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Metformin for Prediabetes in Pregnancy

GL
HL
Overseen ByHeidi Leftwich, DO
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Gianna Wilkie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

GL

Gianna L Wilkie, MD

Principal Investigator

UMass Memorial Health

Are You a Good Fit for This Trial?

This trial is for pregnant women receiving care at UMass Memorial Medical Center, who have prediabetes indicated by specific blood sugar tests before the 14th week of gestation. They must be able to consent in writing. It's not for those under 18, with pre-existing diabetes, on metformin already, or if they have liver/renal/heart failure, sensitivity to metformin, a multiple pregnancy or noted fetal defects.

Inclusion Criteria

You received pregnancy and delivery care at University of Massachusetts (UMass) Memorial Medical Center.
Patients able to provide written informed consent
Pregnant women with early signs of high blood sugar levels.

Exclusion Criteria

I am under 18 years old.
I am already taking metformin for a health condition.
You have experienced a miscarriage before being selected for the study.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 14 weeks gestation
1 visit (in-person)

Treatment

Participants are randomized to receive either metformin or standard prenatal care from 14 weeks of pregnancy until delivery

From 14 weeks gestation until delivery
Routine prenatal visits

Follow-up

Participants are monitored for obstetric, maternal, and neonatal outcomes until the 6-week postpartum visit

6 weeks postpartum
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin
Trial Overview The study is testing whether metformin can reduce the risk of having large babies among pregnant women with prediabetes compared to standard treatment without metformin. The goal is to see if this drug can improve outcomes for these pregnancies.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Glucophage for:
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Approved in United States as Glucophage for:
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Approved in Canada as Glucophage for:
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Approved in Japan as Glucophage for:
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Approved in China as Glucophage for:
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Approved in Switzerland as Glucophage for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gianna Wilkie

Lead Sponsor

Trials
2
Recruited
310+
Unbiased ResultsWe believe in providing patients with all the options.
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