id': 'EG000', 'title': 'Planned Caesarean Section-Mother', 'description': 'delivery by CS or Method of Delivery: CS or VB', 'otherNumAtRisk': 1392, 'deathsNumAtRisk': 1392, 'otherNumAffected': 0, 'seriousNumAtRisk': 1392, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Planned Vaginal Birth-Mother', 'description': 'delivery by VB or Method of Delivery: CS or VB', 'otherNumAtRisk': 1392, 'deathsNumAtRisk': 1392, 'otherNumAffected': 0, 'seriousNumAtRisk': 1392, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Planned Caesarean Section-Infants/Fetuses', 'description': 'delivery by CS or Method of Delivery: CS or VB', 'otherNumAtRisk': 2783, 'deathsNumAtRisk': 2783, 'otherNumAffected': 0, 'seriousNumAtRisk': 2783, 'deathsNumAffected': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Planned Vaginal Birth-Infants/Fetuses', 'description': 'delivery by VB or Method of Delivery: CS or VB', 'otherNumAtRisk': 2782, 'deathsNumAtRisk': 2782, 'otherNumAffected': 0, 'seriousNumAtRisk': 2782, 'deathsNumAffected': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2783', 'groupId': 'OG000'}, {'value': '2782', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'title': 'Composite primary outcome', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Fetal death', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal death', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Serious neonatal morbidity', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'until 28 days after delivery', 'description': 'The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'number of fetuses/infants'}, {'type': 'SECONDARY', 'title': 'Neonatal Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2759', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by caesarean section\n\nMethod of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by vaginal birth\n\nMethod of Delivery: CS or VB'}], 'classes': [{'title': 'Long bone fracture', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other bone fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Facial-nerve injury at 72 hr of age or discharge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intracerebral hemmorrhage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Apgar score at 5 minutes less than 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Coma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stupor or decreased response to pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperalert, drowsy, or lethargic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '≥2 seizures within 72 hr after birth', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Assisted ventilation for ≥24 hr by means of endotr', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Neonatal sepsis within 72 hours after birth', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis within 72 hours after birth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Necrotizing enterocolitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Broncho-pulmonary dysplasia (BPD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 or 4 intraventricular hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cystic periventricular leukomalacia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'until 28 days after delivery', 'description': 'Neonatal morbidity, excluding death of either twin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by caesarean section\n\nMethod of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by vaginal birth\n\nMethod of Delivery: CS or VB'}], 'classes': [{'title': 'Fetal or neonatal death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Death up to follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Neurodevelopmental delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2285', 'groupId': 'OG000'}, {'value': '2260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Cerebral palsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2285', 'groupId': 'OG000'}, {'value': '2260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Motor delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2285', 'groupId': 'OG000'}, {'value': '2260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Neurodevelopmental outcome will be assessed by the Ages and Stages Questionnaire (ASQ). The ASQ is a parent/parental caregiver-administered structured questionnaire that includes questions on 5 domains of development: communication, gross motor skills, fine motor skills, problem-solving skills, and personal-social skills. If the score for any 1 of the 5 domains is below the specific cutoff for the domain, the ASQ was considered abnormal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Neurodevelopmental outcomes of children at 2 years of age (based on available two year data of the children).'}, {'type': 'SECONDARY', 'title': 'Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS\n\nMethod of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB\n\nMethod of Delivery: CS or VB'}], 'classes': [{'title': 'Urinary incontinence', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}, {'title': 'Problematic urinary incontinence', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Fecal incontinence', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Problematic faecal incontinence', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Flatal incontinence', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}, {'title': 'Problematic flatal incontinence', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years postpartum', 'description': 'The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Characteristics - Gestational Age at Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'OG000'}, {'value': '1393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Basline', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Characteristics - Estimated