Fetal Alcohol Spectrum DisordersNCT04571463
Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
An observational study of Fetal Alcohol Spectrum Disorders, run by Hanna Kahila at 4 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- How many people
- 505 participants
- Where
- 4 sitesFinland
- Study dates
- 1 Oct 2020to 30 Jul 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- Pregnant
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
HAL-poliklinikka
Helsinki, Uusimaa, 00029
Äitiyspoliklinikka/neuvola
Helsinki, Uusimaa, 00120
HALSO-poliklinikka
Lahti, Paijat-Hame Region, 715850
Äitiyspoliklinikka/neuvola
Lahti, Paijat-Hame Region, 715850
About this study
Official title: Etyyliglukuronidin Esiintyminen Virtsassa äitiysneuvola- ja äitiyspoliklinikkakäyntien yhteydessä HUS:n ja PHHYKY:n Alueella
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.
- 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 A | Mothers visiting the prenatal care units within the Helsinki area. | |
| HUCS HAL | Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Helsinki area. | |
| PHHYKY A | Mothers visiting the prenatal care units within the Lahti area. | |
| PHHYKY HALSO | Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Lahti area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Nicotine
The positive EtG urine samples and random negative urine samples from the visitors are tested for nicotine using dip sticks.
Measured: Day 1
Cannabis
The positive EtG urine samples and random negative urine samples from the visitors are tested for cannabis using dip sticks.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanna Kahila
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Pediatric Neurology Association, Finnish Foundation for Alcohol Studies, Päijänne Tavastia Central Hospital, Helsinki University Central Hospital, Seinajoki Central Hospital
- Responsible party
- Sponsor-investigator, Hanna Kahila, Helsinki University Central Hospital
- Investigators
- Hanna Kahila, MD, Principal investigator, HUCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571463
- Sponsor's protocol ID
- HUS/483/2020
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2020
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected anonymized IPD and the modeling source code will be shared.
Publications
Jolma M, Koivu-Jolma M, Niemela O, Autti-Ramo I, Kahila H. Rapid urine screening for ethyl glucuronide from pregnant women as a tool for detecting prenatal alcohol exposure. BMC Pregnancy Childbirth. 2023 Jun 22;23(1):464. doi: 10.1186/s12884-023-05789-x.
PubMed 37349673
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etyyliglukuronidin Esiintyminen Virtsassa äitiysneuvola- ja äitiyspoliklinikkakäyntien yhteydessä HUS:n ja PHHYKY:n Alueella
- ClinicalTrials.gov ID
- NCT04571463
- Acronym / sponsor ID
- HUS/483/2020
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Hanna KahilaUniversity, hospital or other
- Collaborators
- Finnish Pediatric Neurology Association, Finnish Foundation for Alcohol Studies, Päijänne Tavastia Central Hospital, Helsinki University Central Hospital, Seinajoki Central Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 1 Oct 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HUCS A | – | –Mothers visiting the prenatal care units within the Helsinki area. |
| HUCS HAL | – | –Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Helsinki area. |
| PHHYKY A | – | –Mothers visiting the prenatal care units within the Lahti area. |
| PHHYKY HALSO | – | –Mothers visiting the prenatal care units dedicated for the alcohol and drug abusing mothers within the Lahti area. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- Pregnant
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: Day 1
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.
2 secondary outcomes
Nicotine
Time frame: Day 1
Cannabis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Derived from this study: PubMed 37349673Jolma M, Koivu-Jolma M, Niemela O, Autti-Ramo I, Kahila H. Rapid urine screening for ethyl glucuronide from pregnant women as a tool for detecting prenatal alcohol exposure. BMC Pregnancy Childbirth. 2023 Jun 22;23(1):464. doi: 10.1186/s12884-023-05789-x.
- Individual participant dataSharing planned: Yes. All collected anonymized IPD and the modeling source code will be shared.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Alcohol Spectrum Disorders, run by Hanna Kahila at 4 sites in Finland.
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: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EtG (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571463, which also lists 1 linked publication.
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 28 Nov 2022.