Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

NCT ID: NCT05810545

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

256659 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Per- 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

OTHER_GOV

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Statistics Sweden

UNKNOWN

Sponsor Role collaborator

National Board of Health and Welfare, Sweden

OTHER_GOV

Sponsor Role collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role collaborator

Swedish Food Agency

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Agneta Åkesson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2022-00980

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EXP-21-CV8301

Identifier Type: -

Identifier Source: org_study_id

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