Improving Miscarriage Prevention Research – survey of stakeholders
Research type
Research Study
Full title
Improving Miscarriage Prevention Research – a survey exploring the Expectations of Service users and Stakeholders (IMPRESS)
IRAS ID
314809
Contact name
Joshua Odendaal
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Miscarriage is the loss of a pregnancy before it reaches a viable age. Sadly, around 10% of the population experience at least one miscarriage and many lead to significant physical and psychological consequences.
Some miscarriages can be prevented with investigation and targeted treatment, but many miscarriages are currently unexplained and therefore there is no preventative treatment available. New treatments to prevent miscarriage should be tested in a clinical trial, often by comparing the new treatment to standard care to determine if it is more effective. The threshold for what is considered an effective treatment is set by the researchers.
Often these trials need large numbers of women to find out if the treatment is working. However, it may be that during the trial, researchers can review the results at intervals and decide whether it is worth continuing the trial. Either, because there is enough evidence that the treatment is successful or enough evidence that it is futile. This would be advantageous as researchers would not need to recruit as many patients to a trial and could come to a decision about treatment efficacy earlier.
Currently there are no recommended criteria or clinical literature to inform on the statistical thresholds for stopping or continuing a miscarriage prevention trial. The aim of this research is to understand, through administration of an online survey, patient and health care professional views on what they consider a meaningful treatment difference and stopping criteria for a trial to prevent miscarriage.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
23/NW/0322
Date of REC Opinion
30 Jan 2024
REC opinion
Further Information Favourable Opinion