Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
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 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.
Researchers will approach four groups of pregnant women at 24-26 weeks when they present for
 routine obstetrical out-patient appointments:

 1. Those with PGDM

 2. Those with White's Class A1 GDM

 3. Those with White's Class A2 GDM

 4. Non-diabetic controls

 The medical records of these women will be examined to determine self-reporting of any
 alcohol or other drug usage while pregnant; women who report any illicit drug use (or ethanol
 use) while pregnant will not be eligible for this study. A routine urine drug screen will
 further confirm this finding. Women who have not reported alcohol use during their pregnancy
 will be questioned regarding medication usage while pregnant, as some medications do contain
 small amounts of ethanol. Women who are judged to have not consumed alcohol during their
 pregnancies (intentionally or incidentally) would then be included in the study.

 Demographic information about the mother would also be collected (age, parity, length of
 pregnancy), as would the mother's most recent glycosylated hemoglobin level; additionally, a
 glycosylated hemoglobin level will be drawn on our presumptive controls (to allow for covert
 gestational diabetes mellitus). This lab draw would be added to the mother's routine lab
 studies and would not require an additional venipuncture.

 A second urine drug screen will be performed on the mother upon her admission to the
 University of Oklahoma Health Sciences Center for the delivery of her baby. If both screens
 are negative and the baby does not meet any of the exclusion criteria, the baby will be
 enrolled in the study.

 The initial meconium from each baby of the recruited mothers will be gathered. Approximately
 1 g of meconium will be collected, frozen, and evaluated for fatty acid ethyl ester analysis
 at the United States Drug Testing Laboratories, Inc. We will also be sending a dried blood
 spot from the baby which will be collected at the time of the baby's scheduled newborn
 screen. This dried blood spot will be evaluated for phosphatidylethanol, an ethanol
 by-product.
Inclusion Criteria: (understood to include only abstemious women)

 1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and
 their babies

 2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class
 A1 diabetes mellitus, and their babies

 3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class
 A2 diabetes mellitus, and their babies

 4. . 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:

 1. . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy
 (and their babies)

 2. . Mothers who had a positive drug screen at any point during their pregnancy (and
 their babies)

 3. . Babies whose mothers suffered a placental abruption during their pregnancy.

 4. . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic
 visits prior to admission for delivery)

 5. . Non-English-speaking mothers

 6. . Babies who pass meconium in utero.

 7. . Babies born with multiple congenital anomalies or abdominal wall defects.