Congenital Malformations and Intrauterine Pollutants Exposure (Alcohol, Solvents and Pesticides) in Brittany. Population Based Case-control Study Short Title : Malformations and Environment Acronym : PENEW for "Pregnancy Environment and Newborn Malformations"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,657
- 试验地点
- 21
- 主要终点
- impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
研究概览
简要总结
Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim of malformation registries is to carry out epidemiologic surveillance of congenital anomalies. The objectives are mainly to provide essential epidemiologic information on congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an information and resource centre regarding clusters, to provide data for research related to the causes and prevention of congenital anomalies.
A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida, diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence regarding congenital heart diseases and hypospadia. In this study the investigators could not determine whether this was due to a real higher frequency or to a particular exhaustiveness in the recording methodology.
There are hypothesis about the role of intrauterine exposure to pesticides, known as endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive agricultural area, and it is thus worth studying the impact of pesticides exposure on congenital anomalies.
There are also hypothesis on the impact of occupational exposure to solvents on congenital anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8% pregnant women in France) on oro-facial clefts and congenital heart diseases.
The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
Secondary objectives are to study other risk factors such as medicine intake, pregnancy illness...
详细描述
Population based case-control study:
2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case.
INVESTIGATION METHODOLOGY :
All maternity in Brittany were proposed to participate. In each maternity, the referent practitioner informs the parents and includes the cases.
For each case and control, meconium samples and a mother's lock are collected by nurses or midwives, medical data are collected from medical reports by the registry investigator, and a self-questionnaire is filled by the mother.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy for medical reasons (IMG) from 20 weeks of amenorrhea (SA) included.
- •born from mothers living in Brittany at delivery
- •with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
- •or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one) Suspicion of chromosomal abnormality or genetic syndrome on purely clinical criteria but not yet authenticated by genetic analyzes. If the chromosomal or genetic abnormalities are secondarily authenticated, these cases will be excluded a posteriori.
- •Non inclusion criteria :
- •Spontaneous abortion before 22 weeks gestational age.
- •IMG before the 20 week term amenorrhea
- •Chromosomal abnormalities or syndromes genetic authenticated by karyotype or analysis in molecular biology, in antenatal
- •Mother with legal protection (guardianship)
排除标准
- •Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution
结局指标
主要结局
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
时间窗: up to 48 hours
impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.
次要结局
- other risk factors such as medicine intake, pregnancy illness…(up to 48 hours)