Research into the effects of ectopic pregnancy by Monash University
What is the research about? Monash University is conducting research in ectopic pregnancy with the “aim of standardising core outcomes in published papers.”
To explain this, we first need to think about how, in choosing between different treatments, patients, healthcare professionals, and others need evidence about what works. This evidence is obtained by carrying out studies to measure the effects that different illnesses, conditions, and treatments have on patients. These effects are often called ‘outcomes’ and cover a wide range like quality of life, side-effects, days off work, fatigue, pain etc. This research aims to finalise a set of core outcomes (or “effects”) that could help guide future clinical guidelines and studies on ectopic pregnancy.
How can I help? Monash University would like to hear from women who have experienced an ectopic pregnancy, based anywhere in the world. It is important for women who have experienced the many effects of an ectopic pregnancy and treatment to be involved in improving care and your contribution will be valuable to any future research into ectopic pregnancy.
What will the research process involve? You will be invited to participate in surveys in which you will be asked to rank outcomes/effects in order of importance. You will also be invited to suggest additional outcomes. Any additional outcomes will need to be considered by the steering group (experts who are overseeing the research) and potentially included for review in round two. In round two, you will be asked to reflect upon any similarities or differences between groups and then score each outcome again, as well as any additional outcomes suggested in round one using the Likert scale (positive/negative responses to a statement). A final consensus round will review the results and aim to develop a final core outcome for ectopic pregnancy. If necessary, the steering group may suggest the need for a further Delphi study round.
How do I sign up? If you would like to participate, please contact the research team at Monash University firstname.lastname@example.org by the end of November. You will be invited to provide your details and be provided with a unique identifier for anonymity.
What if I change my mind? Participation in this research project is voluntary. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. If you decide to withdraw from the project, please notify a member of the research team in advance.
Need to know: There are no costs associated with participating in this study, nor will you be paid. No personal information will be used in this research. This project has been approved by Monash Health Human Research Ethics Committee.
Support: We at the EPT understand that an ectopic pregnancy is an overwhelming experience and participating in this research may cause a mix of emotions to resurface. The EPT’s support services are available should you need someone to lean on.
Research into methotrexate treatment for ectopic pregnancy
Methotrexate is one such form of treatment where the medicine is injected into the muscle and works to remove folate from the body to stop the ectopic pregnancy cells from dividing. This method of treatment, as opposed to surgery where the tube is typically removed, preserves the Fallopian tube and enables a faster physical recovery time. The downside of methotrexate is it can have temporary side effects where the lady feels very ill. Methotrexate sometimes requires a second injection and is successful in 66-95% of cases depending upon the study.
A group of researchers, led by Professor Andrew Horne of the University of Edinburgh, are running the GEM3 trial which is a multi-centre, double-blind, placebo-controlled randomised trial. This trial is seeking to establish whether medical treatment of ectopic pregnancy with the drug methotrexate is more effective when used in combination with the drug gefitinib. The study will be available at up to 50 centres across the UK.
Eligible patients will be offered the opportunity to be randomised to either the gefitinib or the placebo to be used in combination with the methotrexate. This involves taking one tablet a day for 7 days starting from the day the methotrexate is given, which is usually a single injection. Sites are now starting to open across the UK.
Currently open are:
Chelsea and Westminster Hospital NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Dartford and Gravesham NHS Trust
North Cumbria University Hospitals NHS Trust
Nottingham University Hospitals NHS Trust
Guy’s and St Thomas’s NHS Foundation Trust
Hampshire Hospitals NHS Trust
Hinchingbrooke Health Care NHS Trust
University Hospitals of North Midlands NHS Trust
Liverpool Women’s NHS Foundation Trust
Surrey and Sussex Healthcare Trust
Northumbria Healthcare NHS Trust
Frimley Health NHS Foundation Trust
Warrington and Halton Hospitals NHS Foundation Trust
University Hospitals Coventry and Warwickshire NHS Trust
Plymouth Hospitals NHS Trust
Royal Wolverhampton NHS Trust
The Princess Alexandra Hospital in Harlow
Cambridge University NHS Foundation Trust
NHS Forth Valley
Buckinghamshire Hospitals NHS Trust
Bedford Hospital NHS Trust
Central Manchester University Hospitals NHS Foundation trust
Heart Of England NHS Foundation Trust
Countess of Chester Hospital NHS Foundation Trust
Norwich and Norfolk University Hospitals NHS Foundation Trust
Borders General Hospital in Melrose
South Tyneside District Hospital
The Royal Infirmary of Edinburgh
Aberdeen Royal Infirmary
Ninewells Hospital, Dundee
Glasgow Royal Infirmary
Crosshouse Hospital, Kilmarnock
East Lancashire Hospitals NHS Trust
West Suffolk NHS Foundation Trust
Chesterfield Royal Hospital NHS Foundation Trust
South Tees NHS Foundation Trust
Walsall Healthcare NHS Trust
Research into experiences of ectopic pregnancy
If you have been affected by ectopic pregnancy, you are invited to complete our Research Questionnaire. The responses help us to talk to the media, the healthcare professionals, and the general public about the experience of those who adjust to a life after ectopic pregnancy. Your contributions are used to guide these powerful agencies, in delivering care and information on the condition to a wider audience.