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RECRUITING

NCT06615843

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-30

Completion Date

2027-07-30

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Genital Diseases, Female Ectopic Pregnancy Uncertain Viability of Pregnancy Abortion, Missed Hyperemesis Gravidarum

Interventions

DEVICE

Participants will receive post-emergency gynecological follow-up at home using a connected health app

The 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

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 \&lt; 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \&lt; 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 \&lt; 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

Locations (1)

Hôpital Cochin

Paris, France