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 - Hôp
| Condition(s) | Genital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy, Abortion, Missed, Hyperemesis Gravidarum |
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| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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): |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Paris, France |
| Start date | 2025-06-30 |
| NCT ID | NCT06615843 |
| Official listing | https://clinicaltrials.gov/study/NCT06615843 |