Core outcome set for studies of pregnancy affected by multimorbidity

Increasingly more pregnant women are living with pre-existing multimorbidity and this may affect maternal and offspring outcomes. Further research is required to understand this association and to develop interventions. However, there is currently no existing core outcome set (COS) for this area of research.

We propose a four stage study design: 1) systematic literature search, 2) focus groups, 3) Delphi surveys, and 4) consensus group meeting.

First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted amongst 1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners), and 2) their health/social care professionals to identify outcomes important to them.

Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include 1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, 2) health/social care professionals involved in their care, and 3) researchers in this field.


MuM-PreDiCT Collaborators from the following institution: University of Birmingham, University of Aberdeen, Queen's University of Belfast, University of St Andrews, Guy’s and St. Thomas’ NHS Foundation Trust, The University of Manchester, Swansea University, Keele University, women representatives



Journal: BMC medicine
Volume: 21
Pages: -
Year: 2023
DOI: 10.1186/s12916-023-03013-3

Further Study Information

Current Stage: Completed
Date: June 2021 - August 2022
Funding source(s): Applying for Medical Research Council funding as part of the MuM-PreDiCT project

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Multimorbidity

Target Population

Age Range: 15 - 49

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Service users

Study Type

- COS for clinical trials or clinical research


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