| Trial ID: | L5383 |
| Source ID: | NCT02932475
|
| Associated Drug: |
Metformin
|
| Title: |
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
|
| Acronym: |
MOMPOD
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02932475/results
|
| Conditions: |
Diabetes|Pregnancy
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With Composite Adverse Neonatal Outcome, Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Small for gestational age infant (birth weight \< 10th percentile for gestational age) or low birth weight (\< 2500 gm), An average of 48 hours for term infants and 30 days for preterm infants | Secondary: Number of Participants With Maternal Side Effects, Secondary outcome of maternal side effects were defined as: * clinically relevant hypoglycemia defined as capillary blood glucose \< 60 or \< 80 with symptoms * GI side effects defined as nausea, vomiting, diarrhea, Throughout study until delivery at 40 weeks gestation|Mean Infant Fat Mass, Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat)., Within 72 hrs of birth|Maternal Safety Based on Treatment Emergent Adverse Events, Adverse maternal outcomes., An average of 48 hours following delivery|Neonatal Safety Based on Treatment Emergent Adverse Events, Adverse neonatal outcomes, up to 28 days of life
|
| Sponsor/Collaborators: |
Sponsor: University of North Carolina, Chapel Hill | Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
831
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-05-25
|
| Completion Date: |
2022-06-15
|
| Results First Posted: |
2023-05-24
|
| Last Update Posted: |
2023-06-26
|
| Locations: |
University of Alabama, Birmingham, Alabama, 35294, United States|University of California - San Diego, San Diego, California, 92093, United States|University of Mississippi, Jackson, Mississippi, 38677, United States|Columbia University, New York, New York, 10027, United States|University of North Carolina, Chapel Hill, North Carolina, 27599, United States|Ohio State University, Columbus, Ohio, 43210, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|University of Texas Medical Branch, Galveston, Texas, 77555, United States|University of Texas - Houston, Houston, Texas, 77030, United States|University of Utah, Salt Lake City, Utah, 84112, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02932475
|
