[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperemesis-gravidarum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperemesis-gravidarum":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100563413","randomized-study-of-a-dematerialized-management-for-post-emergency-gynecological-follow-up-100563413",false,"NCT06615843","Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up","GYNAB","Inclusion Criteria:\n\n* Women aged 18 and 60 years\n* No consultation at the gynecological emergency department in the previous month and\u002For for the same pregnancy.\n* Requires post-emergency follow-up for one of the following clinical conditions:\n\n  * Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment\n  * Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \\< 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \\< 5000, compliant patient, no contraindications for Methotrexate\n  * Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG \\< 1500 IU\n  * Missed Miscarriage (GAM): Confirmed by an intrauterine gestational sac ≥ 25mm without an embryo or an intrauterine gestational sac with an embryo ≥ 7mm without visible cardiac activity, treated with Misoprostol\n  * First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability\n  * Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up\n\nExclusion Criteria:\n\n* Severe clinical intolerance, defined by:\n\n  * Signs of severe sepsis with unstable hemodynamics (TA with SBP \\\u003C 90 mmHg and FC ≥ 105 bpm)\n  * Abdominal defense or contracture\n  * Pain not controlled by level 1 analgesics (EVA \\\u003C7)\n  * Severe dehydration defined by a body weight loss of more than 10%\n  * Total food intolerance due to vomiting necessitating hospitalization\n  * Uncontrolled active hemorrhage\n* Significant ultrasound findings:\n\n  * Tubo-ovarian abscess ≥ 3 cm\n  * Significant intra-abdominal effusion\n* Non-French speaking patients\n* Inability to download or use the digital application due to precarious or isolated digital circumstances\n* Refusal to sign consent form\n* Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship)\n* Patients not affiliated with a social security system","FEMALE","18 Years","60 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up. Conducted by Drs. Laëtitia CAMPIN and Louis MARCELLIN at Hôpital Cochin, it is sponsored by Assistance Publique - Hôpitaux de Paris. The main objective is to assess patient satisfaction at day 7 on a scale from 0 to 10, considering symptom management, follow-up quality, and task performance. Secondary objectives include comparing satisfaction at day 28, PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28, hospitalization rates, unscheduled consultations, surgical interventions, total hospital time by day 28, and physician satisfaction at 28 days. This randomized trial involves women aged 18-60 needing follow-up for conditions like genital infections, non-complicated ectopic pregnancies, unlocated pregnancy, first trimester metrorrhagia, miscarriages , and severe vomiting before 12 weeks. Inclusion criteria are women aged 18-60 needing specified follow-up. Exclusion criteria are severe clinical intolerance, severe criteria ultrasound findings, non-French speakers, and inability to use digital applications. The intervention group uses a connected health app for data collection and communication, logging symptoms and test results, with medical team notifications for urgent updates. The control group receives traditional in-person follow-up with scheduled consultations and emergency contact information. The study hypothesizes that digital follow-up will improve patient experience, reduce hospital visits, and provide comparable or superior satisfaction and clinical outcomes. The results could promote broader digital health adoption in various medical fields.",[27,28,29,30,31],"Genital Diseases, Female","Ectopic Pregnancy","Uncertain Viability of Pregnancy","Abortion, Missed","Hyperemesis Gravidarum",[33,34,35,36,37,38,39],"Gynecological Emergencies","Post-Emergency Follow-Up","Patient-Reported Outcome Measures (PROMs)","Digital Health","Patient satisfaction","Telehealth","Asynchronous Medical Follow-up","RECRUITING","2026-04-20",{"date":43,"type":44},"2026-04-21","ACTUAL",{"date":46,"type":44},"2025-06-30",{"date":48,"type":21},"2027-07-30",{"name":50,"class":51},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100602896","phase-2-hyperemesis-gravidarum-risk-reduction-with-metformin-100602896","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,"49 Years",{"count":62,"type":21},224,[64],"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",[31],[68,69,70,31,71,72,73,74,75,76,77,78,79],"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":83,"type":44},"2025-12-11",{"date":85,"type":21},"2026-01",{"date":87,"type":21},"2031-01",{"name":89,"class":51},"University of Southern California",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":52},"100575491","tablet-ginger-versus-tablet-doxylamine-succinate-in-control-of-nausea-and-vomiting-in-pregnancy-100575491","NCT06772974","Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy","Comparison of Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy","GDNVP","Inclusion Criteria:\n\n* Pregnant women age\\>18 years\n* 5 to 8weeks of gestation and 8+1to11weeks\n* Attending OPD with signs and symptoms of nausea and vomiting with ultrasound confirmed pregnancy\n* 1st and 2nd gravida\n* Patients who will give consent\n\nExclusion Criteria:\n\n* Patients were hospitalized for Hyperemesis Gravidarum\n* Medical disorders like Diabetes Mellitus, Hepatic, Gastric, Pancreatic, Pyelonephritis, Thyroid and Psychological Disorder\n* Patients not responding to treatment after 1week will be excluded\n* Patients who will not give consent",{"count":99,"type":21},66,[24],"Nausea and vomiting are common GI symptoms of pregnancy. Multiple managing options have been used for NVP. Doxylamine succinate is used as first line treatment for NVP despite that alternative modalities such as ginger extracts and tablets is being explored.\n\nThis RCT will be conducted after taking ethical approval and informed consent, in Department of Gynecology, Aziz Bhatti Shaheed teaching hospital, Gujrat. Patients will be divided into two equal groups. One group will receive tablet ginger while other group will receive Doxylamine succinate tablets. Baseline PUQE score (3- 15 point scale) over 24 hour will be noted according to symptoms of nausea and vomiting following 7 days of treatment and then at 2nd and 3rd week. Comparison of the change in the severity of nausea from baseline scores (Post-therapy PUQE score - base line scores) in both groups will be considered for results.",[103,31],"Nausea Gravidarum",[75,76,77],"2025-01-15",{"date":107,"type":44},"2025-01-17",{"date":105,"type":21},{"date":110,"type":21},"2025-07-15",{"name":112,"class":51},"Nawaz Sharif Medical College"]