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

• Sponsor: Maisa N. Feghali, MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03570632
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40.8
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Pregnancy in Diabetes	Drug: Metformin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
• Actual Study Start Date: Jul 8, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care
Experimental: Metformin	Drug: Metformin; Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy

Outcome Measures

Primary Outcome Measures

1. Rate of hypertensive disorders of pregnancy [Delivery/End of pregnancy]

Secondary Outcome Measures

1. Home glucose levels throughout pregnancy [Weekly, throughout pregnancy from enrollment to delivery]

2. Birthweight [Delivery/End of pregnancy]

3. Neonatal morbidity [Delivery/End of pregnancy]

Other Outcome Measures

1. Gestational weight gain [At time of prenatal visits, throughout pregnancy from enrollment to delivery]

2. Umbilical cord c-peptide [Delivery/End of pregnancy]

3. Umbilical cord glucose [Delivery/End of pregnancy]

4. Neonatal body composition [Delivery/End of pregnancy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Maisa N. Feghali, MD

Investigators

• Principal Investigator: Maisa N Feghali, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maisa N. Feghali, MD, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03570632
• Other Study ID Numbers: PRO18050459
• First Posted: Jun 27, 2018
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pre-Eclampsia; Pregnancy in Diabetics; Diabetes Mellitus; Diabetes Mellitus, Type 1; Metformin

Study Results

No Results Posted as of Dec 6, 2021