NCT04918043

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

June 8, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 30, 2021

Last Update Submit

May 30, 2021

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

  • EtG

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

    Once

Study Arms (1)

HUCS, NKL

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

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • newborn baby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

meconium

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Hanna Kahila, MD

    HUCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko Koivu-Jolma

CONTACT

+358414873836mikko.koivu-jolma@helsinki.fi

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 8, 2021

Study Start

June 1, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

June 8, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

All anonymous IPD will be shared with the modelling source code.

Shared Documents
ICF, ANALYTIC CODE
Time Frame
6 months after the publication
Access Criteria
Scientific study, policy making