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 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

One of the key things that we believe at the Ectopic Pregnancy Trust is the importance of treatment choice.  When someone is, sadly, diagnosed with an ectopic pregnancy, we believe that there should be as many options as possible available for treatment and that a woman should have a right to choose which method she thinks will be most suitable for her.

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.

GEM3 Trials

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

NHS Fife

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.

Complete the Questionnaire

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