💬In plain words
What the trial is, and whether it could suit you
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 infe
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📋 Eligibility rules (as published)
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
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