Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial (NCT02308735) | Clinical Trial Compass
TerminatedNot Applicable
Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Stopped: Technology has advanced beyond the applicability of the study
United States4 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies
✓. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies
✓. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies
✓. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies.
Exclusion criteria
✕. . 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)