Fetal Alcohol Spectrum DisordersRASMEK21NCT04918043
Alcohol Use During Pregnancy in Finland According to Meconium Samples
An observational study of Fetal Alcohol Spectrum Disorders, run by Hanna Kahila.
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. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of the newborn babies that are born at the Helsinki University Central hospital maternity ward.
Who may be able to join
- newborn baby
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa
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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HUCS, NKL | Newborns and their mothers at the Helsinki University Central Hospital maternity ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EtG
The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanna Kahila
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Lastentautien tutkimussäätiö
- Responsible party
- Sponsor-investigator, Hanna Kahila, Helsinki University Central Hospital
- Investigators
- Hanna Kahila, MD, Principal investigator, HUCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918043
- Sponsor's protocol ID
- HUS/222/2021
- Acronym
- RASMEK21
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymous IPD will be shared with the modelling source code.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa
- ClinicalTrials.gov ID
- NCT04918043
- Acronym / sponsor ID
- RASMEK21 / HUS/222/2021
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hanna KahilaUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Lastentautien tutkimussäätiö
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HUCS, NKL | – | –Newborns and their mothers at the Helsinki University Central Hospital maternity ward. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of the newborn babies that are born at the Helsinki University Central hospital maternity ward.
Key inclusion criteria (1 listed)
- newborn baby
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EtG
Time frame: Once
The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Yes. All anonymous IPD will be shared with the modelling source code.
Related trials for Fetal Alcohol Spectrum Disorders
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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The Synchrony Study: Examining Music Training for Children With FASD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Kahila, MD principal investigator
HUCS
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Alcohol Spectrum Disorders, run by Hanna Kahila.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikko Koivu-Jolma (+358414873836, mikko.koivu-jolma@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EtG (time frame: Once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.