Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 45 |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
| End Date: | October 2016 |
| Contact: | Douglas C Dannaway, MD |
| Email: | douglas-dannaway@ouhsc.edu |
| Phone: | 4052715215 |
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.
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.
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.
We found this trial at
1
site
Oklahoma City, Oklahoma 73104
Principal Investigator: Douglas C Dannaway, MD
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