COGEM: Twin Pregnancy Cohort

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05144321
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnant With Complication; Twin Pregnancy With Antenatal Problem	Other: Impact of environment upon obstetrical; Other: neonatal and maternal adverse outcome

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
All pregnant women delivering a twin pregnancy All pregnant women delivering a twin pregnancy	Other: Impact of environment upon obstetrical; Impact of environment upon obstetrical; Other: neonatal and maternal adverse outcome; neonatal and maternal adverse outcome

Outcome Measures

Primary Outcome Measures

1. maternal adverse outcome [day 1]

   Pomaternal adverse outcome

Secondary Outcome Measures

1. Neonatal adverse outcome [day 1]

   Neonatal adverse outcome

2. Obstetrical adverse outcome [day 1]

   Obstetrical adverse outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Pregnant women

• Delivery of a twin pregnancy

• Gestational age >25 weeks

• Age >18 years

Exclusion criteria:

• Singleton pregnancy

• Miscarriage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT05144321
• Other Study ID Numbers: RECHMPL21_0703
• First Posted: Dec 3, 2021
• Last Update Posted: Dec 3, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Pregnant women; Environment; Adverse outcome; Age >18 years; Gestational age >25 weeks; Delivery of a twin pregnancy
• Additional relevant MeSH terms: Pregnancy Complications

Study Results

No Results Posted as of Dec 3, 2021