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Pregnant Woman With Twins After 22 Weeks 0 Days of GestationJUMODANCT01987063

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

An observational study of Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age, women only
How many people
8,979 participants
Where
1 siteFrance
Study dates
Feb 2014to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: cohort of pregnant woman with twins or triplets or quadruples

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Robert Debré - APHP

    Paris, 75019

Other trials in France

About this study

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

Read the 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
Keywords
Twin delivery, Planned vaginal delivery, Planned cesarean delivery, Total breech extraction, Internal cephalic version, External cephalic version

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01987063
Study groupRoleWhat they receive
pregnant woman with twinspregnant woman with twins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation

    • 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.

    Measured: 72 hours after birth

Secondary outcomes (6)

  1. 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 first twin after 32 weeks 0 days of gestation

    Measured: Day 28 after birth

  2. Composite measure of intrapartum and neonatal death and serious morbidity of the second 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

    Measured: Day 28 after birth

  3. Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation

    • 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)

    Measured: Weeks after birth and before hospital discharge

  4. Duration of neonatal hospitalisation of first twin

    Duration between birth and hospital discharge

    Measured: Weeks after birth and before hospital discharge

  5. Duration of neonatal hospitalisation of second twin

    Duration between birth and hospital discharge

    Measured: Weeks after birth and before hospital discharge

  6. Duration of maternal hospitalisation

    Duration between delivery and hospital discharge

    Measured: Weeks after birth and before hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8,979 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987063
Sponsor's protocol ID
NI12012
Acronym
JUMODA
Status last verified
Oct 2025
First submitted
4 Nov 2013
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24088091

  • 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.

    PubMed 17436454

  • 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.

    PubMed 16045531

  • 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.

    PubMed 12411358

  • 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.

    PubMed 32109258

  • 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.

    PubMed 30095775

  • 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.

    PubMed 28486364

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987063, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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