Prospective Twin Pregnancy Cohort at Montpellier University Hospital

NCT07408973 | Not Yet Recruiting

• 2 other identifiers: RECHMPL23_04762024-A02160-47
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnancy; Twin

Keywords

Exposome; Air Pollutants; Lead; Diet, Food, and Nutrition; Healthy Lifestyle; Obstetric Labor Complications; Children Health

Outcome Measures

Primary Outcomes (3)

• 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.

  From two years before pregnancy until delivery

• 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.

  From two years before pregnancy until delivery

• 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).

  At childbirth

Secondary Outcomes (5)

• Abnormalities in children

  From childbirth to the twins' first birthday

• Obstetric complications

  At childbirth

• Comparison of the Twins

  At childbirth

• Children's extern exposome

  From childbirth to the twins' first birthday

• Children's intern exposome

  From childbirth to the twins' first birthday

Other Outcomes (3)

• Supplement to the mother's exposome

  From inclusion to childbirth

• Supplement to the children's exposome

  From inclusion to the twins' first birthday

• PM and PMT substances

  At inclusion, 6 month of pregnancy

Study Arms (2)

Women pregnant with twins

Other: Biological samples from the mother

Twins newborns

Other: Biological samples from the twins

Interventions

Biological samples from the mother OTHER

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

Women pregnant with twins

Biological samples from the twins OTHER

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

Twins newborns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 born in a twin pregnancy ≥ 25 weeks of gestation

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Related Publications (19)

• 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.

  PMID: 11179140 BACKGROUND

• 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.

  PMID: 21772139 BACKGROUND

• 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.

  PMID: 16103423 BACKGROUND

• 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.

  PMID: 34097167 BACKGROUND

• 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.

  PMID: 22302586 BACKGROUND

• 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.

  PMID: 15188793 BACKGROUND

• 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.

  PMID: 24412490 BACKGROUND

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

  PMID: 10586523 BACKGROUND

• 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.

  PMID: 10521752 BACKGROUND

• 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.

  PMID: 33678251 BACKGROUND

• 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.

  PMID: 36615802 BACKGROUND

• 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.

  PMID: 34503987 BACKGROUND

• 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.

  PMID: 36771248 BACKGROUND

• 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.

  PMID: 36819435 BACKGROUND

• 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.

  PMID: 36833768 BACKGROUND

• Pesce G, Sese L, Calciano L, Travert B, Dessimond B, Maesano CN, Ferrante G, Huel G, Prud'homme J, Guinot M, Soomro MH, Baloch RM, Lhote R, Annesi-Maesano I. Foetal exposure to heavy metals and risk of atopic diseases in early childhood. Pediatr Allergy Immunol. 2021 Feb;32(2):242-250. doi: 10.1111/pai.13397. Epub 2020 Nov 6.

  PMID: 33091176 BACKGROUND

• Fasola S, Montalbano L, Cilluffo G, Cuer B, Malizia V, Ferrante G, Annesi-Maesano I, La Grutta S. A Critical Review of Statistical Methods for Twin Studies Relating Exposure to Early Life Health Conditions. Int J Environ Res Public Health. 2021 Dec 2;18(23):12696. doi: 10.3390/ijerph182312696.

  PMID: 34886424 BACKGROUND

• Monden C, Pison G, Smits J. Twin Peaks: more twinning in humans than ever before. Hum Reprod. 2021 May 17;36(6):1666-1673. doi: 10.1093/humrep/deab029.

  PMID: 33709110 BACKGROUND

• Olsen IE, Groveman SA, Lawson ML, Clark RH, Zemel BS. New intrauterine growth curves based on United States data. Pediatrics. 2010 Feb;125(2):e214-24. doi: 10.1542/peds.2009-0913. Epub 2010 Jan 25.

  PMID: 20100760 BACKGROUND

Related Links

• French perinatal survey 2021

Biospecimen

Retention: SAMPLES WITH DNA

White blood cells derived from maternal blood. Whole blood from the umbilical cord of each twin.

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Florent FUCHS, MD, PhD

  University Hopistal of Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

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

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02