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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571463
• Other study ID #: HUS/483/2020
• Status: Completed
• 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
• 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: -

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

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