A randomised controlled trial looking at whether adding a drug called mifepristone to standard medical treatment (with a drug called methotrexate) reduces the need for emergency surgery for tubal ectopic pregnancy in women clinically suitable for medical management of tubal ectopic pregnancy
This study is investigating a new way to treat ectopic pregnancy, a condition where a pregnancy grows outside the womb, usually in a fallopian tube. Ectopic pregnancy can be very serious. Currently, a common treatment is an injection called methotrexate, but it doesn't always work perfectly and sometimes surgery is still needed. Researchers are now exploring if adding a tablet called mifepristone, which is already used for other pregnancy-related conditions, could make the methotrexate treatment more effective. The goal is to reduce the number of women who need emergency surgery and speed up recovery. This large study will involve women from UK hospitals who are suitable for medical treatment for ectopic pregnancy, comparing the new combination with methotrexate alone.
At a glance
What is this study about?
When a pregnancy starts to grow outside of the womb, usually in a fallopian tube, it's called an ectopic pregnancy. These pregnancies can't develop properly and can become very serious, sometimes leading to life-threatening bleeding if the tube bursts. It's a condition that affects many women and is a leading cause of health problems in early pregnancy. Thankfully, if caught early, about 4 in 10 women can be treated with a medication called methotrexate, which avoids the need for surgery.
However, methotrexate isn't always a perfect solution. It can take several weeks to work, may require many hospital visits, and sometimes doesn't work at all, meaning about a third of women still end up needing surgery. Because of these challenges, doctors are looking for better ways to treat ectopic pregnancies without surgery. This is where a drug called mifepristone comes in.
Mifepristone is a tablet that's already used for other pregnancy-related treatments. Doctors believe it might help methotrexate work better by affecting a key pregnancy hormone. While some early research suggests this could be true, it hasn't been properly tested in a large, well-designed study yet. This study aims to fill that gap. We want to find out if adding a single dose of mifepristone to the standard methotrexate treatment helps women avoid surgery and recover faster compared to receiving methotrexate with a dummy tablet (a placebo). The information gathered from this study could significantly improve care for women with ectopic pregnancies in the future.
Key takeaways
- Study aims to improve non-surgical treatment for ectopic pregnancy.
- Investigates if adding mifepristone to methotrexate reduces need for surgery.
- Involves women already suitable for methotrexate treatment.
- Participation includes taking an extra tablet and routine blood tests.
- Potential to improve future care for women with ectopic pregnancy.
- Study runs from late 2025 until mid-2028 across UK hospitals.
Who may be eligible?
This study is looking for women who are at least 16 years old and have been diagnosed with an ectopic pregnancy in their fallopian tube. This diagnosis will be confirmed by ultrasound scans, which will show where the pregnancy is located and that it's not developing normally.
You would be considered for the study if your doctors have already decided that the standard methotrexate injection is a suitable treatment for you, and you have chosen to go ahead with it. Also, your hormone levels before treatment should be within a specific range, and you should be generally stable and able to attend follow-up appointments.
Essentially, the study is for women who are already candidates for methotrexate treatment for an ectopic pregnancy and who are in a stable condition.
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.
- Am I at least 16 years old?
- Has my doctor told me I have an ectopic pregnancy in my fallopian tube?
- Has my doctor said that methotrexate injection is a suitable treatment for me?
- Are my hormone levels (hCG) within the range of 1000 to 5000 IU/L?
- Can I attend regular follow-up appointments at the hospital?
- Am I generally stable and well enough for medical treatment?
What does participation involve?
If you decide to take part in this study, you'll be one of 328 women from about 40 hospitals across the UK. You'll have an equal chance of receiving either the mifepristone tablet or a dummy tablet (placebo) at the same time as your first methotrexate injection. Neither you nor your doctor will know which tablet you've received, to ensure the results are as fair as possible.
To help us understand how the treatments work, we'll collect blood samples. These samples will be taken before your treatment starts and then on days 1, 4, 7, and 11 after your methotrexate injection. These blood tests are mostly what you would have as part of your usual care for ectopic pregnancy. We'll be looking at how specific hormone levels change over time. We'll also compare things like whether you needed emergency surgery, how long it took for your hormone levels to return to normal, how many hospital visits you needed, and if you required a second methotrexate injection. The study is expected to run from October 2025 to July 2028.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is an ectopic pregnancy?
It's when a pregnancy grows outside the womb, usually in a fallopian tube. It can't develop normally and needs treatment.
What is methotrexate?
It's an injection used to treat ectopic pregnancy without surgery by stopping the pregnancy from growing further.
What is mifepristone and how is it taken?
It's a tablet, used in other pregnancy-related treatments, that might help methotrexate work better. It's taken once by mouth.
Will I know if I'm getting the active drug or a dummy pill?
No, to make the study fair, neither you nor your doctor will know if you're getting mifepristone or a dummy pill.
Who is paying for this study?
The study is funded by the National Institute of Health and Care Research, which is the research part of the NHS.
How to find out more
Claire Cochran
Always speak to your GP or specialist before deciding to take part in a study.
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