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Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

NCT04523363 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-04-11

No results posted yet for this study

Summary

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Conditions

  • Prediabetes; Complicating Pregnancy

Interventions

DRUG

Metformin

Maximum dosage of 500 mg tablets 2 times a day (with each meal)

Sponsors & Collaborators

  • Gianna Wilkie

    lead OTHER

Principal Investigators

  • Gianna L Wilkie, MD · UMass Memorial Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523363 on ClinicalTrials.gov