[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602896":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":70,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":18,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":18,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":57,"whyStopped":18,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"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 (or maximum tolerated dose) over an 8-week titration period, as tolerated\n* 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\u002Fcontraceptive device if pregnancy does not occur",[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) once daily with an evening meal starting prior to conception. Daily dosing will begin at 500 mg and increase gradually over an 8-week period (+500 mg every 2 weeks, as tolerated, with increases, holds, or reductions based on symptom severity) to a maximum dose of 2,000 mg. Treatment at highest tolerated dose will continue until 2 weeks after positive pregnancy test or 12 months after cessation of birth control\u002Fcontraceptive device. 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. Postpartum surveys include a metformin treatment \\& HG outcomes survey (REDCap) and additional measures (PES, MAPP-QOL, EPDS, PSAS, and ASQ-3).",[9],[26],{"name":27,"affiliation":5,"role":28},"Marlena Fejzo, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","310-383-3581","Marlena.Fejzo@med.usc.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":18},"Andrew Housholder, MD, FACEP","205-772-9595",[38,55],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The Morning Sickness & HG Clinic","NOT_YET_RECRUITING","Birmingham","Alabama","35223","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-86.80249,33.52066,{"lat":50,"lon":49},[53],{"name":35,"role":31,"phone":36,"phoneExt":18,"email":54},"admin@morningsicknessclinic.com",{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University of Southern California - Keck School of Medicine","RECRUITING","Los Angeles","California","90033",{"type":47,"coordinates":62},[63,64],-118.24368,34.05223,{"lat":64,"lon":63},[67],{"name":68,"role":31,"phone":32,"phoneExt":18,"email":69},"Marlena S Fejzo, PhD","marlena.fejzo@med.usc.edu",{"type":28,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marlena Fejzo","Clinical Assistant Professor of Population and Public Health Sciences in the Center for Genetic Epidemiology",[74],{"name":39,"class":75},"UNKNOWN","100602896","phase-1-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* 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.\n* Under care of a personal OB\u002FGYN or willing to establish care with a personal OB\u002FGYN before study start\n* Ownership of a personal scale (or willingness to obtain one for study use)\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 to mildly decreased creatinine levels (estimated GFR \\> 60 mL\u002Fmin\u002F1.73m²)\n* Survey\u002FComparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy\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* English speaking\n* Regular cycles\n\nExclusion Criteria:\n\n* Allergic or adverse reaction to metformin-XR\n* Thalassemia\n* Cirrhosis and\u002For hepatic impairment\n* Decompensated heart failure\n* Daily\u002Fregular use of medications\u002Fsubstances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix)\n* Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication\n* Assisted Reproductive Technology\n* Excess alcohol consumption (\\> 7 standard drinks per week on average)\n* Pregnant\n* Not trying to conceive\n* Treatment Arm: Residing outside California\u002FAlabama\n* Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range)\n* Treatment Arm: abnormal creatinine levels (estimated GFR \\\u003C 60 mL\u002Fmin\u002F1.73m² excluded from the study, signs of kidney disease)\n* Treatment Arm: current metformin use\n* Survey\u002FComparator Arm: current metformin use or plans to take metformin prior to pregnancy\n* Any medical\u002Fsurgical condition that the investigator feels would compromise the participant's participation in the study\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.\n* Not english speaking\n* Irregular cycles\n* Not willing to refrain from trying to conceive\u002Fuse birth control or contraceptive device until maintenance dose.",true,"FEMALE","18 Years","49 Years",{"count":87,"type":88},224,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE1","PHASE2","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.\n\nThe main questions this study aims to answer are:\n\n1. 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?\n2. 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)?\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, no study drug) 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",[95],"Hyperemesis Gravidarum",[97,98,99,95,100,101,102,103,104,105,106,107,108],"Metformin","HG","Hyperemesis","Nausea and Vomiting of Pregnancy","NVP","severe Nausea and Vomiting of Pregnancy","sNVP","Nausea","Vomiting","Pregnancy","Pregnant","Morning Sickness","2026-07-20",{"date":111,"type":112},"2026-07-22","ACTUAL",{"date":114,"type":112},"2026-07-13",{"date":116,"type":88},"2031-03",{"name":5,"class":6},2]