Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Completed

• Conditions: Birth Weight; Large for Gestational Age at Delivery (Macrosomia); Preeclampsia; Hypertension in Pregnancy; Congenital Malformation; Small for Gestational Age at Delivery; Diabetes, Gestational

• Registration Number: NCT05810545
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Status Verified: 2023-04
• Study First Posted: 2023-04-12
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256659

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth outcome - birthweight	at birth	grams as measured at birth
Birth outcome - Small for gestational age (SGA)	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)	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	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	during gestation	ICD10-codes: O13-O14. Diagnosis at maternal or primary care
Maternal health - Gestational diabetes mellus	during gestation	ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care