Diabetes Mellitus, Type 1, Pregnancy in Diabetes
Conditions
Brief summary
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.
Interventions
DRUGMetformin
Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy
Sponsors
Maisa N. Feghali, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hypertensive disorders of pregnancy | Delivery/End of pregnancy |
Secondary
| Measure | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaisa N Feghali, MD
University of Pittsburgh
Outcome results
None listed