Fetal Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'OG000'}, {'value': '1393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'title': 'First Twin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1391', 'groupId': 'OG000'}, {'value': '1391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2238', 'spread': '424', 'groupId': 'OG000'}, {'value': '2238', 'spread': '419', 'groupId': 'OG001'}]}]}, {'title': 'Second Twin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1391', 'groupId': 'OG000'}, {'value': '1392', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2223', 'spread': '413', 'groupId': 'OG000'}, {'value': '2232', 'spread': '422', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Basline', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were missing for the following characteristics: estimated fetal weight of the first twin (for two women in the planned-cesarean-delivery group and for two in the planned-vaginal-delivery group) and estimated fetal weight of the second twin (for two women in the planned-cesarean-delivery group and for one in the planned-vaginal-delivery group)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Other Maternal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'title': 'Depression (EPDS >12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Continuing breast feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1129', 'groupId': 'OG000'}, {'value': '1124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years postpartum', 'description': 'Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Other Maternal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1141', 'groupId': 'OG000'}, {'value': '1134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'title': 'Maternal quality of life (SF-36) Physical', 'categories': [{'measurements': [{'value': '53.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Maternal quality of life (SF-36) Mental', 'categories': [{'measurements': [{'value': '47.9', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '48.1', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year postpartum', 'description': "Maternal quality of life at 2 years postpartum (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability);", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean and standard deviation on available data. This is based on available maternal data at 2 years postpartum.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Other Maternal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1285', 'groupId': 'OG000'}, {'value': '1285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS or Method of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB or Method of Delivery: CS or VB'}], 'classes': [{'title': '>12 (probable depression)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': '≥10 (possible depression', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}]}, {'title': 'Experienced any urinary incontinence', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Problematic urinary incontinence', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Experienced faecal incontinence', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Problematic faecal incontinence', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Experienced incontinence of flatus', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'Problematic flatal incontinence', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Breastfed either baby at any time', 'categories': [{'measurements': [{'value': '1084', 'groupId': 'OG000'}, {'value': '1110', 'groupId': 'OG001'}]}]}, {'title': 'Stopped breastfeeding at <15 days', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postpartum', 'description': 'Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Other Maternal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1285', 'groupId': 'OG000'}, {'value': '1285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Planned Caesarean Section', 'description': 'delivery by CS\n\nMethod of Delivery: CS or VB'}, {'id': 'OG001', 'title': 'Planned Vaginal Birth', 'description': 'delivery by VB\n\nMethod of Delivery: CS or VB'}], 'classes': [{'title': 'Maternal quality of life (SF-36) Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1258', 'groupId': 'OG000'}, {'value': '1260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Maternal quality of life (SF-36) Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1258', 'groupId': 'OG000'}, {'value': '1260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Global Fatigue Index score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'OG000'}, {'value': '1251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Edinburgh Postnatal Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}, {'value': '1282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Incontinence Impact Questionnaire-7 (IIQ-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.48', 'spread': '21.41', 'groupId': 'OG000'}, {'value': '20.44', 'spread': '20.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postpartum', 'description': "Maternal quality of life at 3 months (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability); Maternal fatigue at 3 months (the scale combines 16 items to produce a Global Fatigue Index (GFI), which can range from 1 (no fatigue) to 50 (severe fatigue)); Maternal depression at 3 months was measured by the Edinburgh Postnatal Depression Scale, which measures how women have been feeling in the previous 7 days, with a score of \\>12 indicating depression (each answer is given a score of 0 to 3 based on the seriousness of the symptom. The total possible maximum depression score is 30). IIQ-7 at 3 months are validated questions about the impact of the incontinence (scores were reported using a scale of 0-100, with '0' indicating no impact at all and '100' greatly impacted).