NCT05144321

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Nov 2021Dec 2026

Study Start

First participant enrolled

November 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

5.1 years

First QC Date

November 24, 2021

Last Update Submit

January 16, 2025

Conditions

Pregnant With ComplicationTwin Pregnancy With Antenatal Problem

Keywords

Pregnant womenEnvironmentAdverse outcomeAge >18 yearsGestational age >25 weeksDelivery of a twin pregnancy

Outcome Measures

Primary Outcomes (1)

  • maternal adverse outcome

    Pomaternal adverse outcome

    day 1

Secondary Outcomes (2)

  • Neonatal adverse outcome

    day 1

  • Obstetrical adverse outcome

    day 1

Study Arms (1)

All pregnant women delivering a twin pregnancy

All pregnant women delivering a twin pregnancy

Other: Impact of environment upon obstetricalOther: neonatal and maternal adverse outcome

Interventions

Impact of environment upon obstetricalOTHER

Impact of environment upon obstetrical

All pregnant women delivering a twin pregnancy
neonatal and maternal adverse outcomeOTHER

neonatal and maternal adverse outcome

All pregnant women delivering a twin pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women delivering a twin pregnancy

You may qualify if:

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

You may not qualify if:

  • Singleton pregnancy
  • Miscarriage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Florent FUCHS, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 3, 2021

Study Start

November 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

FR(1)