[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602896":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":34,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":18,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":18},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Treatment Arm (N=112):\n\n* Individuals with a prior HG pregnancy with intravenous (IV) fluid treatment and current pregnancy intent\n* Residing in California or Alabama\n* Daily metformin-XR, escalated from 500 mg to 2000 mg as tolerated\n* Continue treatment until either 2 weeks post-pregnancy confirmation or up to 12 months",[13],"Drug: Metformin Extended Release Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Survey\u002FComparator Arm","NO_INTERVENTION","Survey\u002FComparator Arm (N=112):\n\n* Matched controls (race\u002Fethnicity, parity, maternal age, prior HG pregnancy (IV fluids), pregnancy intent)\n* No metformin treatment",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Metformin Extended Release Oral Tablet","Participants in the Treatment Arm will receive oral extended-release metformin (metformin-XR) 1x daily with an evening meal starting prior to conception. Daily dosing will begin at 500 mg and increase gradually over an 8 week period (+500mg every 2 weeks, as tolerated) to a maximum tolerated dose of up to 2,000 mg. Treatment at highest tolerated dose will continue until either 2 weeks after a positive pregnancy test or 12 months from treatment start, whichever comes first. Participants will attend 3 clinic visits and provide blood samples at baseline, after dose escalation, and during early pregnancy to assess biomarker levels and genetic characteristics. Daily dosing, adherence, and side effects are recorded via MyCap; clinical visits include vital signs, PUQE-24\u002FHELP scores, and blood draws (CBC, creatinine, genotyping, biomarker levels). Postpartum surveys include a metformin treatment \\& HG outcomes survey (REDCap) and additional measures (PES, MAPP-QOL, EPDS, PSAS, and ASQ-3).",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Marlena Fejzo, PhD","CONTACT","310-383-3581","Marlena.Fejzo@med.usc.edu",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":18},"Andrew Housholder, MD, FACEP","205-772-9595",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Marlena Fejzo","Clinical Assistant Professor of Population and Public Health Sciences in the Center for Genetic Epidemiology",[39],{"name":40,"class":41},"The Morning Sickness & HG Clinic","UNKNOWN","100602896","phase-2-hyperemesis-gravidarum-risk-reduction-with-metformin-100602896",false,"NCT07129473","Hyperemesis Gravidarum Risk Reduction With Metformin","Inclusion Criteria:\n\n* Ages 18-49\n* HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment)\n* Trying to conceive\n* Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy\n* Treatment Arm: residing in California\u002FAlabama\n* Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range)\n* Treatment Arm: normal creatinine levels (GFR \\\u003C 45)\n* Survey\u002FComparator Arm: not currently taking metformin and do not plan to take metformin during study period\n* Able and willing to provide written informed consent prior to initiation of any study procedures.\n* Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Allergic or adverse reaction to metformin-XR\n* Chronic diseases\u002Fconditions\n* Daily medications\u002Fsubstances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other Selective Serotonin Reuptake Inhibitors (SSRIs))\n* Assisted Reproductive Technology\n* Pregnant\n* Not trying to conceive\n* Pre-existing kidney dysfunction\n* Treatment Arm: Residing outside California\u002FAlabama\n* Anemia\n* Treatment Arm: abnormal blood panel (CBC) (e.g., white count, hemoglobin, or platelets not within the normal range)\n* Treatment Arm: abnormal creatinine levels (GFR \\> 45 excluded from the study, signs of kidney disease)\n* Survey\u002FComparator Arm: current metformin use or plans to take metformin during study period\n* Not able and willing to provide written informed consent prior to initiation of any study procedures.\n* Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.",true,"FEMALE","18 Years","49 Years",{"count":53,"type":54},224,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to 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.\n\nThe main questions this study aims to answer are:\n\n1. Is metformin-XR acceptable and well-tolerated when taken by non-pregnant individuals who have had HG in a previous pregnancy and are currently trying to conceive?\n2. How safe and tolerable is metformin-XR when taken at increasing doses over 8 weeks and continued through early pregnancy (or for up to 12 months if pregnancy does not occur)?\n3. 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?\n4. How does pre-pregnancy metformin-XR use affect pregnancy outcomes, postpartum health, and newborn health and development?\n5. 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?\n\nResearchers will compare a metformin treatment group to a survey-only group (comparator) to see if metformin-XR is associated with improved outcomes, including reduced HG recurrence and better maternal and neonatal health indicators.\n\nParticipants will:\n\nComplete online questionnaires before pregnancy, during early pregnancy, and postpartum\n\n(Treatment group only) Take daily metformin-XR and attend three brief study visits\n\n(Treatment group only) Undergo blood draws at specified timepoints to assess safety and biological response",[60],"Hyperemesis Gravidarum",[62,63,64,60,65,66,67,68,69,70,71,72,73],"Metformin","HG","Hyperemesis","Nausea and Vomiting of Pregnancy","NVP","severe Nausea and Vomiting of Pregnancy","sNVP","Nausea","Vomiting","Pregnancy","Pregnant","Morning Sickness","NOT_YET_RECRUITING","2025-12-04",{"date":77,"type":78},"2025-12-11","ACTUAL",{"date":80,"type":54},"2026-01",{"date":82,"type":54},"2031-01",{"name":5,"class":6}]