Condition: Hyperemesis Gravidarum · Sponsor: University of Southern California
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…
This description comes directly from the study's public registry record.
Marlena Fejzo, PhD · 310-383-3581 · Marlena.Fejzo@med.usc.edu
Andrew Housholder, MD, FACEP · 205-772-9595
Always discuss trial participation with your own doctor first.
| The Morning Sickness & HG Clinic | Birmingham, Alabama, United States | Not Yet Recruiting |
| University of Southern California - Keck School of Medicine | Los Angeles, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07129473