Recruiting soon

Metformin for Hyperemesis Gravidarum Prevention in Pregnancy

What is being tested

Metformin Extended Release Oral Tablet

Drug

Who is being recruted

Urogenital Diseases+7

+ Female Urogenital Diseases and Pregnancy Complications

+ Hyperemesis Gravidarum

From 18 to 49 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorUniversity of Southern California

Study ContactMarlena Fejzo, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out if a medication called metformin extended-release (metformin-XR) can help prevent or lessen the severity of Hyperemesis Gravidarum (HG), which causes severe nausea and vomiting during pregnancy. The study targets women aged 18-49 who have experienced HG in a previous pregnancy and are trying to become pregnant again. The importance of this study lies in potentially offering a preventive treatment for those at high risk of experiencing HG again, which could lead to better health outcomes for both mothers and their future babies. Participants in this study are divided into two groups. One group will take the metformin-XR pill daily before becoming pregnant, while the other group will not take the medication and will only complete surveys. Participants in the treatment group will also attend brief study visits and have blood tests to monitor certain health markers and ensure safety. The study aims to measure if metformin-XR is well-tolerated and if it effectively reduces the recurrence and severity of HG, contributing to improved health outcomes for mothers and their babies.

Official TitleHyperemesis Gravidarum Risk Reduction With Metformin

NCT07129473

Principal SponsorUniversity of Southern California

Study ContactMarlena Fejzo, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

224 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHyperemesis GravidarumNauseaPregnancy ComplicationsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsVomitingMorning Sickness

Criteria

10 inclusion criteria required to participate

Ages 18-49

HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment)

Trying to conceive

Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy

Show More Criteria

14 exclusion criteria prevent from participating

Allergic or adverse reaction to metformin-XR

Chronic diseases/conditions

Daily medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other Selective Serotonin Reuptake Inhibitors (SSRIs))

Assisted Reproductive Technology

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Treatment Arm (N=112): * Individuals with a prior HG pregnancy with intravenous (IV) fluid treatment and current pregnancy intent * Residing in California or Alabama * Daily metformin-XR, escalated from 500 mg to 2000 mg as tolerated * Continue treatment until either 2 weeks post-pregnancy confirmation or up to 12 months

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers