Abstract
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.
Keywords
cesarean delivery - pregnancy - infection - systematic review - core outcomes