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean and standard deviation on available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caesarean Section', 'description': 'delivery by caesarean section\n\nMethod of Delivery: CS or VB'}, {'id': 'FG001', 'title': 'Vaginal Birth', 'description': 'delivery by vaginal birth\n\nMethod of Delivery: CS or VB'}], 'periods': [{'title': 'Mothers', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1398'}, {'groupId': 'FG001', 'numSubjects': '1406'}]}, {'type': 'Included in the Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1393'}, {'groupId': 'FG001', 'numSubjects': '1393'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1392'}, {'groupId': 'FG001', 'numSubjects': '1392'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}, {'title': 'Fetuses or Infants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2795'}, {'groupId': 'FG001', 'numSubjects': '2812'}]}, {'type': 'Included in the Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2785'}, {'groupId': 'FG001', 'numSubjects': '2786'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2783'}, {'groupId': 'FG001', 'numSubjects': '2782'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '30'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caesarean Section', 'description': 'delivery by caesarean section\n\nMethod of Delivery: CS or VB'}, {'id': 'BG001', 'title': 'Vaginal Birth', 'description': 'delivery by vaginal birth\n\nMethod of Delivery: CS or VB'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Maternal age >= 30 yr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '632', 'groupId': 'BG000'}, {'value': '632', 'groupId': 'BG001'}, {'value': '1264', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity >= 1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '857', 'groupId': 'BG000'}, {'value': '856', 'groupId': 'BG001'}, {'value': '1713', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous cesarean section', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at randomization', 'classes': [{'title': '<32 wk 0 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '32 wk 0 days to 33 wk 6 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '475', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '952', 'groupId': 'BG002'}]}]}, {'title': '34 wk 0 days to 36 wk 6 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '679', 'groupId': 'BG000'}, {'value': '665', 'groupId': 'BG001'}, {'value': '1344', 'groupId': 'BG002'}]}]}, {'title': '37 wk 0 days to 38 wk 6 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chorionicity at birth', 'classes': [{'title': 'Dichorionic and diamnionic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '961', 'groupId': 'BG000'}, {'value': '970', 'groupId': 'BG001'}, {'value': '1931', 'groupId': 'BG002'}]}]}, {'title': 'Monochorionic and diamnionic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '660', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Chorionicity was determined by means of ultrasonography', 'unitOfMeasure': 'Participants'}, {'title': 'Not in labor at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1392', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2785', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1190', 'groupId': 'BG000'}, {'value': '1159', 'groupId': 'BG001'}, {'value': '2349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data was missing from one woman in the planned cesarean delivery'}, {'title': 'Membranes ruptured at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "National perinatal mortality in mother's country of residence", 'classes': [{'title': '<15 deaths/1000 births', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '724', 'groupId': 'BG000'}, {'value': '730', 'groupId': 'BG001'}, {'value': '1454', 'groupId': 'BG002'}]}]}, {'title': '15-20 deaths/1000 births', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '596', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1187', 'groupId': 'BG002'}]}]}, {'title': '>20 deaths/1000 births', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1393', 'groupId': 'BG000'}, {'value': '1393', 'groupId': 'BG001'}, {'value': '2786', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Countries included in the study that had fewer than 15 deaths per 1000 births were Australia, Belgium, Canada, Chile, Croatia, Estonia, Germany, Greece, Hungary, Israel, the Netherlands, Oman, Poland, Qatar, Romania, Serbia, Spain, the United Kingdom, the United States, and Uruguay; those with 15 to 20 deaths per 1000 births were Argentina, Brazil, and Jamaica; and those with more than 20 deaths per 1000 births were Egypt and Jordan.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2804}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-20', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline Characteristics - Gestational Age at Randomization', 'timeFrame': 'Basline'}, {'measure': 'Baseline Characteristics - Estimated Fetal Weight', 'timeFrame': 'Basline'}, {'measure': 'Other Maternal Outcomes', 'timeFrame': '2 years postpartum', 'description': 'Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum'}, {'measure': 'Other Maternal Outcomes', 'timeFrame': '2 year postpartum', 'description': "Maternal quality of life at 2 years postpartum (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability);"}, {'measure': 'Other Maternal Outcomes', 'timeFrame': '3 months postpartum', 'description': 'Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months'}, {'measure': 'Other Maternal Outcomes', 'timeFrame': '3 months postpartum', 'description': "Maternal quality of life at 3 months (scores were reported using a scale of 0-100 with '0' indicating maximum disability and '100' no disability); Maternal fatigue at 3 months (the scale combines 16 items to produce a Global Fatigue Index (GFI), which can range from 1 (no fatigue) to 50 (severe fatigue)); Maternal depression at 3 months was measured by the Edinburgh Postnatal Depression Scale, which measures how women have been feeling in the previous 7 days, with a score of \\>12 indicating depression (each answer is given a score of 0 to 3 based on the seriousness of the symptom. The total possible maximum depression score is 30). IIQ-7 at 3 months are validated questions about the impact of the incontinence (scores were reported using a scale of 0-100, with '0' indicating no impact at all and '100' greatly impacted)."