Core outcome measures for prevention of miscarriage trials

Miscarriage is the commonest complication of pregnancy and occurs in one in five pregnancies. Miscarriage has the potential to cause physical harm to patients including: infection, severe bleeding, perforation of the uterus 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 is a great deal of research looking at ways to prevent miscarriage and 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. The aim of this study will be to develop core outcome measures for trials in the prevention of miscarriage.

Link to protocol: http://bmjopen.bmj.com/content/7/11/e018535

Contributors

Principle Investigator: Dr Paul Smith, The University of Birmingham
Supervisor: Arri Coomarasamy, The University of Birmingham
Collaborators: Khalid Khan, Queen Mary University of London

Further Study Information

Current Stage: Ongoing
Date: October 2015 - October 2017
Funding source(s): NIHR post doctoral fellowship


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Miscarriage

Target Population

Age Range: 16 - 60

Sex: Female

Nature of Intervention: Drug, Surgery

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review

To develop the core outcome set the methodology will engage all key stakeholders (clinicians, researchers, patients, partners, charities). Systematic reviews of the literature combined with interviews and focus groups with stakeholders will be conducted to identify a list of potential core outcomes. A Delphi survey will then be used to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions.

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