An interventional study of Participants will receive post-emergency gynecological follow-up at home using a connected health app in Genital Diseases, Female, Ectopic Pregnancy and Uncertain Viability of Pregnancy, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
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.
Scientific Justification:
Emergency gynecological consultations are frequent reasons for hospital visits. Some clinical situations require scheduled follow-up to assess the progression of the initial condition through targeted questioning and additional tests such as blood work or pelvic ultrasounds. Digital health platforms, utilizing AI algorithms, have proven valuable in telehealth, appointment scheduling, personalized care, and prevention. These platforms allow secure, asynchronous follow-up, potentially enhancing patient experience and reducing unnecessary hospital visits.
Platform Capabilities: The secure platforms offer features like messaging, video consultations, document scanning, smart medical note-taking, shared medical records, structured questionnaires, and automatic extraction of standardized medical information from consultations, lab results, and other medical documents. Using machine learning, these platforms assist in structuring medical decisions while enabling patients to be active participants in their care.
Evaluation Criteria:
Post-emergency gynecological follow-up is not standardized. Iterative, unscheduled emergency visits can indicate poor care quality, though repeated scheduled visits are sometimes necessary for follow-up and not indicative of poor quality. Patient satisfaction, measured using validated tools like PROMs (Patient-Reported Outcome Measures), is a useful criterion for evaluating care quality. PROMs are increasingly used to assess healthcare quality and patient management, and their digitized, secure, and easily accessible formats allow efficient and standardized data collection.
PROM-ED Questionnaire:
A validated Canadian PROM-ED questionnaire evaluates patient experiences and satisfaction with emergency care, focusing on symptom relief, understanding, reassurance, and care planning. This standardized tool is appropriate for evaluating satisfaction with emergency gynecological care.
Hypothesis:
We hypothesize that dematerialized follow-up using a connected health app will improve patient experience, reduce hospital visits, and lower hospitalization rates compared to traditional follow-up.
Primary Objective:
Compare overall patient satisfaction between dematerialized post-emergency follow-up at home using a health app and traditional in-person follow-up at the hospital seven days after the initial consultation. Satisfaction will be assessed on a scale from 0 to 10, considering symptom management, follow-up quality, and task performance.
Secondary Objectives:
Design: Randomized superiority trial involving women aged 18-60 consulting for specific gynecological conditions requiring post-emergency follow-up. Inclusion criteria are women aged 18-60 needing specified follow-up. Exclusion criteria are severe clinical intolerance, significant ultrasound findings, non-French speakers, and inability to use digital applications.
Intervention Group: Uses a connected health app for data collection and communication, logging symptoms and test results, with medical team notifications for urgent updates. Patients will record vital signs at nearby pharmacies and log symptoms like pain, bleeding, and vomiting.
Control Group: Receives traditional in-person follow-up with scheduled consultations and emergency contact information.
Data Collection and Randomization: Patients will be randomized into either the intervention or control group. Data will be collected via secure digital platforms, with follow-up evaluations at days 7 and 28. Clinical data will be pseudonymized and securely stored.
Expected Benefits: Improved patient coordination and care efficiency, reduced hospital visits, enhanced access to care, and reduced healthcare costs. The study aims to validate the feasibility and effectiveness of digital health solutions in post-emergency gynecological care. If successful, this could lead to broader adoption of such technologies in various medical fields.
Risks: The study poses minimal risks as it includes patients with stable conditions and ensures continuous monitoring through digital platforms with emergency response capabilities.
Participants: 200 women (100 per group) will be included, based on previous satisfaction scores. Inclusion criteria ensure patient stability and ability to use the digital platform.
Duration: Inclusion will last 24 months, with a 28-day follow-up period for each patient.
Statistical Analysis: Conducted by the statistical team led by Prof. Pierre-Yves Ancel at Université de Paris.
Funding: Private funding by NABLA (40%) and public funding by BPI (60%).
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
This study's planned enrollment of 200 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Requires post-emergency follow-up for one of the following clinical conditions:
Exclusion Criteria:
Severe clinical intolerance, defined by:
Significant ultrasound findings:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive traditional in-person follow-up at the hospital. They will have scheduled consultations at the emergency department where they will undergo necessary evaluations and receive instructions for follow-up visits. Contact information for urgent needs will also be provided, allowing patients to reach medical services 24/7 if required
Participants in this arm will receive post-emergency gynecological follow-up at home using a connected health app.
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
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.
Time frame: 7 days after initial emergency gynecological consultation
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.
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Symptom Relief
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Symptom Relief at 28 Days
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Understanding
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Understanding at 28 days
Patient-reported outcome measure for symptom relief, assessed using the PROM-ED questionnaire.
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Reassurance
Patient-reported outcome measure for reassurance and comfort with their care, assessed using the PROM-ED questionnaire.
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Reassurance at 28 days
Patient-reported outcome measure for reassurance and comfort with their care, assessed using the PROM-ED questionnaire.
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Care Planning
Patient-reported outcome measure for the effectiveness of care planning, assessed using the PROM-ED questionnaire.
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Care Planning at 28 days
Patient-reported outcome measure for the effectiveness of care planning, assessed using the PROM-ED questionnaire.
Time frame: 28 days after initial emergency gynecological consultation
Hospitalization rate
The rate of hospital admissions among participants during the study period.
Time frame: 28 days after initial emergency gynecological consultation
Unscheduled Emergency Consultations
Rate of unscheduled emergency consultations during the follow-up period.
Time frame: 28 days after initial emergency gynecological consultation
Surgical Intervention Rate
Rate of surgical interventions among participants during the study period.
Time frame: 28 days after initial emergency gynecological consultation
Total Hospital Time
Total time spent in the hospital by participants during the study period.
Time frame: 28 days after initial emergency gynecological consultation
Physician Satisfaction
Measure of physician satisfaction with patient management, assessed on a scale from 0 to 10.
Time frame: 28 days after initial emergency gynecological consultation
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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