Clinical trial NCT01987063: National Prospective and Comparative Study on the Mode of Delivery of Twins
Official title: National Prospective and Comparative Study on the Mode of Delivery of Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation
Keywords: Twin delivery
Planned vaginal delivery
Planned cesarean delivery
Total breech extraction
Internal cephalic version
External cephalic version
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 8979
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohort of pregnant woman with twins or triplets or quadruples

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
timeFrame: 72 hours after birth
Secondary outcomes:
measure: Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation
timeFrame: Day 28 after birth
measure: Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
timeFrame: Day 28 after birth
measure: Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation
timeFrame: Weeks after birth and before hospital discharge
measure: Duration of neonatal hospitalisation of first twin
timeFrame: Weeks after birth and before hospital discharge
measure: Duration of neonatal hospitalisation of second twin
timeFrame: Weeks after birth and before hospital discharge
measure: Duration of maternal hospitalisation
timeFrame: Weeks after birth and before hospital discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré - APHP
Study officials:
affiliation: APHP, France
name: François GOFFINET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Smith GC. Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762. doi: 10.1136/bmj.39176.426424.3a. No abstract available.
citation: Smith GC, Shah I, White IR, Pell JP, Dobbie R. Mode of delivery and the risk of delivery-related perinatal death among twins at term: a retrospective cohort study of 8073 births. BJOG. 2005 Aug;112(8):1139-44. doi: 10.1111/j.1471-0528.2005.00631.x.
citation: Smith GC, Pell JP, Dobbie R. Birth order, gestational age, and risk of delivery related perinatal death in twins: retrospective cohort study. BMJ. 2002 Nov 2;325(7371):1004. doi: 10.1136/bmj.325.7371.1004.