The CO-OPT Study: Core Outcomes in First- and Second-degree Perineal Tears Prevention and Treatment

Background: Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, however, there is significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. This study is to present a protocol for a study to develop a core outcome set (COS) for studies investigating interventions for the prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears.

Methods: The development of this COS will be guided by an advisory group composed of clinicians, senior midwives. senior nurses, patients, and methodologists. This study will include a systematic review of the literature to identify outcomes that have been reported in prior studies in this area. A semi-structured interview with clinicians, nurses, and pregnant women will be conducted to collect their opinions on important outcomes. Key stakeholders shall then prioritize these outcomes using a Delphi study. A face-to-face consensus meeting shall be held with stakeholders to determine the list of outcomes included in the final COS.

Results: We will develop a COS that should be reported in future clinical trials to evaluate the effectiveness of first- and second-degree perineal tears prevention and treatment.

Discussion: The expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery.

Contributors

Lin Xiao, Nursing and Midwifery Evidence-based Center, School of Nursing, Southern Medical University, China (the principal investigator)
Suting Liu, Nursing and Midwifery Evidence-based Center, School of Nursing, Southern Medical University, China
Yuanyuan Luo, Nursing and Midwifery Evidence-based Center, School of Nursing, Southern Medical University, China
Lei Shi, Nursing and Midwifery Evidence-based Center, School of Nursing, Southern Medical University, China
Lili Zhang, Nursing and Midwifery Evidence-based Center, School of Nursing, Southern Medical University, China
Jinhui Tian, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China

Further Study Information

Current Stage: Ongoing
Date: June 2021 - April 2022
Funding source(s):


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: First and second degree perineal tears

Target Population

Age Range: 0 - 60

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers

Study Type

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

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review

The development of this COS will be guided by an advisory group composed of clinicians, senior midwives. senior nurses, patients, and methodologists. This study will include a systematic review of the literature to identify outcomes that have been reported in prior studies in this area. A semi-structured interview with clinicians, nurses, and pregnant women will be conducted to collect their opinions on important outcomes. Key stakeholders shall then prioritize these outcomes using a Delphi study. A face-to-face consensus meeting shall be held with stakeholders to determine the list of outcomes included in the final COS.

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