Trial Outcomes & Findings for Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial (NCT NCT02308735)
NCT ID: NCT02308735
Last Updated: 2021-02-21
Results Overview
A measure of ethanol metabolites in the meconium of an infant.
Recruitment status
TERMINATED
Target enrollment
4 participants
Primary outcome timeframe
Three months
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
Control
Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).
N/A - No intervention
|
A1 IDM
Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).
N/A - No intervention
|
A2 IDM
Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).
N/A - No intervention
|
PGDM - IDM
Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).
N/A - No intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Control
Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).
N/A - No intervention
|
A1 IDM
Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).
N/A - No intervention
|
A2 IDM
Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).
N/A - No intervention
|
PGDM - IDM
Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).
N/A - No intervention
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
2
|
Baseline Characteristics
Samples were never sent for analysis due to lack of funding for study.
Baseline characteristics by cohort
| Measure |
Control
n=2 Participants
Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).
N/A - No intervention
|
A1 IDM
Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).
N/A - No intervention
|
A2 IDM
Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).
N/A - No intervention
|
PGDM - IDM
n=2 Participants
Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).
N/A - No intervention
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 1 • n=99 Participants • Samples were never sent for analysis due to lack of funding for study.
|
—
|
—
|
28.5 years
STANDARD_DEVIATION 4.5 • n=7 Participants • Samples were never sent for analysis due to lack of funding for study.
|
29.8 years
STANDARD_DEVIATION 3.5 • n=31 Participants • Samples were never sent for analysis due to lack of funding for study.
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
—
|
2 participants
n=7 Participants
|
0 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Three monthsPopulation: This study enrolled four mother/infant dyads but never had results due to low enrollment number
A measure of ethanol metabolites in the meconium of an infant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Three monthsA measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A1 IDM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A2 IDM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PGDM - IDM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Douglas Dannaway
University of Oklahoma Health Sciences Center
Phone: 405-271-5215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place