Alcohol and Cannabis Use Among Pregnant Slovenian Women

NCT07456579 | Enrolling By Invitation

• 1 other identifier: 0120-269/2023/3
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbiome Analysis; Drug Abuse in Pregnancy; Alcohol Abuse in Pregnancy; Health Behavior, Risky

Keywords

prevalence; alcohol; cannabis; microbiome; meconium; self report; pregnancy

Outcome Measures

Primary Outcomes (3)

• Prevalence of alcohol and cannabis use among pregnant women in Slovenia determined by biomarkers in meconium.

  The prevalence of alcohol and cannabis use among pregnant women in Slovenia, determined by alcohol and cannabis metabolites in newborns' meconium.

  From all the collected samples in one year period.

• Prevalence of alcohol and cannabis use among pregnant women in Slovenia determined by self reporting

  Prevalence of alcohol and cannabis use among pregnant women in Slovenia determined by self-reported data collected via a structured questionnaire

  1 year

• Micorbiome analysis

  The meconium microbiome of newborns whose mothers consumed alcohol and/or cannabis during pregnancy differs from the microbiome of newborns whose mothers did not consume alcohol and/or cannabis during pregnancy.

  Sample collection approximately one year period. Biomarcers analysis 1 year. Microbioma analysis 6 months.

Secondary Outcomes (1)

• Health behavior and life style during pregnancy

  One year period.

Study Arms (3)

Meconium samples that will not be paired with maternal questionnaires

Random meconium samples form 13 Slovenian maternity hospitals will be collected. Parallel to that, we will colect maternal questionnaires. Meconium samples and questionnaires will be randomly colected, they will not be paired. No personal data will be collected.

Meconium samples that will be paired with maternal questionnaires

In this group we will pair maternal questionnaire with meconium sample. First we will ask permission from mother to be voluntarily included in the study, she will sign written consent. Then she will fullfil the questionnaire and we will collect meconium sample of her newborn. We will put code on her questionnaire and on the meconium sample to maintain anonymity, without collection any personal data. The aim of the paired group is to evaluate the thruthfulness of self-reporting.

Postpartum women

Postpartum women will be invited to complete structured questionnaire addressing lifestyle factors during pregnancy, including self-reported alcohol, tobacco, and drug use.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Random and anonymous meconium samples collected across Slovenian maternity hospitals during the defined study period. * Postpartum women who voluntarily participated by completing the structured questionnaire.

You may qualify if:

• meconium samples of preterm and term neonates

You may not qualify if:

• if the neonate passes meconium intrauterine (meconium stained amniotic fluid) or during the labour
• \- any postpatrum women
• Probability sampling will be applied to the selection of meconium samples, which will be collected randomly. In contrast, postpartum women will be recruited upon invitation, representing a non-probability (convenience) sample.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• National Institute of Public Health, Slovenia: collaborator

Study Sites (1)

University medical centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (19)

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  PMID: 32060189 BACKGROUND

• Wang Y, Xie T, Wu Y, Liu Y, Zou Z, Bai J. Impacts of Maternal Diet and Alcohol Consumption during Pregnancy on Maternal and Infant Gut Microbiota. Biomolecules. 2021 Mar 1;11(3):369. doi: 10.3390/biom11030369.

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• Mattson SN, Bernes GA, Doyle LR. Fetal Alcohol Spectrum Disorders: A Review of the Neurobehavioral Deficits Associated With Prenatal Alcohol Exposure. Alcohol Clin Exp Res. 2019 Jun;43(6):1046-1062. doi: 10.1111/acer.14040. Epub 2019 May 2.

  PMID: 30964197 BACKGROUND

• Hoyme HE, Kalberg WO, Elliott AJ, Blankenship J, Buckley D, Marais AS, Manning MA, Robinson LK, Adam MP, Abdul-Rahman O, Jewett T, Coles CD, Chambers C, Jones KL, Adnams CM, Shah PE, Riley EP, Charness ME, Warren KR, May PA. Updated Clinical Guidelines for Diagnosing Fetal Alcohol Spectrum Disorders. Pediatrics. 2016 Aug;138(2):e20154256. doi: 10.1542/peds.2015-4256. Epub 2016 Jul 27.

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Biospecimen

Retention: SAMPLES WITH DNA

meconium

MeSH Terms

Conditions

Health Risk Behaviors; Marijuana Abuse

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, dr. of science, Jana Lozar Krivec, consultant in pediatrics and neonatology

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: May 5, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 3 years after the publication of results
• Access Criteria: Individual participant data (IPD) and supporting information will be made available to researchers who provide a methodologically sound proposal and justify their request. Access will be granted upon reasonable request, subject to approval by the study investigators and in accordance with applicable ethical and data protection regulations. Requests should be directed to the corresponding author.

Locations

SL (1)