Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1, Pregnancy in Diabetes

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Experimental: Metformin<br> | Drug: Metformin<br>* Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypertensive disorders of pregnancy |  | Delivery/End of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home glucose levels throughout pregnancy |  | Weekly, throughout pregnancy from enrollment to delivery | 
| Birthweight |  | Delivery/End of pregnancy | 
| Neonatal morbidity |  | Delivery/End of pregnancy |