Hyperemesis Gravidarum Risk Reduction With Metformin

Recruiting Phase 1 Phase 2 Interventional Study
Hyperemesis Gravidarum
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 49
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
224 (estimated)
Sponsor
University of Southern California · Other
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About This Trial
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 u…
Trial Locations
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Eligibility Criteria
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 to…
Contacts

Marlena Fejzo, PhD

310-383-3581

Marlena.Fejzo@med.usc.edu

CONTACT

Andrew Housholder, MD, FACEP

205-772-9595

CONTACT