Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02308735 · ClinicalTrials.gov registry record
Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
A clinical trial, sponsored by University of Oklahoma.
- Terminated
- Registry status
- 4
- Enrollment target
NCT02308735: Clinical Trial study, sponsored by University of Oklahoma.
NCT02308735 is a clinical trial that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02308735 was terminated before completion, sponsored by University of Oklahoma.
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study Summary
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.
Primary Outcome
A measure of ethanol metabolites in the meconium of an infant.
Interventions
- OTHER N/A - No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-09-01 |
Why NCT02308735 stopped before completion
NCT02308735 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which N/A - No intervention is the first listed.
NCT02308735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02308735 about?
NCT02308735 is a clinical study titled "Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial". 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 d...
What is the current status of trial NCT02308735?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2014-03. Estimated completion is 2017-09-01.
What interventions are being tested in trial NCT02308735?
The interventions under investigation include: N/A - No intervention (OTHER).
Who is sponsoring clinical trial NCT02308735?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia