Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

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.

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Key information

Conditions

Birth Weight Body Weight Cardiovascular Diseases Congenital Abnormalities Congenital Malformation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hypertension in Pregnancy Hypertension, Pregnancy-Induced Large for Gestational Age at Delivery (Macrosomia) Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pre-Eclampsia Preeclampsia Pregnancy Complications Signs and Symptoms Small for Gestational Age at Delivery Urogenital Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Per- and polyfluoroalkyl substances (PFAS)

Other

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 based cohort.

Primary outcomes

Birth outcome - birthweight

Time frame: at birth

grams as measured at birth
Birth outcome - Small for gestational age (SGA)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: during gestation

ICD10-codes: O13-O14. Diagnosis at maternal or primary care
Maternal health - Gestational diabetes mellus

Time frame: during gestation

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

National Board of Health and Welfare, Sweden
Statistics Sweden
Swedish Food Agency
Swedish University of Agricultural Sciences
The Swedish Research Council
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Registry information

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Apr 12, 2023
Registry last updated: Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed