Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation Clinical Trial
Official title:
National Prospective and Comparative Study on the Mode of Delivery of Twins
The purpose of this study is to determine the best obstetrical practices for twin delivery.
Large retrospective cohort studies have reported increased neonatal death and morbidity
associated with vaginal delivery in comparison with cesarean in twin pregnancies. A recent
large international randomized trial, the Twin Birth Study (TBS), showed that planned
cesarean does not significantly decrease or increase the risk of fetal or neonatal death or
serious neonatal morbidity, as compared with planned vaginal delivery in twin pregnancy
between 32 and 39 weeks of gestation with a first twin in cephalic presentation. However,
neither these large retrospective cohort studies, because information regarding delivery
management is lacking, nor the TBS, because of insufficient statistical power, can answer
the question on how to manage vaginal twin deliveries.
The aim of the JUMODA study is first to confirm in France whether planned vaginal delivery
is not associated with increased neonatal risks in comparison with planned caesarean as
shown in the TBS and secondly to determine the best obstetrical practices in case of vaginal
delivery.
Analysis will be performed according to the planned mode of delivery (planned cesarean or
planned vaginal delivery) and stratified according to:
1. Twin rank: second or first twin
2. Gestational age: before 28 weeks of gestation, before 32 weeks, after 32 weeks, and
after 35 weeks
3. In the whole population and in low risk populations.
For women delivering vaginally, analysis will be stratified according to:
4. Second twin presentation: vertex or non vertex
5. Obstetrical manoeuvres: none, internal cephalic version, external cephalic version,
total breech extraction
;
Observational Model: Cohort, Time Perspective: Prospective