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NCT04918043 Clinical Trial

Alcohol Use During Pregnancy in Finland According to Meconium Samples

Fetal Alcohol Spectrum Disorders Clinical Trial

— RASMEK21  

Official title:
Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04918043
Other study ID # HUS/222/2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date August 30, 2021

Study information
Verified date May 2021
Source Helsinki University Central Hospital
Contact Mikko Koivu-Jolma
Phone +358414873836
Email mikko.koivu-jolma@helsinki.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Days
Eligibility Inclusion Criteria: - newborn baby Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Hanna Kahila Helsinki University Central Hospital, Lastentautien tutkimussäätiö

Outcome
Type Measure Description Time frame Safety issue
Primary EtG The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry. Once
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