Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Sponsor: Assistance Publique - Hôpitaux de Paris
Trial Details
| Condition | Genital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy, Abortion, Missed, Hyperemesis Gravidarum |
| Intervention | Participants will receive post-emergency gynecological follow-up at home using a connected health app |
| Phase | NA |
| Status | Recruiting |
| Participants | 200 |
| Est. Completion | 30 June 2027 |
| Last Updated | 21 Apr 2026 |
Primary Outcome
Overall Patient Satisfaction
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Women aged 18 and 60 years * No consultation at the gynecological emergency department in the previous month and/or for the same pregnancy. * Requires post-emergency follow-up for one of the following clinical conditions: * Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment * Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \&lt; 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \&lt; 5000, compliant patient, no contraindications for Methotrexate * Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG \&lt; 1500 IU * 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 * First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability * Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up Exclusion Criteria: * Severe clinical intolerance, defined by: * Signs of severe sepsis with unstable hemodynamics (TA with SBP \< 90 mmHg and FC ≥ 105 bpm) * Abdominal defense or contracture * Pain not controlled by level 1 analgesics (EVA \<7) * Severe dehydration defined by a body weight loss of more than 10% * Total food intolerance due to vomiting necessitating hospitalization * Uncontrolled active hemorrhage * Significant ultrasound findings: * Tubo-ovarian abscess ≥ 3 cm * Significant intra-abdominal effusion * Non-French speaking patients * Inability to download or use the digital application due to precarious or isolated digital circumstances * Refusal to sign consent form * Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship) * Patients not affiliated with a social security system
Trial Sites
Countries
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