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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 24, 2024

Keywords

ClinConnect Summary

The GYNAB study is a clinical trial that is looking at two ways of providing follow-up care for women who have recently experienced gynecological emergencies, like ectopic pregnancies or miscarriages. The trial will compare the use of a connected health app, which allows patients to track their symptoms and communicate with their healthcare team, to traditional in-person follow-up visits. The main goal is to see which method makes patients more satisfied with their care after 7 days, and also to check how they feel about their care after 28 days. Researchers hope that using the app will not only improve patient experiences but also decrease the number of hospital visits and still provide the same level of care.

To participate in this study, women aged 18 to 60 who need follow-up care for specific conditions, such as genital infections, non-complicated ectopic pregnancies, or severe vomiting during early pregnancy, may be eligible. However, those with serious health issues, language barriers, or difficulties using digital technology will not be included. If chosen for the study, participants will either use the app for their follow-up care or continue with the usual in-person visits, and they will be asked to share their experiences and outcomes throughout the process. This trial could help improve how follow-up care is offered in the future, especially in the digital age.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged ≥ 18 and ≤ 60 years
• • First-time consultation at gynecological emergencies within the past three months
• * Requires post-emergency follow-up for one of the following clinical conditions:
• • Genital Infections (IGH): Acute pelvic pain with 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 \< 100/85 mmHg and FC ≥ 100 bpm)
• • Abdominal defense or contracture
• • Pain not controlled by level 1 analgesics (EVA \> 7)
• • Severe dehydration defined by \> 10% body weight loss
• • 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