Fetal Alcohol SyndromeNCT02600624
Prenatal Alcohol Biomarker Study in Uruguay
An observational study of Fetal Alcohol Syndrome, run by Northwestern University at 2 sites in 2 countries.
Trial summary
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Alcohol Syndrome
- How many people
- 1,412 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Aug 2016to Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are admitted public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell) for obstetrical care will be recruited to participate in the study.
Who may be able to join
- Pregnant women 18 years and older
- Admitted in active labor as well as their newborn child
- Well enough to participate in the research interview
- Able to provide fingernail, hair, and blood spot samples
- All subjects must have given signed, informed consent prior to registration
Who cannot join
- Not meeting the appropriate inclusion criteria or providing consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Uruguay1 site
Clínica Ginecología/Obstétrica del Hospital General de las Fuerzas Armadas de Uruguay
Montevideo
About this study
Official title: Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.
Read the detailed description
The goal of the proposed research study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn children, in a country (Uruguay) where significant alcohol use is common during pregnancy. Maternal alcohol biomarker assays will include ethyl glucuronide (EtG) in hair and nails and PEth in blood obtained at the time of delivery. Newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn PEth levels. Maternal biomarker levels will be compared to patient self-reported alcohol use. This proposed design is a cross-sectional study that will include 1,800 women 18 years and older and their newborns. Women who are admitted to one of two selected public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell and Servicio Medico Integral) for obstetrical care will be recruited to participate in the study. Power estimates suggest that 1,800 maternal/infant pairs will give us sufficient power (>90%) to estimate the predictive validity of this biomarker as a routine newborn screening test.
- Conditions
- Fetal Alcohol Syndrome
- 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 |
|---|---|---|
| Participants | Women who are in active labor and their newborn infants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
Conduct a formative assessment of the prevalence and patterns of maternal alcohol consumption during pregnancy and the relationship of these reported patterns to maternal biomarker levels (EtG in hair and nails and PEth in blood) in a large sample (n=1800) of pregnant women in Montevideo, Uruguay.
Measured: The maternal questionnaire will occur during the 48 hrs following childbirth
Secondary outcomes (1)
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
Biomarkers will be collected to determine the correlations between maternal self-report of alcohol consumption, maternal alcohol biomarker levels and newborn PEth concentration levels at birth. It will also help identify the sensitivity and specificity of PEth and the predictive value of newborn PEth levels; and the half-life and window of detection of PEth in newborns by examining the kinetics of PEth elimination.
Measured: PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start18 Aug 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fleming, Northwestern University
- Investigators
- Michael Fleming, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600624
- Sponsor's protocol ID
- STU00200504
- Status last verified
- Apr 2020
- First submitted
- 3 Nov 2015
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
- ClinicalTrials.gov ID
- NCT02600624
- Acronym / sponsor ID
- STU00200504
- Conditions
- Fetal Alcohol Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,412 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 9 Nov 2015 (estimated)
- 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.
The purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn.
Detailed description
The goal of the proposed research study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (PEth) levels in their newborn children, in a country (Uruguay) where significant alcohol use is common during pregnancy. Maternal alcohol biomarker assays will include ethyl glucuronide (EtG) in hair and nails and PEth in blood obtained at the time of delivery. Newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn PEth levels. Maternal biomarker levels will be compared to patient self-reported alcohol use. This proposed design is a cross-sectional study that will include 1,800 women 18 years and older and their newborns. Women who are admitted to one of two selected public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell and Servicio Medico Integral) for obstetrical care will be recruited to participate in the study. Power estimates suggest that 1,800 maternal/infant pairs will give us sufficient power (>90%) to estimate the predictive validity of this biomarker as a routine newborn screening test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Women who are in active labor and their newborn infants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are admitted public health care hospitals in Montevideo, Uruguay (Hospital Pereira Rossell) for obstetrical care will be recruited to participate in the study.
Key inclusion criteria (5 listed)
- Pregnant women 18 years and older
- Admitted in active labor as well as their newborn child
- Well enough to participate in the research interview
- Able to provide fingernail, hair, and blood spot samples
- All subjects must have given signed, informed consent prior to registration
Key exclusion criteria (1 listed)
- Not meeting the appropriate inclusion criteria or providing consent
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
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
Time frame: The maternal questionnaire will occur during the 48 hrs following childbirth
Conduct a formative assessment of the prevalence and patterns of maternal alcohol consumption during pregnancy and the relationship of these reported patterns to maternal biomarker levels (EtG in hair and nails and PEth in blood) in a large sample (n=1800) of pregnant women in Montevideo, Uruguay.
1 secondary outcome
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay
Time frame: PEth and EtG Biomarkers from the mothers and newborns will be collected during the 48 hrs after childbirth.
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 3 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Michael Fleming, MD, MPH principal investigator
Northwestern University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Alcohol Syndrome, run by Northwestern University at 2 sites in 2 countries.
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 5 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uruguay. 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?
Newborn Phosphatidylethanol Screening to Detect Fetal Alcohol Exposure in Uruguay (time frame: The maternal questionnaire will occur during the 48 hrs following childbirth). 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 3 Apr 2020.