Clinical trial NCT03570632: Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Official title: Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Pregnancy in Diabetes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of hypertensive disorders of pregnancy
timeFrame: Delivery/End of pregnancy
Secondary outcomes:
measure: Home glucose levels throughout pregnancy
timeFrame: Weekly, throughout pregnancy from enrollment to delivery
measure: Birthweight
timeFrame: Delivery/End of pregnancy
measure: Neonatal morbidity
timeFrame: Delivery/End of pregnancy
Other outcomes:
measure: Gestational weight gain
timeFrame: At time of prenatal visits, throughout pregnancy from enrollment to delivery
measure: Umbilical cord c-peptide
timeFrame: Delivery/End of pregnancy
measure: Umbilical cord glucose
timeFrame: Delivery/End of pregnancy
measure: Neonatal body composition
timeFrame: Delivery/End of pregnancy
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Maisa N Feghali, MD
role: PRINCIPAL_INVESTIGATOR
References: