Twin Pregnancy Cohort at Montpellier University Hospital for a Study of the Impact of the Exposome: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 主要终点
- Maternal extern exposome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Women pregnant with twins
干预措施: Biological samples from the mother (Other)
Twins newborns
干预措施: Biological samples from the twins (Other)
结局指标
主要结局
Maternal extern exposome
时间窗: From two years before pregnancy until delivery
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.
Maternal intern exposome
时间窗: From two years before pregnancy until delivery
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.
Abnormal newborn weight
时间窗: At childbirth
Growth retardation: Abnormal birth weight (in kg) for at least one of the two children (\< 3rd percentile according to the Olsen curve).
次要结局
- 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)