RecruitingNot ApplicableNCT06615843

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

200 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Participants will receive post-emergency gynecological follow-up at home using a connected health app for people with abortion, missed, ectopic pregnancy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEParticipants 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


Locations(1)

Hôpital Cochin

Paris, France

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NCT06615843


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