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

NCT ID: NCT01987063

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8979 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pregnant woman with twins

pregnant woman with twins

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

François GOFFINET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Robert Debré - APHP

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24088091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17436454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16045531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12411358 (View on PubMed)

Korb D, Schmitz T, Seco A, Goffinet F, Deneux-Tharaux C; JUmeaux MODe d'Accouchement (JUMODA) study group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Risk factors and high-risk subgroups of severe acute maternal morbidity in twin pregnancy: A population-based study. PLoS One. 2020 Feb 28;15(2):e0229612. doi: 10.1371/journal.pone.0229612. eCollection 2020.

Reference Type RESULT
PMID: 32109258 (View on PubMed)

Korb D, Deneux-Tharaux C, Seco A, Goffinet F, Schmitz T; JUmeaux MODe d'Accouchement (JUMODA) study group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Risk of Severe Acute Maternal Morbidity According to Planned Mode of Delivery in Twin Pregnancies. Obstet Gynecol. 2018 Sep;132(3):647-655. doi: 10.1097/AOG.0000000000002788.

Reference Type RESULT
PMID: 30095775 (View on PubMed)

Schmitz T, Prunet C, Azria E, Bohec C, Bongain A, Chabanier P, D'Ercole C, Deruelle P, De Tayrac R, Dreyfus M, Dupont C, Gondry J, Graesslin O, Kayem G, Langer B, Marpeau L, Morel O, Parant O, Perrotin F, Pierre F, Poulain P, Riethmuller D, Rozenberg P, Rudigoz RC, Sagot P, Senat MV, Sentilhes L, Vayssiere C, Venditelli F, Verspyck E, Winer N, Lecomte-Raclet L, Ancel PY, Goffinet F; JUmeaux MODe d'Accouchement (JUMODA) Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Association Between Planned Cesarean Delivery and Neonatal Mortality and Morbidity in Twin Pregnancies. Obstet Gynecol. 2017 Jun;129(6):986-995. doi: 10.1097/AOG.0000000000002048.

Reference Type RESULT
PMID: 28486364 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NI12012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outpatient Birth: Pilot Study
NCT03815227 COMPLETED NA
Cerclage for Twins With Short Cervix
NCT03077633 WITHDRAWN PHASE2/PHASE3
Cerclage for Short Cervix in Twins
NCT02912390 TERMINATED NA