National Prospective and Comparative Study on the Mode of Delivery of Twins

Completed

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

• Registration Number: NCT01987063
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2014-02
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8979

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation	72 hours after birth	* Intrapartum fetal death; * Neonatal mortality; * Apgar score lower than 4 at 5 minutes; * Neonatal trauma (fracture of long bones or skull, subdural hematoma, brachial plexus elongation, phrenic or facial paralysis, injury of the spinal cord; * Abnormal level of consciousness (coma, stupor, abnormal response to pain); * Intubation longer than 24 hours within the first 72 hours of life, two or more episodes of neonatal convulsions in the first 72 hours of life; * Proved neonatal infection; * Bronchopulmonary dysplasia; * Necrotizing enterocolitis; * Intraventricular hemorrhage grade III or IV; * Periventricular leukomalacia.

Secondary Outcome Measures

Name	Time	Method
Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation	Day 28 after birth	Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation
Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation	Day 28 after birth	Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation	Weeks after birth and before hospital discharge	* Maternal death; * Severe postpartum hemorrhage (PPH) defined as PPH requiring transfusion, embolisation, surgery, intensive care unit; * Pulmonary embolism, deep venous thrombosis; * Cerebrovascular accident; * Postpartum psychosis; * Severe thrombopenia (\<50 000); * Severe anemia (\<7g/dL); * Renal failure (oliguria \<500 mL/24h or creatinin\>135 mmol/L); * Maternal transfer in ICU; * Laparotomy; * Intraoperative injury to the bowel, ureter or bladder requiring repair; * Vulvar or perineal hematoma requiring evacuation; * Third and fourth degree perineal lacerations; * Systemic infection (positive blood culture or temperature \> 38.5 °C on two or more occasions at least 24h apart)
Duration of neonatal hospitalisation of first twin	Weeks after birth and before hospital discharge	Duration between birth and hospital discharge
Duration of neonatal hospitalisation of second twin	Weeks after birth and before hospital discharge	Duration between birth and hospital discharge
Duration of maternal hospitalisation	Weeks after birth and before hospital discharge	Duration between delivery and hospital discharge

Trial Locations

Locations (1)

Hôpital Robert Debré - APHP; 🇫🇷 Paris, France