Twin Pregnancy Clinical Trial
Official title:
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
Verified date | May 2020 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)?
Status | Completed |
Enrollment | 2804 |
Est. completion date | October 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Women at 32 0/7 - 38 6/7 weeks gestation 2. Estimated fetal weight of each fetus 1500 - 4000 g 3. Both twins alive at time of randomization 4. Twin A is in cephalic position Exclusion Criteria: 1. Monoamniotic twins 2. Lethal fetal anomaly of either fetus 3. Contraindication to labour or vaginal delivery for either twin 4. Previous participation in the Twin Birth Study |
Country | Name | City | State |
---|---|---|---|
Canada | Data Coordinating Centre/SHSC | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Institutes of Health Research (CIHR) |
Canada,
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. Erratum in: N Engl J Med. 2013 Dec 12;369(24):2364. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Baseline Characteristics - Gestational Age at Randomization | Basline | ||
Other | Baseline Characteristics - Estimated Fetal Weight | Basline | ||
Other | Other Maternal Outcomes | Maternal depression at 2 years postpartum; Breastfeeding at 2 years postpartum | 2 years postpartum | |
Other | Other Maternal Outcomes | 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); | 2 year postpartum | |
Other | Other Maternal Outcomes | Maternal depression at 3 months; Problematic urinary or faecal/flatal incontinence at 3 months; Breastfeeding at 3 months | 3 months postpartum | |
Other | Other Maternal Outcomes | 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). | 3 months postpartum | |
Primary | Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity | The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity. | until 28 days after delivery | |
Secondary | Neonatal Morbidity | Neonatal morbidity, excluding death of either twin | until 28 days after delivery | |
Secondary | Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) | 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. | 2 years | |
Secondary | Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum | The occurrence of problematic urinary, faecal/flatal incontinence at 2 years following the birth will be determined by structured questionnaire | 2 years postpartum |
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