RecruitingNANCT06615843

Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up

Sponsor: Assistance Publique - Hôpitaux de Paris

Trial Details

ConditionGenital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy, Abortion, Missed, Hyperemesis Gravidarum
InterventionParticipants will receive post-emergency gynecological follow-up at home using a connected health app
PhaseNA
StatusRecruiting
Participants200
Est. Completion30 June 2027
Last Updated21 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 \&amp;lt; 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \&amp;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 \&amp;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

France
View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service