Clinical Trial

Alcohol and Cannabis Use Among Pregnant Slovenian Women

Enrolling by Invitation
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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 cannabis will be analysed for microbiome. For every positive meconium sample, two negative samples will be analysed.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-13
notable Primary completion pushed: 2026-03-01 -> 2026-06-01 2026-08-13
minor Completion pushed: 2026-04 -> 2026-09 2026-08-13
Trial Details
NCT Number NCT07456579
Lead Sponsor University Medical Centre Ljubljana
Collaborators: National Institute of Public Health, Slovenia
Conditions Microbiome Analysis, Drug Abuse in Pregnancy, Alcohol Abuse in Pregnancy, Health Behavior, Risky
Enrollment 600 participants
Start Date 2024-05-05
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-12