Metformin may stop severe pregnancy sickness before it starts
NCT ID NCT07129473
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study tests whether taking metformin-XR (a diabetes drug) daily before pregnancy can lower the risk and severity of Hyperemesis Gravidarum (HG)—extreme nausea and vomiting in pregnancy—in women aged 18-49 who had HG before and are trying to conceive. Participants either take the drug or join a survey-only group. Researchers will track side effects, HG recurrence, pregnancy outcomes, and newborn health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Mar 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 49 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ages 18-49 * HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment) * Trying to conceive * Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose (up to 8 weeks total). Will use birth control or contraceptive device until maintenance dose. * Under care of a personal OB/GYN or willing to establish care with a personal OB/GYN before study start * Ownership of a personal scale (or willingness to obtain one for study use) * Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy * Treatment Arm: residing in California/Alabama * Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range) * Treatment Arm: normal to mildly decreased creatinine levels (estimated GFR \> 60 mL/min/1.73m²) * Survey/Comparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy * Able and willing to provide written informed consent prior to initiation of any study procedures. * Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * English speaking * Regular cycles Exclusion Criteria: * Allergic or adverse reaction to metformin-XR * Thalassemia * Cirrhosis and/or hepatic impairment * Decompensated heart failure * Daily/regular use of medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix) * Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication * Assisted Reproductive Technology * Excess alcohol consumption (\> 7 standard drinks per week on average) * Pregnant * Not trying to conceive * Treatment Arm: Residing outside California/Alabama * Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range) * Treatment Arm: abnormal creatinine levels (estimated GFR \< 60 mL/min/1.73m² excluded from the study, signs of kidney disease) * Treatment Arm: current metformin use * Survey/Comparator Arm: current metformin use or plans to take metformin prior to pregnancy * Any medical/surgical condition that the investigator feels would compromise the participant's participation in the study * Not able and willing to provide written informed consent prior to initiation of any study procedures. * Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * Not english speaking * Irregular cycles * Not willing to refrain from trying to conceive/use birth control or contraceptive device until maintenance dose.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hyperemesis gravidarum are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
The Morning Sickness & HG Clinic
NOT_YET_RECRUITINGBirmingham, Alabama, 35223, United States
Contact Email: •••••@•••••
-
University of Southern California - Keck School of Medicine
RECRUITINGLos Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new score catch severe pregnancy sickness that others miss?
- Could a simple wristband replace drugs for severe morning sickness?
- Could a smartphone app replace hospital visits for Women's emergency aftercare?
- Can hand massage ease severe pregnancy nausea?
- New device could track hydration in pregnancy without needles