Research and Innovation
Summer 2018
The GEM 3 study is looking at whether lung cancer drug gefitinib taken alongside methotrexate can stop an ectopic pregnancy developing without the need for surgery or further medication. An ectopic pregnancy is when a fertilised egg implants itself outside of the womb, usually in one of the fallopian tubes. There is no chance of this pregnancy surviving and it can be life threatening if left untreated. If picked up early, a single dose of methotrexate is given. However, if this does not terminate the pregnancy within two weeks, another dose or surgery may be needed. Women being treated with methotrexate are invited to take part in the study and are given either gefitinib or a placebo (dummy drug) to take as well. Neither researchers nor participants are told which they are getting, so they can be compared without bias One of our patients, Lorraine, was admitted to Stoke Mandeville hospital for sepsis (blood poisoning) and was given a blood test which revealed an ectopic pregnancy. The mother-of-two said: “I was in a lot of pain, but because I had sepsis at the time I couldn’t pinpoint whether it was that or the ectopic pregnancy. Had I just been dealing with the ectopic pregnancy, my symptoms may have been different.” After her sepsis was treated with antibiotics, Lorraine was discharged to the hospital’s maternity ward. She said: “The research midwives approached me and told me I could either take part in a new drug trial or have surgery. The new drug sounded like it would get everything over with quicker in the least invasive way possible, so I thought it was a great idea. I’m quite a helper. If something good can come out of something bad and help more people, it’s a great thing to do. I am also quite a curious person and I thought if the trial drug would make my life a bit easier, then why not?”
The research team, happy at work in the maternity unit
Lorraine urges others to consider taking part in research after figures showed 4,024 participants took part in 79 studies supported by the National Institute for Health Research (NIHR) at Buckinghamshire Healthcare NHS Trust. Lorraine said: “I would definitely recommend investigating research and finding out more, even if you don’t decide to go on a trial. I would consider taking part again.” Lorraine, who was eight weeks pregnant at the time of her diagnosis, said: “I hadn’t had a lot of emotional attachment to the pregnancy as I didn’t know about it before I found out it wasn’t viable. It was a bit different from having a miscarriage. This was more of a medical issue than an emotional one.” She said: “I feel very lucky, fortunate and humbled my diagnosis and treatment happened when they did and that I’m okay.”
For more information on obstetric and gynaecology studies contact the research midwife team on 01296 418160.
Where can I find out about study results? To promote transparency in research, studies are bound by the approval processes during set up to publish their results (good or bad) and share the information with peers and participants at the end. This can be via presentation to conference, publication in scientific journals and is sometimes summarized in newsletters to participants. It is considered good practice to communicate results and proposed changes in care to participants and other interested groups. The participant information sheet should include how results will be published. A good source of study results is the NIHR Dissemination Twitter feed @NIHR_DC. Clinical trials of a medicinal product are required to publish results within one year on a European database called EuDRACT. For further information about research opportunities at Bucks Healthcare NHS Trust please contact the Research and Innovation Department at Stoke Mandeville hospital on 01296 316065 or see the website at www.buckshealthcare.nhs.uk/research You can also follow us on facebook or Twitter @BHTResearch