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Hyperemesis Gravidarum Risk Reduction With Metformin

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Phase: Phase 2 to Phase 1/2v3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 2030 to Mar 2031
    • Start date changed from estimate of Jan 2026 to Jul 13, 2026
    • Study sites: 0 to 2
    • Study completion date: Jan 2031 to Mar 2031
    • Eligibility criteria expanded, about 145 words
  2. Start date: Oct 2025 to Jan 2026v2 Show 5 more changesShow less
    • Primary endpoints: 2 to 14
    • Primary completion date: Oct 2029 to Jan 2030
    • Study completion date: Oct 2030 to Jan 2031
    • Eligibility criteria revised
    • Secondary endpoints shortened, about 13 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to and in early pregnancy, can reduce the risk and severity of Hyperemesis Gravidarum (HG), a severe nausea and vomiting condition in pregnancy, in individuals aged 18-49 who have experienced HG in a previous pregnancy and are trying to conceive. Researchers also aim to better understand which individuals may respond well - or poorly - to metformin based on biological and clinical characteristics. The main questions this study aims to answer are: 1. Is metformin-XR well-tolerated when taken by non-pregnant individuals who have had HG in a previous pregnancy and are currently trying to conceive? 2. How safe and tolerable is metformin-XR when taken at increasing doses over an 8-week titration period and continued through early pregnancy (or for up to 12 months after reaching maintenance dose if pregnancy does not occur)? 3. Among those who become pregnant during the study, does pre-pregnancy metformin-XR use reduce the risk of HG coming back and lower the severity of nausea and vomiting symptoms? 4. How does pre-pregnancy metformin-XR use affect pregnancy outcomes, postpartum health, and newborn health and development? 5. Are there specific genetic, biomarker, demographic, or clinical features that predict whether someone is likely to benefit from metformin-XR or experience side effects that lead them to stop taking it? Researchers will compare a metformin treatment group to a survey-only group (comparator, no study drug) to see if metformin-XR is associated with improved outcomes, including reduced HG recurrence and better maternal and neonatal health indicators. Participants will: Complete online questionnaires before pregnancy, during early pregnancy, and postpartum (Treatment group only) Take daily metformin-XR and attend three brief study visits (Treatment group only) Undergo blood draws at specified timepoints to assess safety and biological response
Trial Details
NCT Number NCT07129473
Lead Sponsor University of Southern California
Collaborators: The Morning Sickness & HG Clinic
Conditions
(from sponsor)		 Hyperemesis Gravidarum
Related terms Hyperemesis Gravidarum, Morning Sickness, Nausea, Vomiting
Enrollment 224 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov