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Slovenian study tests baby poop for hidden drug and alcohol use in pregnancy

NCT ID NCT07456579

Knowledge-focused Sponsor: University Medical Centre Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study aims to find out how many pregnant women in Slovenia use alcohol or cannabis by testing their newborns' first stool (meconium) and asking mothers to fill out a survey. Researchers will also compare the gut bacteria of babies exposed to these substances with those who were not. The study involves 600 mothers and their newborns from hospitals across Slovenia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how common alcohol and cannabis use is during pregnancy in Slovenia and whether such use affects the newborn's gut microbiome.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to other countries or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* Random and anonymous meconium samples collected across Slovenian maternity hospitals during the defined study period. Meconium samples will be randomly selected from routine clinical waste (medical waste) generated in maternity hospital, in accordance with the approval of the national ethics committee. * Postpartum women who voluntarily participated by completing the structured questionnaire.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for participation the questionnaire survey: \- Postpartum women who consent to complete the study questionnaire. Exclusion Criteria for participation the questionnaire survey: * Postpartum women who do not provide consent. * Incomplete questionnaire data. Inclusion Criteria for meconium samples: \- Randomly selected meconium samples collected from newborns delivered at the participating maternity hospital during the study period. Exclusion Criteria for meconium samples: * Meconium samples of insufficient quantity or quality for biomarker or microbiome analyses. * Meconium passed in utero (meconium stained amniotic fluid) 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.

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Conditions

The condition(s) this trial relates to.

cannabis dependence Health Risk Behaviors

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol abuse in pregnancy Drug abuse in pregnancy Health behavior, risky Microbiome analysis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University medical centre Ljubljana

    Ljubljana, 1000, Slovenia

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