Ectopic pregnancy (EP) affects 1 in 90 pregnancies. EP is the leading cause of death for women in the first 3 months of pregnancy. It occurs when a pregnancy grows in an abnormal location outside the womb, usually within a Fallopian tube. Historically, the only treatment was an operation to remove the affected Fallopian tube together with the EP inside. Nowadays around 40% of women can be diagnosed early (before signs of 'rupture'), and the EP can be treated medically with an injection, called methotrexate (MTX), which avoids a hospital stay.

In women where active treatment is recommended, MTX is suboptimal. One in seven (1 in 7) women will need a second injection and just under a third will ultimately need surgery to treat the EP.

What is the study about?
We know that some ectopic pregnancies can be treated using a medication called methotrexate which is given by injection. This is the drug your clinical team have offered you to treat the ectopic pregnancy.

We also know that up to 30% of women who have methotrexate may still need emergency surgery to treat their ectopic pregnancy. We are testing to see if adding a different drug to the usual medical treatment for ectopic pregnancy (the injection of methotrexate) could reduce the need for surgery in women with ectopic pregnancies.

This new drug is called mifepristone. It works against a key pregnancy hormone called progesterone, so we think adding this medication might further reduce the risk of needing surgery for women who opt for medical management of their ectopic pregnancy by helping to treat the ectopic pregnancy in a different way to methotrexate. We also think it might shorten the follow up time for the pregnancy hormones to reduce and reduce the number of women who need a second injection. Mifepristone is used for other types of pregnancy loss and so we think it might have a role in treating an ectopic pregnancy.

Why do we need to do this study?
At the moment we do not know if mifepristone added with methotrexate works better to treat ectopic pregnancy than methotrexate alone. So this study will answer this question. To test if adding this drug (mifepristone) works we are carrying out this study by asking people to take part who have already had a diagnosis of ectopic pregnancy confirmed by ultrasound scan, who have been offered and accepted treatment with methotrexate and where your clinical team have confirmed it is safe for you to have treatment with medication.

What will the study involve?
Everyone in the study will receive methotrexate as planned by your clinical team. By taking part in the study, we will ask half of participants to have the study drug (called Mifepristone) and half of participants will receive a dummy drug (a placebo) which looks identical to the study drug. You nor the team looking after you will know which one you received if you take part as this is really important for us to test whether or not the drug makes a difference or not without any risk of bias.

We know most ectopic pregnancies are located in a Fallopian tube so we are testing this new treatment in women who have had an ectopic pregnancy seen on ultrasound scan which is thought to be in the Fallopian tube.

What will taking the mifepristone or placebo involve?
Both mifepristone and the placebo will be taken once as 3 tablets. This will be taken on the same day as your injection of methotrexate. It is a single dose and will not be repeated again during the study, even if you have a second injection of the methotrexate. You will only take the 3 tablets once. If you take part, you will be randomly allocated to either having the mifepristone or the placebo tablet. This is the fairest way to test a medication.

What follow up will be needed?
As part of the usual methotrexate treatment, you will need to have blood tests at different intervals to make sure the treatment is working and until the pregnancy hormone (hCG) reduces to a non-pregnant level. If you take part in the study we will ask for the team to send an additional test for the study to look at the levels of the hormone progesterone in your blood and track how they respond to treatment too. We don’t know how progesterone levels respond to methotrexate or mifepristone so this will provide new information.

For the study there will be no additional blood tests as the progesterone levels can be tested at the same time as your routine blood tests for hCG in the same test tube.