Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial (FAEE-IDM)

February 18, 2021 updated by: University of Oklahoma
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Children's Hospital of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).
Other: N/A - No intervention
A1 IDM
Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).
Other: N/A - No intervention
A2 IDM
Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).
Other: N/A - No intervention
PGDM - IDM
Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).
Other: N/A - No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meconium Fatty Acid Ethyl Ester Concentration
Time Frame: Three months
A measure of ethanol metabolites in the meconium of an infant.
Three months
Phosphatidylethanol Level
Time Frame: Three months
A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Douglas C Dannaway, MD, Dept of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3948

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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