RecruitingNAINTERVENTIONAL

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

This study, called GYNAB, is checking if a new way of managing follow-up after a gynaecological emergency is better for patients. Instead of coming back to the hospital, some women will use a special health app on their phone or tablet to keep track of their symptoms and talk to doctors from home. Others will have their usual in-person hospital visits. Doctors want to see if using the app makes patients happier and helps them recover well, compared to traditional hospital visits. The study is run by doctors at Hôpital Cochin in Paris and is for women aged 18 to 60 who need follow-up for conditions like infections, ectopic pregnancies, or severe morning sickness.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

200

Start

30 Jun 2025

Estimated completion

30 Jul 2027

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

What is this study about?

When you have a gynaecological emergency, you might need more check-ups afterwards to make sure you're recovering well. These follow-up appointments usually mean going back to the hospital in person. This study, called GYNAB, is looking at a new idea: what if you could have some of these follow-ups from the comfort of your own home, using a special health app?

The main goal of this study is to see if women who use this app for their follow-up are as happy, or even happier, with their care compared to those who have the usual in-person appointments. The app would allow you to record your symptoms and test results, and healthcare professionals would monitor your progress. The doctors also want to find out if using the app helps you feel better, understand your care, and avoid unnecessary trips to the hospital. They'll also be looking at how many people need to go back to the hospital or have surgery.

This research is important because if using a health app works well and patients are happy with it, it could change how medical follow-up is done in the future, making healthcare more convenient for many people in different areas of medicine. It's about finding ways to provide good care that fits better into people's lives.

Key takeaways

Compares app-based home care to traditional hospital follow-up.
Aims to improve patient satisfaction and convenience.
For women aged 18-60 with specific gynaecological emergencies.
Involves using a health app for symptom tracking and communication, or traditional appointments.
Helps understand if digital health can offer effective post-emergency care.
Participation lasts for 28 days.

Who may be eligible?

This study is looking for women aged between 18 and 60 years old. You might be able to take part if you have recently had a gynaecological emergency and need follow-up care for certain conditions. These conditions include some genital infections handled with antibiotics, specific types of ectopic pregnancies (where the pregnancy develops outside the womb), early pregnancies where it's unclear if the baby will develop, miscarriages managed with medication, some cases of bleeding in early pregnancy, and severe morning sickness before 12 weeks that needs follow-up.

However, you won't be able to join if your condition is very serious and needs immediate, intense hospital care, or if doctors find certain significant issues on your ultrasound scan. Also, if you don't speak French or if you would find it difficult to use a digital app for your care, you won't be able to take part. Finally, if you've already had a gynaecological emergency consultation in the last month for the same issue, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 60 years old?
Do you need follow-up care after a recent gynaecological emergency?
Is your condition one of the specified types (e.g., certain infections, ectopic pregnancy, miscarriage, severe vomiting)?
Are you able to speak French?
Are you able to use a digital app on a phone or tablet?
Have you NOT had a gynaecological emergency consultation for the same issue in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be placed into one of two groups by chance – like flipping a coin. One group will receive their follow-up care using a special health app on a digital device. This means you'll use the app to record your symptoms, log any test results, and communicate with the medical team from home. The medical team will be alerted if there are any urgent updates from you. The other group will receive the standard follow-up care, which involves scheduled in-person appointments at the hospital and ways to contact the emergency services if needed. The study will last until 28 days after your emergency visit. Throughout this time, doctors will ask you questions about how you feel and your satisfaction at day 7 and 28. They'll also monitor things like any further hospital visits or surgeries.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of more convenient follow-up care from home if you are in the app group, which might reduce the need for hospital travel and waiting times. You would also have regular communication with medical staff through the app. For those in the standard care group, you'll receive the established follow-up care. There are no direct medical risks from the app itself, but any medical treatment you receive, whether through the app or in person, carries its usual risks, which your doctor will discuss with you. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

Hôpital Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'dematerialized management' follow-up?

It means having your follow-up care done online or through an app, rather than always going to the hospital in person.

What kind of app will I be using?

It's a connected health app designed for you to record symptoms, test results, and communicate securely with your medical team from home.

Will I still see a doctor if I'm in the app group?

Yes, the app allows you to communicate with the medical team, and they will be alerted to any urgent updates you provide. Appointments will be managed through the app, but some may still be in person if medically necessary.

What if I can't use digital apps easily?

If you find it difficult to use digital applications, you would not be able to participate in this particular study.

How long will I be in the study?

Your participation in the study will last for 28 days after your initial emergency visit.

How to find out more

Laetitia CAMPIN, MD

laetitia.campin@aphp.fr 33 015413680 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.