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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01987063
First received: November 4, 2013
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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


Condition
Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Prospective and Comparative Study on the Mode of Delivery of Twins

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 28 after birth ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks after birth and before hospital discharge ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: Weeks after birth and before hospital discharge ] [ Designated as safety issue: No ]
    Duration between birth and hospital discharge

  • Duration of neonatal hospitalisation of second twin [ Time Frame: Weeks after birth and before hospital discharge ] [ Designated as safety issue: No ]
    Duration between birth and hospital discharge

  • Duration of maternal hospitalisation [ Time Frame: Weeks after birth and before hospital discharge ] [ Designated as safety issue: No ]
    Duration between delivery and hospital discharge


Estimated Enrollment: 9000
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
pregnant woman with twins
pregnant woman with twins

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cohort of pregnant woman with twins

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987063

Contacts
Contact: Thomas SCHMITZ, MD, PhD 00 33 1 40 03 20 00 thomas.schmitz@rdb.aphp.fr
Contact: Laurence Lecomte, PhD 00 33 1 58 41 35 45 laurence.lecomte@cch.aphp.fr

Locations
France
Hôpital Robert Debré - APHP Recruiting
Paris, France, 75019
Contact: Thomas SCHMITZ, MD, PhD    00 33 1 40 03 20 00    thomas.schmitz@rdb.aphp.fr   
Contact: Laurence Lecomte, PhD    00 33 1 58 41 35 45    laurence.lecomte@cch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: François GOFFINET, MD, PhD APHP, France
  More Information