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

Area of Science:

• Obstetrics and Gynecology
• Infectious Diseases
• Clinical Trial Methodology

Background:

• Cesarean deliveries are associated with significant infectious morbidity.
• Current studies on cesarean deliveries lack standardized primary outcome reporting.
• Harmonizing outcome measures is crucial for reliable data synthesis.

Purpose of the Study:

• To develop a core outcome set for primary outcomes in cesarean delivery studies focusing on infectious morbidity.
• To establish a consensus-based set of essential outcomes for cesarean section research.

Main Methods:

• Systematic review of primary outcomes from 11 Cochrane and 12 other systematic reviews, plus 327 randomized controlled trials (RCTs).
• Condensation of reported outcomes into 20 primary outcome groups.
• Modified Delphi technique involving expert authors to achieve consensus on key outcomes.

Main Results:

• The most frequent outcomes reported in RCTs were composite infectious outcomes (24%) and endometritis (12%).
• Wound infection (21%) and endometritis (16%) were most common in systematic reviews.
• The Delphi survey identified maternal mortality, wound infection, wound complications, and postpartum endometritis as highly endorsed outcomes.
• The proposed core outcome set includes endometritis, maternal mortality, wound infection, wound complications, febrile morbidity, and neonatal morbidity.

Conclusions:

• A standardized core outcome set for cesarean delivery trials is proposed.
• Implementation of this core outcome set will harmonize trial reporting.
• This standardization will facilitate robust data synthesis for meta-analyses.