Pregnant With ComplicationCOGEMNCT05144321
Twin Pregnancy Cohort
An observational study of Pregnant With Complication and Twin Pregnancy With Antenatal Problem, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant With Complication, Twin Pregnancy With Antenatal Problem
- What is being tested?
- Impact of environment upon obstetrical and neonatal and maternal adverse outcome
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women delivering a twin pregnancy
Who may be able to join
- Pregnant women
- Delivery of a twin pregnancy
- Gestational age >25 weeks
- Age >18 years
Who cannot join
- Singleton pregnancy
- Miscarriage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Impact of environment upon obstetrical, neonatal and maternal adverse outcome
- Keywords
- Pregnant women, Environment, Adverse outcome, Age >18 years, Gestational age >25 weeks, Delivery of a twin pregnancy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of environment upon obstetricalOther
Impact of environment upon obstetrical
neonatal and maternal adverse outcomeOther
neonatal and maternal adverse outcome
| Study group | Role | What they receive |
|---|---|---|
| All pregnant women delivering a twin pregnancy | All pregnant women delivering a twin pregnancy Receives: Other: Impact of environment upon obstetrical; Other: neonatal and maternal adverse outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal adverse outcome
Pomaternal adverse outcome
Measured: day 1
Secondary outcomes (2)
Neonatal adverse outcome
Neonatal adverse outcome
Measured: day 1
Obstetrical adverse outcome
Obstetrical adverse outcome
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant With ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144321
- Sponsor's protocol ID
- RECHMPL21_0703
- Acronym
- COGEM
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM
- ClinicalTrials.gov ID
- NCT05144321
- Acronym / sponsor ID
- COGEM / RECHMPL21_0703
- Keywords
- Pregnant women, Environment, Adverse outcome, Age >18 years, Gestational age >25 weeks, Delivery of a twin pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All pregnant women delivering a twin pregnancy | – | Other: Impact of environment upon obstetrical, Other: neonatal and maternal adverse outcomeAll pregnant women delivering a twin pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women delivering a twin pregnancy
Key inclusion criteria (4 listed)
- Pregnant women
- Delivery of a twin pregnancy
- Gestational age >25 weeks
- Age >18 years
Key exclusion criteria (2 listed)
- Singleton pregnancy
- Miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of environment upon obstetricalImpact of environment upon obstetrical | Other | All pregnant women delivering a twin pregnancy |
| neonatal and maternal adverse outcomeneonatal and maternal adverse outcome | Other | All pregnant women delivering a twin pregnancy |
Primary outcome
maternal adverse outcome
Time frame: day 1
Pomaternal adverse outcome
2 secondary outcomes
Neonatal adverse outcome
Time frame: day 1
Obstetrical adverse outcome
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent FUCHS, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant With Complication and Twin Pregnancy With Antenatal Problem, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal adverse outcome (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.