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

Sponsor
Hanna Kahila (Other)
Overall Status
Recruiting
CT.gov ID
NCT04571463
Collaborator
Finnish Pediatric Neurology Association (Other), Finnish Foundation for Alcohol Studies (Other), Päijänne Tavastia Central Hospital (Other), Helsinki University Central Hospital (Other), Seinajoki Central Hospital (Other)
600
Enrollment
4
Locations
7.9
Anticipated Duration (Months)
150
Patients Per Site
18.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Etyyliglukuronidin Esiintyminen Virtsassa äitiysneuvola- ja äitiyspoliklinikkakäyntien yhteydessä HUS:n ja PHHYKY:n Alueella
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    May 30, 2021
    Anticipated Study Completion Date :
    May 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. EtG [Day 1]

      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.

    Secondary Outcome Measures

    1. Nicotine [Day 1]

      The positive EtG urine samples and random negative urine samples from the visitors are tested for nicotine using dip sticks.

    2. Cannabis [Day 1]

      The positive EtG urine samples and random negative urine samples from the visitors are tested for cannabis using dip sticks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Pregnant
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HALSO-poliklinikka Lahti Päijät-Häme Finland 715850
    2 Äitiyspoliklinikka/neuvola Lahti Päijät-Häme Finland 715850
    3 HAL-poliklinikka Helsinki Uusimaa Finland 00029
    4 Äitiyspoliklinikka/neuvola Helsinki Uusimaa Finland 00120

    Sponsors and Collaborators

    • Hanna Kahila
    • Finnish Pediatric Neurology Association
    • Finnish Foundation for Alcohol Studies
    • Päijänne Tavastia Central Hospital
    • Helsinki University Central Hospital
    • Seinajoki Central Hospital

    Investigators

    • Principal Investigator: Hanna Kahila, MD, HUCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanna Kahila, Senior Ward Physician, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT04571463
    Other Study ID Numbers:
    • HUS/483/2020
    First Posted:
    Oct 1, 2020
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fetal Alcohol Spectrum Disorders

    Study Results

    No Results Posted as of Oct 5, 2020