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