CompletedPhase IIIInterventional

A study to assess the safety of using 100 mg methotrexate for the treatment of an unruptured ectopic pregnancy

This study looks into using a standard 100mg dose of methotrexate for women with a stable ectopic pregnancy – that's when a pregnancy grows outside the womb, usually in a fallopian tube. Currently, the dose of methotrexate is individually calculated, which can lead to longer waiting times. Researchers want to see if giving a set 100mg dose to all eligible women is safe and works just as well. They will compare side effects with those from previous studies where lower, calculated doses were used. The goal is to simplify treatment and reduce stress for patients, without compromising safety, by providing a quicker and more consistent approach to care.

At a glance

Status

Completed

Phase

Phase III

Sponsor

Accord (United Kingdom)

Enrolment target

Start

26 Jul 2021

Estimated completion

31 May 2023

Ectopic pregnancy

What is this study about?

Imagine a pregnancy that starts to grow in the wrong place, usually in one of the tubes leading from your ovary to your womb. This is called an ectopic pregnancy. If it's caught early and is stable (meaning you're not in immediate danger), doctors often suggest a medicine called methotrexate. This medicine helps the pregnancy tissue go away naturally, often avoiding the need for surgery.

Right now, the amount of methotrexate you receive is carefully worked out based on your height and weight. While this ensures you get the right amount for your body, it can take time to calculate and prepare each dose, leading to delays and extra stress. This study is exploring a new idea: what if all suitable women with a stable ectopic pregnancy could just receive a standard 100mg dose of methotrexate? The hope is that this standard dose would be safe and effective for everyone, making the treatment process much quicker and simpler.

The main goal of this study is to check if this standard 100mg dose is safe. The researchers will carefully monitor women who receive this dose for any side effects and compare them to what's been seen in the past with individually calculated, often slightly lower, doses. They want to make sure that a standard dose is just as safe and helps resolve the ectopic pregnancy effectively.

Key takeaways

This study explores a standard 100mg dose of methotrexate for ectopic pregnancy.
It aims to simplify and speed up treatment compared to individual dose calculations.
The focus is on checking the safety of this standard dose.
Participation involves receiving the 100mg dose and standard follow-up care.
It's for women aged 18-45 with a stable ectopic pregnancy.
The study is taking place at the Royal Infirmary of Edinburgh.

Who may be eligible?

This study is looking for women aged between 18 and 45 years who have been diagnosed with a stable ectopic pregnancy. To join, your doctors must have decided that methotrexate is the right treatment for you. Your blood tests, especially for your pregnancy hormones (hCG), and your general health, like your blood count and how well your kidneys and liver are working, will also be checked to make sure it's safe for you to take part.

There are also some specific measurements for your body size and the ectopic pregnancy itself that you would need to meet. For example, the ectopic pregnancy shouldn't be too large on the scan, and there shouldn't be signs of significant bleeding inside your tummy.

You wouldn't be able to join if you're experiencing severe tummy pain, or if scans show a healthy pregnancy inside your womb. Also, if you're breastfeeding or your blood tests show significant problems with your blood, kidneys, or liver, you wouldn't be able to take part.

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 aged between 18 and 45?
Have you been diagnosed with a stable ectopic pregnancy?
Has your doctor already decided that methotrexate is suitable for your treatment?
Are you feeling well and not experiencing significant tummy pain?
Are you not currently breastfeeding or are willing to stop?
Are your blood tests and scans within normal limits for this treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a single, one-off dose of 100mg of methotrexate. This would be given to you at the Pregnancy Support Centre within the Royal Infirmary of Edinburgh. All the women in this study would normally have received a slightly lower, specially calculated dose of methotrexate if they weren't in the study.

After you've received the medicine, there are no extra appointments required for the study. You would continue to have the same follow-up appointments and blood tests that you would normally have with your healthcare team until your ectopic pregnancy has completely resolved. During these follow-up appointments, doctors will be noting down any side effects you experience as part of the study.

Potential risks and benefits

This study is looking to see if a standard dose of methotrexate is safe and straightforward for treating ectopic pregnancies. A potential benefit could be a quicker, simpler treatment process, as less time might be spent calculating and preparing individual doses. The main risk involved is whether the 100mg dose might lead to different or more side effects compared to a smaller, individually calculated dose, which is what the study aims to explore by comparing with past information. You have the right to withdraw from the study at any time without any impact on your medical care.

Locations (1)

NHS Lothian
Approximate
Edinburgh, Scotland

Common questions

What is an ectopic pregnancy?

An ectopic pregnancy happens when a fertilised egg grows outside the womb, usually in a fallopian tube. It can't develop normally there.

What is methotrexate?

Methotrexate is a medicine often used to treat stable ectopic pregnancies. It helps the pregnancy cells stop growing and dissolve naturally, often avoiding the need for surgery.

Why is this study giving a standard dose? Doesn't everyone need a different amount?

Normally, the dose is calculated individually. This study is testing if a standard 100mg dose is safe and effective for everyone, aiming to make treatment quicker and simpler by avoiding individual calculations.

Will I have extra hospital visits if I join this study?

No, you won't have any extra visits. Your follow-up care will be exactly the same as for women not in the study, until your ectopic pregnancy is resolved.

Who is paying for this research?

The study is funded by the Nordic Pharma Group.

How to find out more

Ann Doust

ann.doust@ed.ac.uk +44 (0)7810643488 Official trial record

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