Developing a Core Outcome Set for Cesarean Delivery Maternal Infectious Morbidity Outcomes.

Objective: This study aimed to develop a core outcome set of primary outcomes for studies involving cesarean deliveries with infectious morbidity outcomes.
Study Design: Authors reported primary outcomes from 11 Cochrane systematic reviews (SRs), 12 other SRs, and 327 randomized controlled trials (RCTs). These outcomes were condensed into 20 primary outcome groups. Next, a modified Delphi technique was used to gain consensus on key outcomes. Authors from included SRs were sent a questionnaire consisting of a free response and multiple-choice questions. These data were used to propose a set of core outcomes.
Results: The most frequent outcomes in RCTs were composite "infectious outcomes" (24%) with the second most common being endometritis (12%). The most common reported SR outcomes were wound infection (21%) and endometritis (16%). For the Delphi survey free response portion, wound infection (88%) and endometritis (79%) were the most commonly endorsed outcomes. Chosen list outcomes were maternal mortality (83%), wound infection (83%), wound complications (86%), and postpartum endometritis (80%). The proposed final core outcome set for cesarean trials was endometritis (primary outcome), maternal mortality, wound infection, wound complications, febrile morbidity, and neonatal morbidity.
Conclusion: Utilizing defined core outcomes in all studies of cesarean section can harmonize trial reports and allow data synthesis for meta-analyses.
Competing Interests: None declared.
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