CClinicalTrials.gg
Status unknownNCT04918043RASMEK21Updated Jun 8, 2021

Alcohol Use During Pregnancy in Finland According to Meconium Samples

An observational study in Fetal Alcohol Spectrum Disorders, sponsored by Hanna Kahila. Status unknown. Open to participants aged Up to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Hanna Kahila · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,000
Ages
Up to 3 Days
Sex
All
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Study summary

Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.

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Conditions studied

  • Fetal Alcohol Spectrum Disorders
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In context

Fetal Alcohol Spectrum Disorders

63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.

Browse Fetal Alcohol Spectrum Disorders studies →

Lead sponsor

Hanna Kahila is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 3 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consists of the newborn babies that are born at the Helsinki University Central hospital maternity ward.

Inclusion criteria

  • newborn baby

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HUCS, NKL

    Newborns and their mothers at the Helsinki University Central Hospital maternity ward.

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What researchers measure

Primary outcomes

  1. EtG

    The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry.

    Time frame: Once

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — All anonymous IPD will be shared with the modelling source code.

Supporting information: Icf, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04918043
Lead sponsor
Hanna Kahila
Collaborators
Helsinki University Central Hospital, Lastentautien tutkimussäätiö
Responsible party
Hanna Kahila (MD, Helsinki University Central Hospital) — Sponsor-investigator
First posted
Jun 8, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Aug 30, 2021 (estimated)
Last update
Jun 8, 2021

Study contacts

Mikko Koivu-Jolma
Contact
mikko.koivu-jolma@helsinki.fi
+358414873836
Hanna Kahila, MD
principal investigator · HUCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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