Prospective Twin Pregnancy Cohort at Montpellier University Hospital (NCT07408973) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Twin Pregnancy Cohort at Montpellier University Hospital
360 participantsStarted 2026-12
Plain-language summary
This prospective observational cohort study aims to investigate the impact of the maternal and early-life exposome on neonatal and early childhood health outcomes in twin pregnancies followed at University Hospital of Montpellier (France). Grounded in the Developmental Origins of Health and Disease (DOHaD) framework, the study focuses on how environmental, biological, and lifestyle exposures during pregnancy and the first year of life influence fetal growth, neonatal health, and early development.
A total of 120 women with monochorionic or dichorionic twin pregnancies and their 240 children will be included. Maternal exposome assessment includes air pollution exposure, lifestyle, diet, medical history, and biological measurements. Neonatal outcomes, including abnormal birth weight, will be evaluated at birth, and children will be followed until one year of age to assess growth, health events, and developmental outcomes. Biological samples collected at different times during the study will allow the assessment of chemical exposures and epigenetic markers. This study aims to generate original French twin pregnancy data and to improve understanding of environmental determinants of early-life health.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Mother's inclusion Criteria:
* Patient of legal age (≥ 18 years)
* Patient pregnant with a twin pregnancy ≥ 25 weeks of gestation
* Pregnancy initially twin, triplet, or quadruplet, progressing to a twin pregnancy after spontaneous or medical embryo reduction, or after selective termination of pregnancy
* Delivery planned at Montpellier University Hospital
Twins' inclusion Criteria:
* Twins born in a twin pregnancy ≥ 25 weeks of gestation
Mother's exclusion Criteria:
* Pregnant woman with at least one fetus presenting with a chromosomal or genetic abnormality or a polymalformative syndrome, and for whom early postnatal death is anticipated.
* Planned travel preventing the study from being completed
* Failure to obtain informed and written consent from the patient for participation in the study and the collection of biological samples
* Patient unable to read and/or write French
* Patient unable to understand and/or speak French
* Patient not benefiting from a national health insurance scheme
* Person under legal protection, guardianship or curatorship
* Person participating in other interventional research study
Twins' exclusion Criteria:
* Mother's absence from or withdrawal from the study
* Birth in a facility other than Montpellier University Hospital
* One or two children under guardianship
* Lack of informed and written consent from legal representatives
* One of the two fetuses is expected to die
* Lack of informed and written consent from the prospective parent(…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on twin pregnancies specifically — given that I'm carrying twins, does my doctor think my situation fits what this cohort is looking for, and what would joining actually involve for me day-to-day?
2The trial is measuring something called the 'extern exposome' and 'intern exposome' — can my doctor explain what those terms mean in plain language, and what kinds of data or samples I would need to provide throughout my pregnancy?
3Since this study is looking at abnormal newborn weight as a key outcome, would participating mean my babies get any extra monitoring, or is this purely an observational study where researchers are just collecting data without changing my care?
4The trial isn't recruiting yet — if I'm interested, how far along in my pregnancy can I be before it's too late to enroll, and is my doctor aware of when Montpellier University Hospital plans to open enrollment?
5Since this is an observational cohort rather than a treatment trial, my doctor and I won't be weighing an experimental therapy — but are there any privacy or logistical concerns I should think about before agreeing to share detailed personal health and environmental exposure data?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal extern exposome
Timeframe: From two years before pregnancy until delivery
2
Maternal intern exposome
Timeframe: From two years before pregnancy until delivery