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

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris
The purpose of this study is to determine the best obstetrical practices for twin delivery.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

8979

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Robert Debré - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

cohort of pregnant woman with twins or triplets or quadruples

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pregnant woman with twins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation
Time Frame: 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.
72 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation
Time Frame: 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
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
Time Frame: 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
Day 28 after birth
Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation
Time Frame: 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)
Weeks after birth and before hospital discharge
Duration of neonatal hospitalisation of first twin
Time Frame: Weeks after birth and before hospital discharge
Duration between birth and hospital discharge
Weeks after birth and before hospital discharge
Duration of neonatal hospitalisation of second twin
Time Frame: Weeks after birth and before hospital discharge
Duration between birth and hospital discharge
Weeks after birth and before hospital discharge
Duration of maternal hospitalisation
Time Frame: Weeks after birth and before hospital discharge
Duration between delivery and hospital discharge
Weeks after birth and before hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: François GOFFINET, MD, PhD, APHP, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimated)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NI12012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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