Genital Diseases, FemaleGYNABNCT06615843
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
A study testing Participants will receive post-emergency gynecological follow-up at home using a connected health app in people with Genital Diseases, Female and Ectopic Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Genital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy
- What is being tested?
- Participants will receive post-emergency gynecological follow-up at home using a connected health app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin
Paris, 75014
Laetitia CAMPAIN, MD, PhD, 33+0158413680, laetitia.campain@aphp.fr
Laetitia CAMPAIN, MD, PhD
About this study
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.
Read the detailed description
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:
- Compare satisfaction at 28 days.
- Evaluate PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28.
- Assess hospitalization rates by day 28.
- Assess unscheduled emergency consultations during the study.
- Assess surgical intervention rates by day 28.
- Assess total hospital time by day 28.
- Evaluate physician satisfaction at 28 days.
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%).
- Conditions
- Genital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy, Abortion, Missed, Hyperemesis Gravidarum
- Being tested
- Participants will receive post-emergency gynecological follow-up at home using a connected health app
- Keywords
- Gynecological Emergencies, Post-Emergency Follow-Up, Patient-Reported Outcome Measures (PROMs), Digital Health, Patient satisfaction, Telehealth, Asynchronous Medical Follow-up
- Medical subject headings
- Genital Diseases, Female, Pregnancy, Ectopic, Abortion, Missed, Hyperemesis Gravidarum, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive post-emergency gynecological follow-up at home using a connected health appDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Traditional In-Person Follow-Up | No intervention | 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 |
| Dematerialized Follow-Up | Experimental | Participants in this arm will receive post-emergency gynecological follow-up at home using a connected health app. Receives: Device: Participants will receive post-emergency gynecological follow-up at home using a connected health app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after initial emergency gynecological consultation
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days after initial emergency gynecological consultation
Hospitalization rate
The rate of hospital admissions among participants during the study period.
Measured: 28 days after initial emergency gynecological consultation
Unscheduled Emergency Consultations
Rate of unscheduled emergency consultations during the follow-up period.
Measured: 28 days after initial emergency gynecological consultation
Surgical Intervention Rate
Rate of surgical interventions among participants during the study period.
Measured: 28 days after initial emergency gynecological consultation
Total Hospital Time
Total time spent in the hospital by participants during the study period.
Measured: 28 days after initial emergency gynecological consultation
Physician Satisfaction
Measure of physician satisfaction with patient management, assessed on a scale from 0 to 10.
Measured: 28 days after initial emergency gynecological consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Diseases, FemaleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Louis MARCELLIN, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisLaetitia CAMPIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615843
- Sponsor's protocol ID
- APHP230586
- Other IDs
- 2023-A02336-39
- Acronym
- GYNAB
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
- ClinicalTrials.gov ID
- NCT06615843
- Acronym / sponsor ID
- GYNAB / APHP230586
- Conditions
- Genital Diseases, Female, Ectopic Pregnancy, Uncertain Viability of Pregnancy, Abortion, Missed, Hyperemesis Gravidarum
- Keywords
- Gynecological Emergencies, Post-Emergency Follow-Up, Patient-Reported Outcome Measures (PROMs), Digital Health, Patient satisfaction, Telehealth, Asynchronous Medical Follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Compare satisfaction at 28 days.
- Evaluate PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28.
- Assess hospitalization rates by day 28.
- Assess unscheduled emergency consultations during the study.
- Assess surgical intervention rates by day 28.
- Assess total hospital time by day 28.
- Evaluate physician satisfaction at 28 days.
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%).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional In-Person Follow-Up | No intervention | –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 |
| Dematerialized Follow-Up | Experimental | Device: Participants will receive post-emergency gynecological follow-up at home using a connected health appParticipants in this arm will receive post-emergency gynecological follow-up at home using a connected health app. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (15 listed)
- Severe clinical intolerance, defined by:
- Significant ultrasound findings:
- Non-French speaking patients
- Inability to download or use the digital application due to precarious or isolated digital circumstances
- Refusal to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will receive post-emergency gynecological follow-up at home using a connected health appThe 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 | Device | Dematerialized Follow-Up |
Primary outcome
Overall Patient Satisfaction
Time frame: 7 days after initial emergency gynecological consultation
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.
14 secondary outcomes
Overall Patient Satisfaction at 28 Days
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Symptom Relief
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Symptom Relief at 28 Days
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Understanding
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Understanding at 28 days
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Reassurance
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Reassurance at 28 days
Time frame: 28 days after initial emergency gynecological consultation
PROM-ED Score for Care Planning
Time frame: 7 days after initial emergency gynecological consultation
PROM-ED Score for Care Planning at 28 days
Time frame: 28 days after initial emergency gynecological consultation
Hospitalization rate
Time frame: 28 days after initial emergency gynecological consultation
Unscheduled Emergency Consultations
Time frame: 28 days after initial emergency gynecological consultation
Surgical Intervention Rate
Time frame: 28 days after initial emergency gynecological consultation
Total Hospital Time
Time frame: 28 days after initial emergency gynecological consultation
Physician Satisfaction
Time frame: 28 days after initial emergency gynecological consultation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis MARCELLIN, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Laetitia CAMPIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants will receive post-emergency gynecological follow-up at home using a connected health app in people with Genital Diseases, Female and Ectopic Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia CAMPIN, MD (33 015413680, laetitia.campin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Patient Satisfaction (time frame: 7 days after initial emergency gynecological consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.