Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

NCT05810545 | Completed

• 2 other identifiers: EXP-21-CV83012022-00980
• Study Type: observational
• Target: 256,659
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Birth outcome - birthweight

  grams as measured at birth

  at birth

• Birth outcome - Small for gestational age (SGA)

  \<-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)

  \>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

  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

  ICD10-codes: O13-O14. Diagnosis at maternal or primary care

  during gestation

• Maternal health - Gestational diabetes mellus

  ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care

  during gestation

Interventions

Per- and polyfluoroalkyl substances (PFAS) OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Birth Weight; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Congenital Abnormalities

Interventions

Fluorocarbons

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: January 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share