Status:
TERMINATED
Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Lead Sponsor:
University of Oklahoma
Conditions:
Infants of Diabetic Mothers
Eligibility:
All Genders
Up to 45 years
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, mai...
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. Tho...
Eligibility Criteria
Inclusion
- (understood to include only abstemious women)
- . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies
- . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies
- . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies
- . 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
- . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies)
- . Mothers who had a positive drug screen at any point during their pregnancy (and their babies)
- . Babies whose mothers suffered a placental abruption during their pregnancy.
- . Babies whose mothers had inadequate prenatal care (defined as \<3 prenatal clinic visits prior to admission for delivery)
- . Non-English-speaking mothers
- . Babies who pass meconium in utero.
- . Babies born with multiple congenital anomalies or abdominal wall defects.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02308735
Start Date
March 1 2014
End Date
September 1 2017
Last Update
February 21 2021
Active Locations (1)
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1
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States, 73104