National Prospective and Comparative Study on the Mode of Delivery of Twins (JUMODA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation

Study type: Observational

Funder types: Other

Identifiers

NCT01987063

NI12012

Details and patient eligibility

About

The purpose of this study is to determine the best obstetrical practices for twin delivery.

Full description

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

Enrollment: 8,979 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients delivering twins after 22 weeks and 0 days gestation in the participating maternities will be included in the study.

Exclusion criteria

• Patients who expressed opposition to the use of personal medical data or medical data from their children for this research will not be included in the study

Trial design

8,979 participants in 1 patient group

pregnant woman with twins

Description:

pregnant woman with twins