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Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | ||
| Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hypertensive disorders of pregnancy | Delivery/End of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Home glucose levels throughout pregnancy | Weekly, throughout pregnancy from enrollment to delivery | |
| Birthweight | Delivery/End of pregnancy | |
| Neonatal morbidity |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | At time of prenatal visits, throughout pregnancy from enrollment to delivery | |
| Umbilical cord c-peptide | Delivery/End of pregnancy | |
| Umbilical cord glucose |
Inclusion Criteria:
Exclusion Criteria:
Only pregnant women are eligible to participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| Maisa N Feghali, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D011254 | Pregnancy in Diabetics |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Delivery/End of pregnancy |
| Delivery/End of pregnancy |
| Neonatal body composition | Delivery/End of pregnancy |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |