Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Public ClinicalTrials.gov record NCT02308735. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States. Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is also increasing, mainly due to an increase in the diagnosis of non-insulin dependent diabetes mellitus. A recent study demonstrated that 1.3% of pregnancies are now complicated by PGDM and that PGDM now comprises 21% of the diabetes that complicate gestations, which represents a two fold increase since 1999. One notable side effect of diabetes is an elevation of endogenous ethanol production, which in turn may result in a rise in fetal production of fatty acid ethyl ester (FAEE). FAEE found in meconium have been utilized as a marker of prenatal ethanol exposure. Therefore, FAEE elevation could call into question maternal claims of abstinence from alcohol during pregnancy. This study seeks to determine if meconium FAEE levels in the newborns of abstinent women with various classifications of diabetes mellitus are increased when compared to non-diabetic, abstaining controls.
Study identification
- NCT ID
- NCT02308735
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- Aug 31, 2017
- Completion
- Aug 31, 2017
- Last update posted
- Feb 20, 2021
2014 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02308735, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2021 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02308735 live on ClinicalTrials.gov.