COSMisT
Research type
Research Study
Full title
Core Outcome Sets for MIScarriage Trials (COSMisT)
IRAS ID
196321
Contact name
Paul Smith
Contact email
Sponsor organisation
The University of Birmingham
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Miscarriage is the failure of pregnancy before 23 weeks. It is common in early pregnancy occurring in around one in five pregnancies and it has been estimated that around 15% of women will suffer from a miscarriage during the reproductive life span. Miscarriage can have a negative effect on both the physical and mental health of the woman and her partner. Miscarriage has the potential to cause physical harm to patients including: infection, severe bleeding, perforation of the womb and even death. Miscarriage also has a psychological impact on patients with research showing that the bereavement associated with miscarriage can be equivalent to those women suffering from a stillbirth at term.
There continues to be a great deal of research looking at ways to prevent miscarriage and optimise its management to reduce its associated psychological morbidity and complications. Often, however, studies do not address the same outcomes, making it difficult to draw conclusions when a group of studies is looked at as a whole. Research has also been lacking in establishing the most important outcomes for women and their partners. Increasingly, it is being realised that what is needed is an agreed standardised collection of outcomes (a ‘core outcomes set’) for all trials in a specific area. Miscarriage is an important research subject and deserves a core outcome set decided upon by all key stakeholders such as researchers, patients, clinicians and support groups. The aim of this study will be to develop core outcome measures for trials in the prevention and management of miscarriage.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0277
Date of REC Opinion
25 Jul 2016
REC opinion
Further Information Favourable Opinion