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

November 25, 2022 updated by: Hanna Kahila

Etyyliglukuronidin Esiintyminen Virtsassa äitiysneuvola- ja äitiyspoliklinikkakäyntien yhteydessä HUS:n ja PHHYKY:n Alueella

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Päijät-Häme
      • Lahti, Päijät-Häme, Finland, 715850
        • HALSO-poliklinikka
      • Lahti, Päijät-Häme, Finland, 715850
        • Äitiyspoliklinikka/neuvola
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • HAL-poliklinikka
      • Helsinki, Uusimaa, Finland, 00120
        • Äitiyspoliklinikka/neuvola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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).

Description

Inclusion Criteria:

  • Pregnant

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EtG
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine
Time Frame: Day 1
The positive EtG urine samples and random negative urine samples from the visitors are tested for nicotine using dip sticks.
Day 1
Cannabis
Time Frame: Day 1
The positive EtG urine samples and random negative urine samples from the visitors are tested for cannabis using dip sticks.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanna Kahila

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/483/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

6 months after the publication

IPD Sharing Access Criteria

Scientific study, policy making

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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