Remote follow-up with a connected app after emergency gynecological care
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
This trial tests if using a secure connected health app for remote follow-up improves satisfaction and clinical outcomes for women aged 18–60 after emergency gynecological visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Paris) |
| Trial ID | NCT06615843 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18–60 who require scheduled post-emergency gynecological follow-up for conditions like genital infection, non-complicated ectopic pregnancy, early pregnancy of uncertain viability, or missed miscarriage, who were seen at the participating center and can use a smartphone app, are ideal candidates.
Not a fit: Patients with unstable or complicated conditions requiring immediate in-person assessment or procedures, those without smartphone/internet access, or those unable to engage with digital follow-up are unlikely to benefit from the remote pathway.
Why it matters
Potential benefit: If successful, the app-based pathway could increase patient satisfaction, reduce unnecessary hospital visits, and streamline follow-up care.
How similar studies have performed: Telehealth and digital follow-up programs have improved patient satisfaction and reduced visits in other emergency and post-procedure settings, but randomized evidence specifically for post-emergency gynecological follow-up is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.