Metformin for Severe Nausea and Vomiting in Pregnancy
What You Need to Know Before You Apply
What is the purpose of 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 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
Who Is on the Research Team?
Marlena Fejzo, PhD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for women aged 18-49 who had severe nausea and vomiting (HG) needing IV fluids in a past pregnancy, are trying to conceive, live in California or Alabama (for the treatment group), have normal blood tests and kidney function, and are willing to take daily medication before pregnancy.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Metformin Extended Release Oral Tablet
Trial Overview
The study compares daily metformin extended-release tablets started before conception through early pregnancy versus no drug. It aims to see if metformin can lower the risk or severity of HG returning, with participants randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treatment Arm (N=112): * Individuals with a prior HG pregnancy with intravenous (IV) fluid treatment and current pregnancy intent * Residing in California or Alabama * Daily metformin-XR, escalated from 500 mg to 2000 mg (or maximum tolerated dose) over an 8-week titration period, as tolerated * Continue treatment until either 2 weeks post-pregnancy confirmation (early pregnancy) or up to 12 months from the maintenance dose following cessation of birth control/contraceptive device if pregnancy does not occur
Survey/Comparator Arm (N=112): * Matched controls (race/ethnicity, parity, maternal age, prior HG pregnancy (IV fluids), pregnancy intent) * No metformin treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
The Morning Sickness & HG Clinic
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.