Twin Pregnancy Cohort | NCT05144321

Studies
Twin Pregnancy Cohort

NCT05144321

Sponsor

University Hospital, Montpellier

Status

Active, not recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Pregnant With Complication
Twin Pregnancy With Antenatal Problem

Interventions

Impact of environment upon obstetrical
neonatal and maternal adverse outcome

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2029Estimated

First Submitted Date

Nov 24, 2021

First Submission Date that Met QC Criteria

Nov 24, 2021

First Posted Date

Dec 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All pregnant women delivering a twin pregnancy		All pregnant women delivering a twin pregnancy	Other: Impact of environment upon obstetrical Other: neonatal and maternal adverse outcome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impact of environment upon obstetrical	Other	Impact of environment upon obstetrical	All pregnant women delivering a twin pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maternal adverse outcome	Pomaternal adverse outcome	day 1

Secondary Outcomes

Measure	Description	Time Frame
Neonatal adverse outcome	Neonatal adverse outcome	day 1
Obstetrical adverse outcome	Obstetrical adverse outcome	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Pregnant women
Delivery of a twin pregnancy
Gestational age >25 weeks
Age >18 years

Exclusion criteria:

Singleton pregnancy
Miscarriage

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women delivering a twin pregnancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florent FUCHS, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier	Montpellier	34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided