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ENROLLING BY INVITATION
NCT07456579

Alcohol and Cannabis Use Among Pregnant Slovenian Women

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

Summary

The aim of the study is to determine the prevalence of alcohol and drug use among Slovenian pregnant women. Alcohol and drug use during pregnancy has significant effects on the foetus and has short- and long-term health consequences. One of the most serious consequences is foetal alcohol syndrome, which is characterised by congenital anomalies, cognitive impairment and growth deficits. The prevalence of alcohol and drug use during pregnancy will be investigated in collaboration with the National Institute of Public Health, the Institute of Forensic Medicine of the Faculty of Medicine, University of Ljubljana, Institute Jozef Stefan and the Clinical Department of Neonatology of the Paediatric Clinic, University Clinical Centre Ljubljana, using two different methods. A cross-sectional study will be conducted on a nationally representative sample of meconium samples. Meconium samples will be collected from maternity hospitals in Slovenia. Biomarkers for alcohol and illicit drugs will be determined in the meconium samples.Meconium samples will be collected anonymously. National survey on the lifestyle will be conducted in Slovenian maternity hospitals, including questions on alcohol and drug use during pregnancy. The survey will be anonymous and not related to meconium sampling; participation in the survey will be voluntary. Data linkage between questionnaire responses and meconium analysis will be performed only within the additional subgroup of participants who provided informed consent. Meconium samples that will test positive for either alcohol of canabis will be analysed for microbiome. For every poisitve meconium sample, two negative samples will be analysed.

Official title: Assessment of Alcohol and Cannabis Use Among Pregnant Women in Slovenia and Meconium Microbiome Analysis of Positive Samples

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-05-05

Completion Date

2026-04

Last Updated

2026-03-06

Healthy Volunteers

Yes

Locations (1)

University medical centre Ljubljana

Ljubljana, Slovenia