The RESPONSE trial
The RESPONSE trial tested a new medication, called NT100, in women with unexplained repeated miscarriages. They wanted to find out if it improves the chances of maintaining a successful pregnancy, if there are any side effects of the medicine and if it is easy to use.
N.B. At February 2018, the results of the trial have not yet been published.
In the meantime, though, if you took part in the trial and you want to find out whether you were on the active treatment or a placebo, you can.
You just need to contact your research team (by email or letter might be best, so there’s a record) and tell them that you want to know whether you had the treatment or placebo when you were in the trial. They will complete and submit a form on your behalf. It might take a bit of time, but you will get the information.
If the research team has changed and your main contact isn’t there any more, there will still be someone in the Trust’s Research & Development (R&D) department who can take this on.
NT100 is a man-made form of a protein called G-CSF (granulocyte colony-stimulating factor). G-CSF is a naturally occurring protein in the female reproductive tract.
RESPONSE was a randomised, double-blind, placebo-controlled trial:
Randomised: The women who took part were given either the treatment medicine (NT100) or a placebo – a dummy drug that has no active ingredients. A computer made the selection so it was completely random.
Double-blind The women in the trial weren’t told whether they were taking the active medicine (NT100) or the placebo – and neither were their doctors. So both were “blinded” to this information.
Placebo-controlled Half of the women in the study had the active medicine and half the placebo (they are called the control group). The medication that they received looked exactly the same to them and their doctors, but a completely separate study group has kept a record of which women had NT100 and which had the placebo.
Information given to women who were interested in taking part in the RESPONSE trial
Who can take part
You may be eligible for the RESPONSE trial if you:
- are between 18 and 37 years old
- have had three or more unexplained miscarriages:
- it doesn’t matter if they were consecutive (one after the other) or not
- want to try for another pregnancy.
What the trial involves
Women taking part in the trial will need to use ovulation tests and urine pregnancy tests while trying to conceive. These will be given to you by the research study team.
Once you are pregnant, you will need to make up to 12 clinic visits during your pregnancy. You will be able to claim back reasonable travel expenses, such as public transport or parking costs.
Which hospitals are taking part
The following hospitals are recruiting patients:
- Ashington, Northumberland Wansbeck Hospital
- Birmingham City Hospital
- Birmingham Heartlands Hospital
- Birmingham Women’s NHS Foundation Trust
- Chertsey Ashford & St Peter’s Hospital
- Coventry & Warwickshire University Hospitals
- Edinburgh Edinburgh Royal Infirmary
- Frimley, Surrey FrimleyPark Hospital
- Leeds St James’s University Hospital
- Liverpool Women’s Hospital
- London Guys Hospital
- London St Mary’s Hospital
- Manchester St Mary’s Hospital
- Middlesborough James Cook University Hospital
- Newcastle Royal Victoria Infirmary
- Nottingham Nottingham University Hospitals
- Oxford John Radcliffe Hospital
- Plymouth Derriford Hospital
- Southampton Princess Ann Hospital
- South Shields South Tyneside District Hospital
- Sunderland Royal Hospital
- Wirral Arrowe Park Hospital
If you have any questions about the trial, do contact us at email@example.com or call us on 01924 200799.