Remote follow-up with a connected app after emergency gynecological care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares dematerialized (app-based) post-emergency gynecological follow-up to standard in-person visits for adult women treated at Hôpital Cochin. Participants are randomized to receive structured follow-up via a secure connected health platform with PROM questionnaires and clinician messaging, or routine outpatient clinic follow-up. The primary outcome is patient satisfaction at day 7 on a 0–10 scale, with secondary outcomes including PROM-ED domain scores at days 7 and 28, rates of hospitalization, unscheduled consultations, surgical interventions, and total hospital time by day 28. The trial enrolls women with common post-emergency conditions such as genital infections, uncomplicated ectopic pregnancy, uncertain early pregnancy viability, missed miscarriage, and related first-trimester issues.

Why it matters

Who can join: the full rules

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 \< 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \< 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 \< 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

Where it's running

• Hôpital Cochin
  Paris, France Recruiting

Study contacts

• Principal investigator: Laetitia CAMPIN, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Laetitia CAMPIN, MD
• Email: laetitia.campin@aphp.fr
• Phone: 33 015413680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.