Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT05810545

Collaborator

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

256,659

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Weight Small for Gestational Age at Delivery Large for Gestational Age at Delivery (Macrosomia) Diabetes, Gestational Hypertension in Pregnancy Preeclampsia Congenital Malformation	Other: Per- and polyfluoroalkyl substances (PFAS)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

256659 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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