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PregnancyCOGEMNCT07408973

Prospective Twin Pregnancy Cohort at Montpellier University Hospital

An observational study of Pregnancy and Twin, run by University Hospital, Montpellier.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pregnancy, Twin
What is being tested?
Biological samples from the mother and Biological samples from the twins
How many people
360 participants
Where
No sites listed yet
Study dates
Dec 2026to 1 Dec 2030
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any dichorionic or monochorionic twin pregnancy of more than 25 weeks' gestation, monitored at the University Hospital of Montpellier.

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(s) for participation in the study and the collection of biological samples
  • Parents unable to read and/or write French
  • Parents not understanding and/or speaking French

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Florent FUCHS, MD, PhD contact

+334 67 33 09 80

f-fuchs@chu-montpellier.fr

Davide CAIMMI, MD, PhD contact

+334 67 33 61 03

dp-caimmi@chu-montpellier.fr

About this study

Official title: Twin Pregnancy Cohort at Montpellier University Hospital for a Study of the Impact of the Exposome: Pilot Study

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.

Read the detailed description

Introduction:

Over the past two decades, growing epidemiological evidence in humans and experimental studies in animals have supported the concept of the Developmental Origins of Health and Disease (DOHaD), initially proposed by Barker. This hypothesis suggests that environmental and maternal conditions during critical periods of development-particularly the first 1,000 days of life, from conception to early childhood-can induce long-term effects on organogenesis, metabolic pathways, and physiological functions, ultimately influencing physical and mental health throughout life.

In parallel, the concept of the exposome, introduced by Wild in 2005, aims to comprehensively characterize all environmental exposures (chemical, physical, biological, behavioral, and socioeconomic) encountered by an individual from conception onwards. Twin pregnancies represent a particularly valuable model for exposome research, as they allow the study of shared and differential exposures within the same intrauterine environment. Establishing a large French cohort of twin pregnancies is therefore essential to generate national data and to investigate the impact of environmental exposures on pregnancy outcomes, neonatal health, and early childhood development.

Primary Aim:

Assess the impact of maternal exposome during twin pregnancies followed at Montpellier University Hospital on the occurrence of abnormal neonatal birth weight (small for gestational age) at birth.

Secondary Aims:

  • Evaluate the impact of maternal exposome on neonatal abnormalities at birth and on child health outcomes during the first year of life.
  • Assess the association between maternal exposome and the occurrence of obstetric complications.
  • Compare outcomes between twins from monochorionic (monozygotic) and dichorionic pregnancies (dizygotic, different-sex twins), focusing on:

The impact of maternal exposome during pregnancy on child health outcomes. The impact of the child's own exposome on health outcomes during the first year of life.

Methods:

This is a prospective observational cohort study including women with twin pregnancies (monochorionic or dichorionic) of at least 25 weeks of gestation, followed and delivering at University Hospital of Montpellier (France). A total of 120 pregnant women and their 240 twin children will be enrolled.

Maternal data will be collected during pregnancy through electronic questionnaires and medical records, including sociodemographic characteristics, medical and obstetric history, lifestyle, diet, and environmental exposures. Maternal exposome assessment includes long-term exposure to ambient air pollutants from two years before pregnancy and throughout gestation, as well as biological measurements such as urinary lead levels at 25 weeks of gestation.

At delivery, biological samples will be collected from the mother, placenta, and umbilical cord (blood and tissue). Neonatal data will include anthropometric measurements and clinical outcomes at birth. The child exposome will be assessed through environmental exposure data during pregnancy and the first year of life, questionnaires on lifestyle and environment, and biological analyses including exposure to PFAS, heavy metals, and genomic/epigenetic markers from cord blood and tissue samples.

Conditions
Pregnancy, Twin
Being tested
Biological samples from the mother, Biological samples from the twins
Keywords
Exposome, Air Pollutants, Lead, Diet, Food, and Nutrition, Healthy Lifestyle, Obstetric Labor Complications, Children Health
Medical subject headings
Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological samples from the motherOther

    During pregnancy, the research team collects:

    • 15 ml of urine from the expectant mother.

    Immediately after delivery, the research team collects:

    • 10 ml of peripheral blood from the mother
    • One or two 2 cm x 2 cm pieces of placenta, depending on the type of pregnancy
    • 12 ml of cord blood for each twin
    • A 5 cm fragment of cord tissue for each twin
  • Biological samples from the twinsOther

    The day after delivery, the reserch team collects:

    • A meconium sample from each twin

    At 6 months and 1 year of age, the parents collect:

    • A stool sample from each twin
Study groups in NCT07408973
Study groupRoleWhat they receive
Women pregnant with twinsNot described
Receives: Other: Biological samples from the mother
Twins newbornsNot described
Receives: Other: Biological samples from the twins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal extern exposome

    Exposure to air pollutants (NO₂, PM₂.₅, O₃, VOCs) during the two years prior to and during pregnancy: these values will be derived from the Chimera model, and an area under the exposure curve will be calculated.

