Core Outcome Sets for Mental health following Early Pregnancy loss (COSMEP)

Early pregnancy loss can be devastating for both women and their partners. Up to 1 in 3 women will suffer significant psychopathology triggered by an early pregnancy loss. Given that 1 in 100 pregnancies are ectopic and 1 in 5 result in miscarriage, large numbers of women are at risk of significant psychological morbidity. Research establishing the burden of psychopathology and interventions to improve mental health following an early pregnancy loss use a variety of tools to measure different psychopathological outcome. The heterogeneity in measures and outcomes makes it challenging to collate and compare evidence when looking at a group of studies. In turn, this reduces the opportunity to draw strong evidence based conclusions that could improve care for women and their partners. In addition, key outcomes may also be going unmeasured, particularly those that are most important to patients and their partners. We aim to develop a core outcome set for mental health following early pregnancy loss in order to focus future research on outcomes deemed the most important by key stakeholders.


• To systematically review and collate outcomes already in use for measuring the psychological impact of and interventions to improve mental health following early pregnancy loss.
• To establish which mental health outcomes following early pregnancy loss matter most to women and their partners using qualitative methods.
• To establish a core outcome set agreed on by key stakeholders that can be applied to future research into mental health following early pregnancy loss.
• To disseminate a core outcome set for mental health following early pregnancy loss.


Principal Investigator:
Professor Tom Bourne, Imperial College London

Professor Arri Coomarasamy, University of Birmingham,
Dr James Duffy, Institute for Women's Health, University College London, London, UK.

Research Fellow:
Dr Nina Parker, Imperial College London

Further Study Information

Current Stage: Planning
Date: February 2021 - February 2023
Funding source(s):

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Psychopathology following early pregnancy loss

Target Population

Age Range: 16 - 50

Sex: Female

Nature of Intervention: Psychological & behavioural

Stakeholders Involved

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

Study Type

- COS for clinical trials or clinical research
- COS for practice


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

A systematic review of the literature in combination with focus groups or interviews will identify potential core outcomes. Within the methodology to develop a core outcome set for mental health following early pregnancy loss, key stakeholders such as patients, partners, charities, researchers and clinicians will be engaged. A Delphi survey followed by a consensus meeting will refine the list of outcomes to be included in the core outcome set. The results will be disseminated by publication in a peer-reviewed journal.

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