Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Stopped early
Conditions studied: Infants of Diabetic Mothers
In brief
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.
Key facts
- Study ID
- NCT02308735
- Run by
- University of Oklahoma
- People needed
- 4
- Starts
- 2014-03-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2021-02-21
Who can join
Age: any, up to 45. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies)
- . Mothers who had a positive drug screen at any point during their pregnancy (and their babies)
- . Babies whose mothers suffered a placental abruption during their pregnancy.
- . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic visits prior to admission for delivery)
- . Non-English-speaking mothers
- . Babies who pass meconium in utero.
- . Babies born with multiple congenital anomalies or abdominal wall defects.
Where it is running
- Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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