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.
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
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%
Parallel
Participants will receive post-emergency gynecological follow-up at home using a connected health app
DeviceThe app will facilitate data collection and communication, including logging of vital signs, symptoms (such as pain, bleeding, and vomiting), and uploading of test results. Medical professionals will review the health data twice daily and provide care instructions through instant messaging. The app will also alert the medical team of any urgent updates or deviations from expected health patterns
Overall Patient Satisfaction
Measure of overall patient satisfaction with post-emergency gynecological follow-up, assessed on a scale from 0 to 10. This includes symptom management, follow-up quality, and the ability to perform requested tasks.
Overall Patient Satisfaction at 28 Days
Measure of overall patient satisfaction with post-emergency gynecological follow-up, assessed on a scale from 0 to 10 at 28 days. This includes symptom management, follow-up quality, and the ability to perform requested tasks.
PROM-ED Score for Symptom Relief
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
PROM-ED Score for Symptom Relief at 28 Days
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
PROM-ED Score for Understanding
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
