An observational study in Fetal Alcohol Spectrum Disorders, sponsored by Hanna Kahila. Completed at 4 sites in Finland. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-28.
Sponsored by Hanna Kahila · Observational
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.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
Browse Fetal Alcohol Spectrum Disorders studies →Hanna Kahila is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The study population for the ethylglucuronide (EtG) testing consists of the visitors in the HYKS, PHHYKY and the cities of Helsinki and Lahti prenatal care units, as well as the HYKS and PHHKYKY prenatal care units dedicated for the alcohol and drug abusing mothers (HAL- / HALSO-poliklinikka).
Exclusion Criteria:
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Mothers visiting the prenatal care units within the Helsinki area.
Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Helsinki area.
Mothers visiting the prenatal care units within the Lahti area.
Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Lahti area.
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.
Time frame: Day 1
Nicotine
The positive EtG urine samples and random negative urine samples from the visitors are tested for nicotine using dip sticks.
Time frame: Day 1
Cannabis
The positive EtG urine samples and random negative urine samples from the visitors are tested for cannabis using dip sticks.
Time frame: Day 1
Plan to share: Yes — All collected anonymized IPD and the modeling source code will be shared.
Supporting information: Icf, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Fetal Alcohol Spectrum Disorders→
Hanna Kahila