Welcome to the GEM3 Trial
Welcome to the GEM3 Trial
Trial title: A double blind placebo controlled trial of a combination of methotrexate and gefitinib versus methotrexate alone as a treatment for ectopic pregnancy
Our objective?
We aim to assess if a combination of methotrexate (MTX) and gefitinib reduces the need for surgical treatment of an ectopic pregnancy against MTX treatment alone.
Why we are doing this research?
Ectopic pregnancy (EP) is when an embryo grows in a Fallopian tube (although it can grow in other areas) and not in the womb. If this pregnancy continues to grow in the Fallopian tube there may be stretching and ultimately rupture of the tube causing life-threatening, internal bleeding. Fortunately most EPs are now diagnosed before they rupture. Management of these EPs depends on symptoms, pregnancy size, presence of internal bleeding and hCG measurement (pregnancy hormone). In women who present with an EP are in a stable condition (no internal bleeding, small pregnancy size) they can be treated with a drug called methotrexate. This means that these patients do not need an operation to remove the ectopic pregnancy which reduces the risks involved in surgery and they can preserve their Fallopian tube. In 30% of women, methotrexate is unsuccessful and they still need an operation. We want to see if we can reduce this number by using an additional tablet with the methotrexate injection to treat the EP. This drug is called gefitinib and is a known drug used at the moment to treat people with a specific type of lung cancer. This tablet is only taken for seven days. In order to test this combination properly we need to run a randomised controlled trial, which means half of the patients will get the gefitinib and half will get a dummy tablet (placebo) and no-one will know what tablet they get until the end of the trial. The women will be followed up as normal in their early pregnancy units with no extra visits needed. At the end of the trial we will then look and see how many participants needed surgery and how many were on gefitinib and how many were on placebo and this will tell us if the combination of drugs works better. This means we may potentially, in the future, have a better treatment for women, sadly having an ectopic pregnancy.
Who is doing this research?
The trial is being run by Professor Andrew Horne at the University of Edinburgh and is funded by the National Institute for Health Research (NIHR).
We are supported by the University of Edinburgh, University of Birmingham and NHS Lothian.
Co-investigators are Professor Stephen Tong (University of Melbourne), Professor Siladitya Bhattacharya (University of Aberdeen), Professor Colin Duncan (University of Edinburgh), Professor Arri Coomarasamy (University of Birmingham), Mrs Alexandra Peace Gadsby (Ectopic Pregnancy Trust), Professor Jane Daniels (University of Nottingham), Mr Lee Middleton (University of Birmingham), Professor Ben Mol (University of Adelaide), Mr Davor Jurkovic (University College London), Miss Cecillia Bottomley (Chelsea and Westminster Hospital) and Professor Tom Bourne (Imperial College London).
Trial Management Team
Mrs Ann Doust (Research Manager), Dr Magda Koscielniak (Trial Manager), Mr Jordan Doust (Trial Administrator), Mrs Nicola Watson (Specialist Research Nurse), Ms Priscilla Fernandez (Specialist Research Midwife).