- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05144321
Twin Pregnancy Cohort (COGEM)
Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM
The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.
The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Montpellier
-
Montpellier, Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Pregnant women
- Delivery of a twin pregnancy
- Gestational age >25 weeks
- Age >18 years
Exclusion criteria:
- Singleton pregnancy
- Miscarriage
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
All pregnant women delivering a twin pregnancy
|
Impact of environment upon obstetrical
neonatal and maternal adverse outcome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maternal adverse outcome
Time Frame: day 1
|
Pomaternal adverse outcome
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal adverse outcome
Time Frame: day 1
|
Neonatal adverse outcome
|
day 1
|
|
Obstetrical adverse outcome
Time Frame: day 1
|
Obstetrical adverse outcome
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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