Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial

Infants of Diabetic Mothers Clinical Trial

— FAEE-IDM  

Official title:

Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02308735
• Other study ID #: 3948
• Status: Terminated
• Start date: March 2014
• Est. completion date: September 1, 2017

Study information

• Verified date: February 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infants of Diabetic Mothers
• Pregnancy in Diabetics

Intervention

Other:
• N/A - No intervention

Locations

Country	Name	City	State
United States	Children's Hospital of Oklahoma	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bakhireva LN, Leeman L, Savich RD, Cano S, Gutierrez H, Savage DD, Rayburn WF. The validity of phosphatidylethanol in dried blood spots of newborns for the identification of prenatal alcohol exposure. Alcohol Clin Exp Res. 2014 Apr;38(4):1078-85. doi: 10.1111/acer.12349. Epub 2014 Feb 11. — View Citation

Bearer CF, Jacobson JL, Jacobson SW, Barr D, Croxford J, Molteno CD, Viljoen DL, Marais AS, Chiodo LM, Cwik AS. Validation of a new biomarker of fetal exposure to alcohol. J Pediatr. 2003 Oct;143(4):463-9. — View Citation

Bell R, Bailey K, Cresswell T, Hawthorne G, Critchley J, Lewis-Barned N; Northern Diabetic Pregnancy Survey Steering Group. Trends in prevalence and outcomes of pregnancy in women with pre-existing type I and type II diabetes. BJOG. 2008 Mar;115(4):445-52. doi: 10.1111/j.1471-0528.2007.01644.x. — View Citation

Bentley-Lewis R, Levkoff S, Stuebe A, Seely EW. Gestational diabetes mellitus: postpartum opportunities for the diagnosis and prevention of type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab. 2008 Oct;4(10):552-8. doi: 10.1038/ncpendmet0965. Epub 2008 Sep 9. Review. — View Citation

Gareri J, Lynn H, Handley M, Rao C, Koren G. Prevalence of fetal ethanol exposure in a regional population-based sample by meconium analysis of fatty acid ethyl esters. Ther Drug Monit. 2008 Apr;30(2):239-45. doi: 10.1097/FTD.0b013e318167cfe5. — View Citation

Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care. 2008 May;31(5):899-904. doi: 10.2337/dc07-2345. Epub 2008 Jan 25. — View Citation

Ostrea EM Jr, Hernandez JD, Bielawski DM, Kan JM, Leonardo GM, Abela MB, Church MW, Hannigan JH, Janisse JJ, Ager JW, Sokol RJ. Fatty acid ethyl esters in meconium: are they biomarkers of fetal alcohol exposure and effect? Alcohol Clin Exp Res. 2006 Jul;30(7):1152-9. — View Citation

Otasevic V, Lazovic V, Spalevic M, Marinkovic O. [Endogenous alcohol in patients with diabetes and in patients with severe liver disease]. Med Glas. 1972 Nov;26(11):391-4. Serbian. — View Citation

Peterson J, Kirchner HL, Xue W, Minnes S, Singer LT, Bearer CF. Fatty acid ethyl esters in meconium are associated with poorer neurodevelopmental outcomes to two years of age. J Pediatr. 2008 Jun;152(6):788-92. doi: 10.1016/j.jpeds.2007.11.009. Epub 2008 Jan 10. — View Citation

Pichini S, Marchei E, Vagnarelli F, Tarani L, Raimondi F, Maffucci R, Sacher B, Bisceglia M, Rapisardi G, Elicio MR, Biban P, Zuccaro P, Pacifici R, Pierantozzi A, Morini L. Assessment of prenatal exposure to ethanol by meconium analysis: results of an Italian multicenter study. Alcohol Clin Exp Res. 2012 Mar;36(3):417-24. doi: 10.1111/j.1530-0277.2011.01647.x. Epub 2011 Dec 14. — View Citation

Simic M, Ajdukovic N, Veselinovic I, Mitrovic M, Djurendic-Brenesel M. Endogenous ethanol production in patients with diabetes mellitus as a medicolegal problem. Forensic Sci Int. 2012 Mar 10;216(1-3):97-100. doi: 10.1016/j.forsciint.2011.09.003. Epub 2011 Sep 25. — View Citation

Zelner I, Shor S, Lynn H, Roukema H, Lum L, Eisinga K, Koren G. Clinical use of meconium fatty acid ethyl esters for identifying children at risk for alcohol-related disabilities: the first reported case. J Popul Ther Clin Pharmacol. 2012;19(1):e26-31. Epub 2012 Jan 10. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meconium Fatty Acid Ethyl Ester Concentration	A measure of ethanol metabolites in the meconium of an infant.	Three months
Primary	Phosphatidylethanol Level	A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.	Three months