A core outcome set for COVID-19 and emerging pathogens in pregnancy

Pregnant women may be more susceptible to severe disease and mortality than non-pregnant women of the same age. The pregnancy may potentially be at increased risk of pregnancy loss, congenital anomaly, preterm birth or other adverse outcomes. In addition, little is known about neonatal or longer term infant outcomes.

Pregnant women are frequently excluded from interventional clinical trials and therefore it is vital that were they are included both disease specific and pregnancy specific outcomes are consistently reported.

Contributors

Principle Investigator:
Clare Whitehead, Pregnancy Research Centre, Obstetrics and Gynaecology, University of Melbourne and Royal Women's Hospital, Parkville, Australia

Collaborators:
William Crozier, Pregnancy Research Centre, Obstetrics and Gynaecology, University of Melbourne and Royal Women's Hospital, Parkville, Australia

Further Study Information

Current Stage: Withdrawn
Date: August 2020 - August 2022
Funding source(s): Internal funding


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Coronavirus

Target Population

Age Range: 12 - 55

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Epidemiologists
- Families
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Semi structured discussion
- Survey
- Systematic review

We will perform a systematic review of published protocols for interventional studies of COVID-19 that include (or do not actively exclude) pregnant women. We will identify pregnancy specific outcomes for both the mother, fetus, infant and child.

We will conduct focus group interviews pregnant women who have had or are at risk of COVID-19 in pregnancy. We will survey international experts and stakeholders to identify other outcomes of relevance. These data will inform an international Delphi survey where stakeholders will rank proposed outcomes. Selected outcomes will be brought forward to a consensus meeting where core outcomes will be defined. We will then complete a second consensus process to define measures for each core outcome.

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