[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uncertain-viability-of-pregnancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uncertain-viability-of-pregnancy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":5},"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"]