N/A
N=2,804
The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins
Twin Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00187369 ↗Enrolled (actual)
2,804
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity — 60; 52; 24; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Method of Delivery (Procedure)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity |
60; 52; 24; 17; 13; 9 | — |
| SECONDARY Neonatal Morbidity |
0; 4; 1; 1; 0; 1 | — |
| SECONDARY Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth) |
24; 17; 11; 6; 104; 110 | — |
| SECONDARY Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum |
187; 250; 93; 140; 47; 68 | — |
Summary
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)?
Eligibility Criteria
Inclusion Criteria
- Women at 32 0/7 - 38 6/7 weeks gestation
- Estimated fetal weight of each fetus 1500 - 4000 g
- Both twins alive at time of randomization
- Twin A is in cephalic position
Exclusion Criteria
- Monoamniotic twins
- Lethal fetal anomaly of either fetus
- Contraindication to labour or vaginal delivery for either twin
- Previous participation in the Twin Birth Study
Data sourced from ClinicalTrials.gov (NCT00187369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.