Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Preeclampsia Clinical Trial

Official title:

Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810545
• Other study ID #: EXP-21-CV8301
• Secondary ID: 2022-00980
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256659
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Congenital Abnormalities
• Congenital Malformation
• Diabetes, Gestational
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia
• Small for Gestational Age at Delivery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

Outcome

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