}], 'primaryOutcomes': [{'measure': 'Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity', 'timeFrame': 'until 28 days after delivery', 'description': 'The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.'}], 'secondaryOutcomes': [{'measure': 'Neonatal Morbidity', 'timeFrame': 'until 28 days after delivery', 'description': 'Neonatal morbidity, excluding death of either twin'}, {'measure': 'Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)', 'timeFrame': '2 years', 'description': 'Neurodevelopmental outcome will be assessed by the Ages and Stages Questionnaire (ASQ). The ASQ is a parent/parental caregiver-administered structured questionnaire that includes questions on 5 domains of development: communication, gross motor skills, fine motor skills, problem-solving skills, and personal-social skills. If the score for any 1 of the 5 domains is below the specific cutoff for the domain, the ASQ was considered abnormal.'}, {'measure': 'Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum', 'timeFrame': '2 years postpartum', 'description': 'The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['twins', 'twin births', 'multiples'], 'conditions': ['Twin Pregnancy']}, 'referencesModule': {'references': [{'pmid': '24088091', 'type': 'BACKGROUND', 'citation': 'Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939.'}, {'pmid': '35398584', 'type': 'DERIVED', 'citation': 'Hochler H, Tevet A, Barg M, Suissa-Cohen Y, Lipschuetz M, Yagel S, Aviram A, Mei-Dan E, Melamed N, Barrett JFR, Fox NS, Walfisch A. Trial of labor of vertex-nonvertex twins following a previous cesarean delivery. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100640. doi: 10.1016/j.ajogmf.2022.100640. Epub 2022 Apr 8.'}, {'pmid': '33203367', 'type': 'DERIVED', 'citation': 'Dougan C, Gotha L, Melamed N, Aviram A, Asztalos EV, Anabusi S, Willan AR, Barrett J, Mei-Dan E. Cesarean delivery or induction of labor in pre-labor twin gestations: a secondary analysis of the twin birth study. BMC Pregnancy Childbirth. 2020 Nov 17;20(1):702. doi: 10.1186/s12884-020-03369-x.'}, {'pmid': '32592694', 'type': 'DERIVED', 'citation': 'Aviram A, Lipworth H, Asztalos EV, Mei-Dan E, Melamed N, Cao X, Zaltz A, Hvidman L, Barrett JFR. Delivery of monochorionic twins: lessons learned from the Twin Birth Study. Am J Obstet Gynecol. 2020 Dec;223(6):916.e1-916.e9. doi: 10.1016/j.ajog.2020.06.048. Epub 2020 Jun 24.'}, {'pmid': '31254526', 'type': 'DERIVED', 'citation': 'Aviram A, Lipworth H, Asztalos EV, Mei-Dan E, Cao X, Melamed N, Zaltz A, Anastasio HB, Berghella V, Barrett JFR. The worst of both worlds-combined deliveries in twin gestations: a subanalysis of the Twin Birth Study, a randomized, controlled, prospective study. Am J Obstet Gynecol. 2019 Oct;221(4):353.e1-353.e7. doi: 10.1016/j.ajog.2019.06.047. Epub 2019 Jun 27.'}, {'pmid': '28061767', 'type': 'DERIVED', 'citation': 'Mei-Dan E, Asztalos EV, Willan AR, Barrett JF. The effect of induction method in twin pregnancies: a secondary analysis for the twin birth study. BMC Pregnancy Childbirth. 2017 Jan 6;17(1):9. doi: 10.1186/s12884-016-1201-8.'}, {'pmid': '26551181', 'type': 'DERIVED', 'citation': 'Melamed N, Wong J, Asztalos E, Rosen H, Okby R, Barrett J. The Likelihood of Change in Fetal Presentation During the Third Trimester in Twin Pregnancies. Obstet Gynecol. 2015 Dec;126(6):1231-1236. doi: 10.1097/AOG.0000000000001128.'}]}, 'descriptionModule': {'briefSummary': 'For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of planned caesarean section (CS) lower the likelihood of death or serious illness, during the first 28 days after birth, compared to a plan for vaginal birth (VB)?', 'detailedDescription': 'For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women at 32 0/7 - 38 6/7 weeks gestation\n2. Estimated fetal weight of each fetus 1500 - 4000 g\n3. Both twins alive at time of randomization\n4. Twin A is in cephalic position\n\nExclusion Criteria:\n\n1. Monoamniotic twins\n2. Lethal fetal anomaly of either fetus\n3. Contraindication to labour or vaginal delivery for either twin\n4. Previous participation in the Twin Birth Study'}, 'identificationModule': {'nctId': 'NCT00187369', 'briefTitle': 'The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'The Twin Birth Study: A Multicentre Randomised Controlled Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins More Than or Equal to 32 Weeks Gestation', 'orgStudyIdInfo': {'id': 'MCT-63164'}, 'secondaryIdInfos': [{'id': 'ISRCTN74420086'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Caesarean Section', 'description': 'delivery by CS', 'interventionNames': ['Procedure: Method of Delivery']}, {'type': 'OTHER', 'label': 'Vaginal Birth', 'description': 'delivery by VB', 'interventionNames': ['Procedure: Method of Delivery']}], 'interventions': [{'name': 'Method of Delivery', 'type': 'PROCEDURE', 'description': 'CS or VB', 'armGroupLabels': ['Caesarean Section', 'Vaginal Birth']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Data Coordinating Centre/SHSC', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jon F Barrett', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SHSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Maternal-Fetal Medicine', 'investigatorFullName': 'Dr Jon Barrett', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}