    The level of exposure will be calculated based on the mother's home addresses during the two years prior to inclusion, at the time of inclusion, and based on her work addresses during pregnancy if she worked for more than four months during pregnancy.

    These data will be assessed individually and incorporated into a statistical model.

    Data from the patient follow-up log, data from questionnaires:

    • Environment, general health, lifestyle, and diet.
    • Obstetric, medical, and surgical history, current pregnancy. These data will be assessed individually and incorporated into a statistical model.

    Measured: From two years before pregnancy until delivery

  2. Maternal intern exposome

    Amount of lead in urine at 25 weeks of gestation. Lead will be measured by Montpellier University Hospital in a urine sample taken during the sixth month of pregnancy (inclusion) using ICP-Ms.

    These data will be assessed individually and incorporated into a statistical model.

    Measured: From two years before pregnancy until delivery

  3. Abnormal newborn weight

    Growth retardation: Abnormal birth weight (in kg) for at least one of the two children (< 3rd percentile according to the Olsen curve).

    Measured: At childbirth

Secondary outcomes (5)
  1. Abnormalities in children

    • Occurrence of one or more altered anthropometric characteristics (outside reference values) at birth: fetal macrosomia, abnormal height, abnormal head circumference.
    • Occurrence of one or more altered anthropometric characteristics (outside reference values) at D+15, 1, 3, 6, 8, 10 months and 1 year: abnormal weight (<3rd or >97th percentile, Olsen curve), abnormal height (<5th or >95th percentile), abnormal head circumference (<5th or >95th percentile).
    • Occurrence of a serious health problem at birth or during the first year of life.
    • Knowledge of occurrence of one or more of the following conditions during the first year: ENT, respiratory, gastroenterological, dermatological conditions, recognized atopy/allergies, early neurodevelopmental disorder.

    All these data will be assessed individually and incorporated into a statistical model.

    Measured: From childbirth to the twins' first birthday

  2. Obstetric complications

    Occurrence of at least one of the obstetric complications listed in the patient follow-up record.

    Measured: At childbirth

  3. Comparison of the Twins

    • Type of pregnancy from which the twins originate: monochorionic (monoamniotic or biamniotic) or dichorionic.
    • Sex of twins: 2 girls, or 2 boys, or 1 girl and 1 boy

    Measured: At childbirth

  4. Children's extern exposome

    Exposure to air pollutants (NO2, PM2.5, O3, VOCs) throughout pregnancy and during the first year of life: these values will be derived from the Chimera model, and an area under the exposure curve will be calculated.

    The level of exposure will be determined based on the mother's personal and professional addresses during pregnancy and the first year of the children's lives.

    These data will be assessed individually and incorporated into a statistical model.

    Data from the patient follow-up log, data from questionnaires:

    • Environment, lifestyle, diet, treatments received, games and care. These data will be assessed individually and incorporated into a statistical model.

    Measured: From childbirth to the twins' first birthday

  5. Children's intern exposome

    • Exposure to PFAS (per- and polyfluoroalkyl substances) substances can be measured using a piece of umbilical cord taken at birth. The measurement of PFAS in a piece of umbilical cord will be outsourced to a competent laboratory. The PFAS will be extracted from the tissue, then separated and finally quantified using a highly accurate analytical technique.

    These data will be assessed individually and incorporated into a statistical model.

    • Exposure to heavy metals can be measured using a sample of umbilical cord blood taken at birth. The measurement of heavy metals will be entrusted to a competent laboratory. The elements (lead, manganese, copper, zinc, mercury, cadmium, arsenic, selenium) present in the blood are measured by inductively coupled plasma mass spectrometry (ICP-MSMS) after being mineralised (internal method ESS_ANA_PT_641).

    These data will be assessed individually and incorporated into a statistical model.

    Measured: From childbirth to the twins' first birthday

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study startDec 2026 (estimated)
  3. Primary completion1 Mar 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

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
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408973
Sponsor's protocol ID
RECHMPL23_0476
Other IDs
2024-A02160-47
Acronym
COGEM
Status last verified
Jun 2026
First submitted
22 Jan 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Publications

  • Robinson R. The fetal origins of adult disease. BMJ. 2001 Feb 17;322(7283):375-6. doi: 10.1136/bmj.322.7283.375. No abstract available.

    PubMed 11179140
  • Kozyrskyj AL, Bahreinian S, Azad MB. Early life exposures: impact on asthma and allergic disease. Curr Opin Allergy Clin Immunol. 2011 Oct;11(5):400-6. doi: 10.1097/ACI.0b013e328349b166.

