NCT04571463

Brief Summary

In order to find how many women continue using alcohol during their pregnancies the plan is to anonymously test routine urine samples collected during pregnancies for ethylglucuronide (ETG), a metabolite of ethanol that is detectable in urine up to several days after alcohol consumptions. Altogether 600 samples are taken in the prenatal care units and the prenatal care units dedicated for the alcohol and drug abusing mothers both in the Helsinki and Lahti areas. Test results are used to estimate and compare the prevalence of severe maternal drinking in the different populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

September 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

September 25, 2020

Last Update Submit

November 25, 2022

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

  • EtG

    The routine urine samples from the visitors are tested for ethyl glucuronide using dip sticks with 300ng cut off. Positve finds are confirmed in a laboratory.

    Day 1

Secondary Outcomes (2)

  • Nicotine

    Day 1

  • Cannabis

    Day 1

Study Arms (4)

HUCS A

Mothers visiting the prenatal care units within the Helsinki area.

HUCS HAL

Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Helsinki area.

PHHYKY A

Mothers visiting the prenatal care units within the Lahti area.

PHHYKY HALSO

Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Lahti area.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population for the ethylglucuronide (EtG) testing consists of the visitors in the HYKS, PHHYKY and the cities of Helsinki and Lahti prenatal care units, as well as the HYKS and PHHKYKY prenatal care units dedicated for the alcohol and drug abusing mothers (HAL- / HALSO-poliklinikka).

You may qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HALSO-poliklinikka

Lahti, Paijat-Hame Region, 715850, Finland

Location

Äitiyspoliklinikka/neuvola

Lahti, Paijat-Hame Region, 715850, Finland

Location

HAL-poliklinikka

Helsinki, Uusimaa, 00029, Finland

Location

Äitiyspoliklinikka/neuvola

Helsinki, Uusimaa, 00120, Finland

Location

Related Publications (1)

  • Jolma M, Koivu-Jolma M, Niemela O, Autti-Ramo I, Kahila H. Rapid urine screening for ethyl glucuronide from pregnant women as a tool for detecting prenatal alcohol exposure. BMC Pregnancy Childbirth. 2023 Jun 22;23(1):464. doi: 10.1186/s12884-023-05789-x.

    PMID: 37349673DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

urine

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Ward Physician

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

October 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

All collected anonymized IPD and the modeling source code will be shared.

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

Locations

FI(4)