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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05810545
Other study ID # EXP-21-CV8301
Secondary ID 2022-00980
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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