Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/9/2019 |
| Start Date: | April 2019 |
| End Date: | December 2020 |
| Contact: | Maisa N Feghali, MD |
| Email: | feghalim@upmc.edu |
| Phone: | 4126471000 |
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.
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.
Inclusion Criteria:
- Pregnant women 18-50 years
- 12 0/7 and 19 6/7 weeks of gestation
- Diagnosed with type 1 DM prior to pregnancy.
Exclusion Criteria:
- Known allergy or adverse reaction to metformin
- Multiple gestation
- Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or
suspected fetal aneuploidy
- Medical comorbidities that increase risk for metformin use: renal insufficiency
(creatinine > 1.1 mg/dL), proteinuria (P:C >0.3 or 24-hour urine protein > 300 mg),
active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal
liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative
colitis), major hematologic disorder (including alloimmune and isoimmune
thrombocytopenia).
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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