What the trial is about
Funded by a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership, the research team will investigate whether a drug called mifepristone is more effective at treating ectopic pregnancy than the current medical treatment.
The research team hope this trial will demonstrate that treatment with mifepristone alongside the existing drug treatment, methotrexate, will reduce the need for emergency surgery for many women. Mifepristone which works by blocking progesterone, a key hormone of pregnancy.
This trail will be referred to as the AMETHYST Trial: Adding Mifepristone to mETHotrexate for ectopic pregnancY STudy.
Why this trial is important
Around 1 in 80 pregnancies are ectopic, which means the embryo starts to grow in an unexpected place, often outside the uterus and usually in one of the Fallopian tubes. As it grows, there is a risk that the Fallopian tube can burst which can lead to life-threatening internal bleeding. When this happens, emergency surgery to remove the affected Fallopian tube is usually necessary and can be lifesaving.
More recently, improved diagnosis of ectopic pregnancy has meant that some women can be treated with medication which reduces the need for surgery. However, with current medical treatment, up to 30 percent of women will still require emergency surgery and removal of their Fallopian tube.
Helen, 43, from Cardiff, is Project Co-ordinator at The Ectopic Pregnancy Trust. Helen experienced two ectopic pregnancies before having twins four years ago using IVF:
“The first ectopic pregnancy I had ended up with a ruptured Fallopian tube so I had to have surgery where I lost the tube. This was extremely hard for me – I felt like I had to learn to walk and live again all in one go, whilst trying to heal both physically and mentally.
“It took a good few years of healing before I felt ok again. I had never had any surgery previously, let alone any major unexpected surgery, so this was difficult to process both physically and mentally for some time.
“With my second ectopic pregnancy, I lost my remaining Fallopian tube. Whilst this was an ‘easier’ surgery, I found this more mentally challenging than the first as I was also going through some major life changes at the same time.
“Having suffered two ectopic pregnancies, with the first being medically managed with methotrexate but unfortunately rupturing that same evening, I believe the new drug trial offers a valuable opportunity to support those experiencing ectopic pregnancies and potentially help them avoid surgery.”
Who is conducting this trial?
The trial will be led by Dr Andrea Woolner, Senior Clinical Lecturer at the University of Aberdeen, along with a team of experts from the Universities of Edinburgh, Nottingham and Birmingham, University College London, Monash University, Australia, Imperial College London and The Ectopic Pregnancy Trust.
Dr Andrea Woolner, chief investigator on the trial said: “Ectopic pregnancy is a devastating pregnancy loss which has significant physical and psychological impacts on women and their families, and the medical management of ectopic pregnancy has essentially had no advances in over 20 years.
“This is a really exciting opportunity to trial an additional drug alongside standard treatment for medical management of ectopic pregnancy. During the course of this trial, we plan to recruit women who are eligible for medical treatment of ectopic pregnancy across 40 early pregnancy units in the UK.
“We strongly believe that the addition of mifepristone to standard treatment could reduce the need for emergency surgery.”
Munira Oza, Chief Executive of The Ectopic Pregnancy Trust, a UK wide charity dedicated to ectopic pregnancy, commented: “With emergency surgery often being required in ectopic pregnancy, the loss of control that a woman feels through the physical trauma, the lack of treatment choice, or potential failure of treatment, can contribute to considerable psychological impacts.
“Working with hundreds of women each year, we regularly hear about these intense physical and emotional effects of ectopic pregnancy.
“There is very much a need to consider and investigate alternative treatments. Earlier diagnosis, ongoing research, and the hope of more treatment options can help to expand patient choice and reduce some of the physical and emotional burden of ectopic pregnancy.
“We wholeheartedly welcome this trial.”
Baroness Merron, Parliamentary Under-Secretary of State at the Department of Health and Social Care, added: “Around one in 80 pregnancies are ectopic, which can be life-threatening. This new trial could be a game-changer in helping hundreds of women avoid emergency surgery each year.
“I look forward to seeing the results of this important research which could play a big part in reducing the physical and psychological trauma suffered by so many women during ectopic pregnancies.
“This government is prioritising women’s health as we reform the NHS.”
How The EPT supports research
Through the support we provide, we hear first-hand accounts from people who experience ectopic pregnancy and their partners who share their lived-experiences. In this way, we are equipped to be able to provide the patients’ voice to inform help inform research. You can read more about the research we have been involved in on our website.
Supporting you
We understand that reading about new treatment options for ectopic pregnancy may be difficult and bring up many complex emotions. If you require any support, please do get in touch with us.
