Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

April 13, 2023 updated by: Agneta Åkesson, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

256659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018, where PFAS exposure data is available.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth outcome - birthweight
Time Frame: at birth
grams as measured at birth
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)
at birth
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)
at birth
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)
at birth
Maternal health - Gestational hypertension/preeclampsia
Time Frame: during gestation
ICD10-codes: O13-O14. Diagnosis at maternal or primary care
during gestation
Maternal health - Gestational diabetes mellus
Time Frame: during gestation
ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care
during gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-21-CV8301
  • 2022-00980 (Other Grant/Funding Number: Swedish Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is available from registers at Statistics Sweden and National Board of Health and Welfare in Sweden.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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