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Metformin may stop severe pregnancy sickness before it starts

NCT ID NCT07129473

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

Morning Sickness Nausea Vomiting hyperemesis gravidarum prevention target

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • The Morning Sickness & HG Clinic

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35223, United States

    Contact Email: •••••@•••••

  • University of Southern California - Keck School of Medicine

    RECRUITING

    Los Angeles, California, 90033, United States

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