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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 is a clinical trial that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 4 participants.
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.
Interventions
- OTHER N/A - No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-09-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02308735
The ClinicalTrials.gov registry entry for NCT02308735 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N/A - No intervention is the first listed.
NCT02308735 reports 0 study locations.
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.
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