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Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05810545
Enrollment
256659
Registered
2023-04-12
Start date
2012-01-01
Completion date
2018-12-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERPer- and polyfluoroalkyl substances (PFAS)

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Birth outcome - birthweightat birthgrams 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 malformationsat birthICD10- 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/preeclampsiaduring gestationICD10-codes: O13-O14. Diagnosis at maternal or primary care
Maternal health - Gestational diabetes mellusduring gestationICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026