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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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