RASMEK21: Alcohol Use During Pregnancy in Finland According to Meconium Samples
Sponsor
Hanna Kahila (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04918043
Collaborator
Helsinki University Central Hospital (Other), Lastentautien tutkimussäätiö (Other)
1,000
3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa
Anticipated Study Start Date
:
Jun 1, 2021
Anticipated Primary Completion Date
:
Aug 30, 2021
Anticipated Study Completion Date
:
Aug 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HUCS, NKL Newborns and their mothers at the Helsinki University Central Hospital maternity ward. |
Outcome Measures
Primary Outcome Measures
- EtG [Once]
The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 3 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- newborn baby
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hanna Kahila
- Helsinki University Central Hospital
- Lastentautien tutkimussäätiö
Investigators
- Principal Investigator: Hanna Kahila, MD, HUCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hanna Kahila,
MD,
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04918043
Other Study ID Numbers:
- HUS/222/2021
First Posted:
Jun 8, 2021
Last Update Posted:
Jun 8, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: