Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Status: | Recruiting |
---|---|
Conditions: | Women's Studies, Diabetes |
Therapuetic Areas: | Endocrinology, Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 6/21/2018 |
Start Date: | May 25, 2017 |
End Date: | June 30, 2021 |
Contact: | Amber Irvins |
Email: | amber_irvins@med.unc.edu |
Phone: | (919) 843-4420 |
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
Purpose: The objective of this proposal is to study the safety and efficacy of metformin
added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.
Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
clinical centers
Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a
singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary
outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth
trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical
visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.
added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.
Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
clinical centers
Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a
singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary
outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth
trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical
visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.
Inclusion Criteria:
- Maternal age 18-45 years
- Singleton pregnancy with no known fetal anomalies
- Gestational age between 10weeks 0 days and 20 weeks 6 days by menstrual dating
confirmed by ultrasound, or ultrasound alone
- Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or
insulin)
- Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days
gestation
- Willing to start insulin therapy and discontinue oral hypoglycemic pills other than
study pills
- Able to swallow pills
Exclusion Criteria:
- Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL
- Clinical history of lactic acidosis
- Known allergy to metformin
- Participation in another study that could affect primary outcome
- Delivery planned at non-MOMPOD study locations
- Unwillingness to use insulin treatment or follow prenatal care doctor's instructions
for insulin and blood glucose monitoring
We found this trial at
10
sites
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: 409-747-4905
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Phone: 212-305-1521
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-4173
University of Utah Research is a major component in the life of the U benefiting...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-615-3817
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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