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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04571463
Other study ID # HUS/483/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date July 30, 2021

Study information

Verified date November 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 505
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Pregnant Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Äitiyspoliklinikka/neuvola Helsinki Uusimaa
Finland HAL-poliklinikka Helsinki Uusimaa
Finland Äitiyspoliklinikka/neuvola Lahti Päijät-Häme
Finland HALSO-poliklinikka Lahti Päijät-Häme

Sponsors (6)

Lead Sponsor Collaborator
Hanna Kahila Finnish Foundation for Alcohol Studies, Finnish Pediatric Neurology Association, Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, Seinajoki Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Nicotine The positive EtG urine samples and random negative urine samples from the visitors are tested for nicotine using dip sticks. Day 1
Secondary Cannabis The positive EtG urine samples and random negative urine samples from the visitors are tested for cannabis using dip sticks. Day 1
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