Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area

NCT ID: NCT04571463

Last Updated: 2022-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Alcohol Spectrum Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HUCS A

Mothers visiting the prenatal care units within the Helsinki area.

No interventions assigned to this group

HUCS HAL

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

No interventions assigned to this group

PHHYKY A

Mothers visiting the prenatal care units within the Lahti area.

No interventions assigned to this group

PHHYKY HALSO

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pregnant

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Finnish Pediatric Neurology Association

UNKNOWN

Sponsor Role collaborator

Finnish Foundation for Alcohol Studies

OTHER

Sponsor Role collaborator

Päijänne Tavastia Central Hospital

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Seinajoki Central Hospital

OTHER

Sponsor Role collaborator

Hanna Kahila

OTHER

Sponsor Role lead

Responsible Party

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Hanna Kahila

Senior Ward Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hanna Kahila, MD

Role: PRINCIPAL_INVESTIGATOR

HUCS

Locations

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HALSO-poliklinikka

Lahti, Paijat-Hame Region, Finland

Site Status

Äitiyspoliklinikka/neuvola

Lahti, Paijat-Hame Region, Finland

Site Status

HAL-poliklinikka

Helsinki, Uusimaa, Finland

Site Status

Äitiyspoliklinikka/neuvola

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 37349673 (View on PubMed)

Other Identifiers

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HUS/483/2020

Identifier Type: -

Identifier Source: org_study_id

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