Essential outcomes to be reported in all obstetric studies

Obstetrics involves two intricately-related individuals - mother and baby. It is therefore not surprising that obstetric studies are likely to require a relatively larger number of outcomes (e.g. 28 for induction of labour and 48 for epilepsy). Core outcome sets developed for pregnancy-related conditions have identified that there are a number of maternal and fetal outcomes that are common to all studies related to pregnancy-related research. These outcomes are related to maternal and fetal/neonatal mortality and severe morbidity, among others. The burden of gathering these and some other important outcomes (birthweight, mode of childbirth) is small, given that they feature on birth certificates and discharge summaries, and are well represented by large datasets. Achieving consensus on a core set of outcomes to be reported in all pregnancy-related studies, would enable individual core-outcome sets to focus on core outcomes directly related to their scope.

Contributors

Outcome Reporting in Obstetric Studies (OROS) Investigators - PI: Rohan D'Souza

Further Study Information

Current Stage: Completed – pending publication
Date: January 2021 - December 2021
Funding source(s): None


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: N/A

Target Population

Age Range: 16 - 60

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Families
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers

Study Type

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

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review

We have conducted a literature review of all systematic reviews, interviews, Delphi methods and final core-outcome sets related to pregnancy-related conditions, which will enable us to identify outcomes that have been reported in all studies. We will follow this on with interviews with those that are/ have been pregnant, their family members and stakeholders involved in their care. This will be followed by a Delphi survey to arrive at consensus on what outcomes should be considered universal, and if possible, how they should be defined. At this point we refrain from stating what the consensus criteria will be. This will be determined by a study group which will involve representation of patients and other stakeholders.

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