RecruitingNAINTERVENTIONAL

Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

After an early miscarriage, sometimes a small amount of tissue remains in the womb. This can cause ongoing bleeding and upset. This study, for women aged 18-42, is comparing two common procedures to remove this leftover tissue: hysteroscopy and aspiration. Hysteroscopy uses a small camera to see and remove the tissue, while aspiration gently suctions it out. Doctors don't currently have clear guidelines on which method is better. This research aims to find out which procedure is more effective at removing the tissue, causes fewer complications, and helps women get pregnant again sooner. About 220 women will take part, with half receiving one treatment and half receiving the other.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

220

Start

18 Sep 2023

Estimated completion

01 Jan 2029

Miscarriage

What is this study about?

When a woman has an early miscarriage, it's a very difficult time. Sometimes, after the miscarriage, a small amount of tissue (called 'trophoblastic retention') can be left behind in the womb. This can lead to ongoing bleeding or infection, and can add to the emotional distress. Doctors want to remove this tissue to help women recover and prepare for future pregnancies.

Currently, there are two main ways to remove this leftover tissue: a hysteroscopy or an aspiration. A hysteroscopy involves a doctor using a thin, lighted tube with a camera to look inside the womb and carefully remove the tissue. An aspiration is a procedure where a doctor gently suctions out the tissue. Both are common, but doctors don't yet know if one is clearly better than the other in terms of effectiveness, complications, or helping women get pregnant again.

This study aims to compare these two procedures directly. Researchers want to see which one works best to fully remove the tissue, causes the fewest problems during or after the procedure, and has the best outcomes for women who hope to get pregnant again in the future. By understanding this better, doctors can give clearer advice and help women make the best choices for their care.

Key takeaways

Compares two treatments for tissue left after miscarriage.
Aims to find which treatment is safer and more effective.
Looks at how treatments affect chances of future pregnancy.
Involves either a hysteroscopy or an aspiration procedure.
Study follows participants for up to two years.
Recruiting women aged 18-42 after early miscarriage.

Who may be eligible?

You might be able to join this study if you've recently had an early miscarriage (before 14 weeks of pregnancy), and your doctor has found some tissue still remaining in your womb with an ultrasound scan. It's important that you and your doctor have both agreed that surgery is the right next step for you, and you also wish to try for a pregnancy in the future.

However, you won't be able to join if you have a known problem with the shape of your womb, or if you've already had surgery for this particular issue. Also, if your miscarriage was not natural (for example, if it was a planned termination), or if you had a late miscarriage or have recently given birth, this study isn't for you. You also cannot participate if you currently have an IUCD (coil) fitted, or if your pregnancy was achieved through fertility treatments.

Crucially, you must be between 18 and 42 years old, be able to give your full, informed agreement to take part after thinking it over, and be part of the UK's national health insurance system. If you are already involved in another medical study or need emergency surgery for heavy bleeding, 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 between 18 and 42 years old?
Have you recently had an early miscarriage (under 14 weeks)?
Has an ultrasound shown tissue still in your womb?
Are you and your doctor considering surgical treatment?
Are you hoping to get pregnant again in the future?
Are you covered by a national health insurance system?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to receive either the hysteroscopy or the aspiration procedure. This is like flipping a coin for fairness. Both procedures are standard treatments. After your procedure, doctors will monitor your recovery. You'll have an ultrasound scan about six weeks later to check that all the tissue has been removed. The study will also follow up with you for two years to understand if there are any long-term effects on your health and your ability to get pregnant again. There will be check-ups and possibly follow-up scans during this time.

Potential risks and benefits

Taking part could help improve future care for women in a similar situation, as the study aims to find the most effective and safest treatment. You will receive one of two common, established treatments. As with any medical procedure, there are potential risks like infection, bleeding, or injury to the womb, though these are rare. The study is designed to carefully track and compare any problems that might occur with each method. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

CHU de Bordeaux - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Verified postcode
Montpellier, France· Recruiting
CHU de Nice - Hôpital Archet II
Verified postcode
Nice, France· Not yet recruiting
CHU de Nîmes - Hôpital Carémeau
Verified postcode
Nîmes, France· Recruiting

Common questions

What is 'trophoblastic retention'?

It means some small pieces of tissue from the pregnancy are still left in the womb after a miscarriage.

What is the difference between hysteroscopy and aspiration?

Hysteroscopy uses a camera to see and remove the tissue, while aspiration gently suctions it out.

Will I get to choose which procedure I have?

No, you'll be assigned to one of the two procedures randomly, like drawing lots, to ensure fairness in the study.

How long will I be followed up after the procedure?

The study will follow your progress for up to two years after your procedure to see how you are doing.

Will taking part affect my chance of getting pregnant again?

The study is actually designed to see which procedure gives the best chance of future pregnancy and fertility rates.

How to find out more

Martha DURAES, MD

m-duraes@chu-montpellier.fr +334 67 33 65 32 Official trial record

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