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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987063
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date November 4, 2013
First Posted Date November 19, 2013
Last Update Posted Date April 19, 2016
Study Start Date February 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 12, 2013)
  • 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
  • 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
  • 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)
  • Duration of neonatal hospitalisation of first twin [ Time Frame: Weeks after birth and before hospital discharge ]
    Duration between birth and hospital discharge
  • Duration of neonatal hospitalisation of second twin [ Time Frame: Weeks after birth and before hospital discharge ]
    Duration between birth and hospital discharge
  • Duration of maternal hospitalisation [ Time Frame: Weeks after birth and before hospital discharge ]
    Duration between delivery and hospital discharge
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population cohort of pregnant woman with twins or triplets or quadruples
Condition Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation
Intervention Not Provided
Study Groups/Cohorts pregnant woman with twins
pregnant woman with twins
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2016)
8979
Original Estimated Enrollment
 (submitted: November 12, 2013)
9000
Actual Study Completion Date December 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987063
Other Study ID Numbers NI12012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: François GOFFINET, MD, PhD APHP, France
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2016