💬In plain words
What the trial is, and whether it could suit you
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 re
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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