    PubMed 21772139
  • Wild CP. Complementing the genome with an "exposome": the outstanding challenge of environmental exposure measurement in molecular epidemiology. Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1847-50. doi: 10.1158/1055-9965.EPI-05-0456. No abstract available.

    PubMed 16103423
  • Gordon H, Blad W, Trier Moller F, Orchard T, Steel A, Trevelyan G, Ng S, Harbord M. UK IBD Twin Registry: Concordance and Environmental Risk Factors of Twins with IBD. Dig Dis Sci. 2022 Jun;67(6):2444-2450. doi: 10.1007/s10620-021-07080-5. Epub 2021 Jun 7.

    PubMed 34097167
  • Southwest Thames Obstetric Research Collaborative (STORK). Prospective risk of late stillbirth in monochorionic twins: a regional cohort study. Ultrasound Obstet Gynecol. 2012 May;39(5):500-4. doi: 10.1002/uog.11110. Epub 2012 Mar 7.

    PubMed 22302586
  • Garne E, Andersen HJ. The impact of multiple pregnancies and malformations on perinatal mortality. J Perinat Med. 2004;32(3):215-9. doi: 10.1515/JPM.2004.040.

    PubMed 15188793
  • Bricker L. Optimal antenatal care for twin and triplet pregnancy: the evidence base. Best Pract Res Clin Obstet Gynaecol. 2014 Feb;28(2):305-17. doi: 10.1016/j.bpobgyn.2013.12.006. Epub 2013 Dec 17.

    PubMed 24412490
  • Campbell DM, MacGillivray I. Preeclampsia in twin pregnancies: incidence and outcome. Hypertens Pregnancy. 1999;18(3):197-207. doi: 10.3109/10641959909016193.

    PubMed 10586523
  • Schwartz DB, Daoud Y, Zazula P, Goyert G, Bronsteen R, Wright D, Copes J. Gestational diabetes mellitus: metabolic and blood glucose parameters in singleton versus twin pregnancies. Am J Obstet Gynecol. 1999 Oct;181(4):912-4. doi: 10.1016/s0002-9378(99)70324-8.

    PubMed 10521752
  • Tang HHF, Teo SM, Sly PD, Holt PG, Inouye M. The intersect of genetics, environment, and microbiota in asthma-perspectives and challenges. J Allergy Clin Immunol. 2021 Mar;147(3):781-793. doi: 10.1016/j.jaci.2020.08.026.

    PubMed 33678251
  • Delvert R, Ghozal M, Adel-Patient K, Kadawathagedara M, Heude B, Charles MA, Annesi-Maesano I, Tafflet M, Leynaert B, Varraso R, de Lauzon-Guillain B, Bedard A. Maternal Diet Quality during Pregnancy and Allergic and Respiratory Multimorbidity Clusters in Children from the EDEN Mother-Child Cohort. Nutrients. 2022 Dec 28;15(1):146. doi: 10.3390/nu15010146.

    PubMed 36615802
  • Mensink-Bout SM, van Meel ER, de Jongste JC, Annesi-Maesano I, Aubert AM, Bernard JY, Chen LW, Cooper C, Crozier SR, Hanke W, Harvey NC, Hebert JR, Heude B, Jerzynska J, Kelleher CC, Mehegan J, McAuliffe FM, Phillips CM, Polanska K, Relton CL, Shivappa N, Suderman M, Jaddoe VWV, Duijts L. Maternal diet in pregnancy and child's respiratory outcomes: an individual participant data meta-analysis of 18 000 children. Eur Respir J. 2022 Apr 21;59(4):2101315. doi: 10.1183/13993003.01315-2021. Print 2022 Apr.

    PubMed 34503987
  • Collado-Soler R, Alferez-Pastor M, Torres FL, Trigueros R, Aguilar-Parra JM, Navarro N. A Systematic Review of Healthy Nutrition Intervention Programs in Kindergarten and Primary Education. Nutrients. 2023 Jan 20;15(3):541. doi: 10.3390/nu15030541.

    PubMed 36771248
  • Rani P, Dhok A. Effects of Pollution on Pregnancy and Infants. Cureus. 2023 Jan 18;15(1):e33906. doi: 10.7759/cureus.33906. eCollection 2023 Jan.

    PubMed 36819435
  • Olutola BG, Phoobane P. A Bibliometric Analysis of Literature on Prenatal Exposure to Air Pollution: 1994-2022. Int J Environ Res Public Health. 2023 Feb 9;20(4):3076. doi: 10.3390/ijerph20043076.

    PubMed 36833768

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Twin, run by University Hospital, Montpellier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Florent FUCHS, MD, PhD (+334 67 33 09 80, f-fuchs@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal extern exposome (time frame: From two years before pregnancy until delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408973, which also lists 19 linked publications.

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 18 Jun 2026.

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