Clinical trial NCT02308735: Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Official title: Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infants of Diabetic Mothers
Keywords: gestation
diabetes
ethanol
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 4
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Teetotaling pregnant women either without a diagnosis of diabetes (controls) or with a diagnosis of diabetes mellitus (either gestational or pregestational).
2. The liveborn infants resulting from the concurrent pregnancies of the women listed above.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Meconium Fatty Acid Ethyl Ester Concentration
timeFrame: Three months
measure: Phosphatidylethanol Level
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Children's Hospital of Oklahoma
state: Oklahoma
Study officials:
affiliation: Dept of Pediatrics
name: Douglas C Dannaway, MD
role: PRINCIPAL_INVESTIGATOR
References:
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