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临床试验/NCT05810545
NCT05810545已完成不适用

Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Karolinska Institutet0 个研究点目标入组 256,659 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
256,659
主要终点
Birth outcome - birthweight

研究概览

简要总结

The aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018

排除标准

  • Lack of data of PFAS levels in municipal drinking water (entire localities excluded)
  • Mothers not living in the study area consistently between first trimester and four years prior to birth

结局指标

主要结局

Birth outcome - birthweight

时间窗: at birth

grams as measured at birth

Birth outcome - Small for gestational age (SGA)

时间窗: at birth

\<-2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)

Birth outcome - Large for gestational age (LGA)

时间窗: at birth

\>2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)

Birth outcome - major congenital malformations

时间窗: at birth

ICD10- codes: Q00-Q99 within the first 28 days postpartum, categorized as major congenital malformations according to European Surveillance of Congenital Anomalies (EUROCAT 2014)

Maternal health - Gestational hypertension/preeclampsia

时间窗: during gestation

ICD10-codes: O13-O14. Diagnosis at maternal or primary care

Maternal health - Gestational diabetes mellus

时间窗: during gestation

ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agneta Åkesson

Professor

Karolinska Institutet

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