Kim A Boggess1, Alan Tita, Victoria Jauk, George Saade, Sherri Longo, Erin A S Clark, Sean Esplin, Kristin Cleary, Ronald Wapner, Kelli Letson, Michelle Owens, Sean Blackwell, Carmen Beamon, Jeffrey M Szychowski, William Andrews. 1. University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; the University of Alabama at Birmingham, Birmingham, Alabama; the University of Texas Medical Branch, Galveston, Texas; Oshner Health System, New Orleans, Louisiana; the University of Utah and Intermountain Health-LC, Salt Lake City, Utah; Columbia University, New York, New York; Mission Hospital, Asheville, North Carolina; the University of Mississippi at Jackson, Jackson, Mississippi, the University of Houston at Houston, Houston, Texas; and WakeMed Physician Practices, Raleigh, North Carolina.
Abstract
OBJECTIVE: To identify maternal clinical risk factors for postcesarean maternal infection in a randomized clinical trial of preincision extended-spectrum antibiotic prophylaxis. METHODS: We conducted a planned secondary analysis of a randomized clinical trial. Patients were 24 weeks of gestation or greater and delivered by cesarean after a minimum of 4 hours of ruptured membranes or labor. All participants received standard preincision prophylaxis and were randomized to receive azithromycin or placebo. The primary outcome for this analysis is maternal infection: a composite outcome of endometritis, wound infection (superficial or deep), or other infections occurring up to 6 weeks postpartum. Maternal clinical characteristics associated with maternal infection, after controlling for azithromycin assignment, were identified. These maternal factors were included in a multivariable logistic regression model for maternal infection. RESULTS: Of 2,013 patients, 1,019 were randomized toazithromycin. Overall, 177 (8.8%) had postcesarean maternal infection. In the final adjusted model, compared with the reference groups, women of black race-ethnicity, with a nontransverse uterine incision, with duration of membrane rupture greater than 6 hours, and surgery duration greater than 49 minutes, were associated higher odds of maternal infection (all with adjusted odds ratios [ORs] of approximately 2); azithromycin was associated with lower odds of maternal infection (adjusted OR 0.4, 95% confidence interval 0.3-0.6). CONCLUSION: Despite preincision azithromycin-based extended-spectrum antibiotic prophylaxis, postcesarean maternal infection remains a significant source of morbidity. Recognition of risk factors may help guide innovative prevention strategies. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT012235546.
RCT Entities:
OBJECTIVE: To identify maternal clinical risk factors for postcesarean maternal infection in a randomized clinical trial of preincision extended-spectrum antibiotic prophylaxis. METHODS: We conducted a planned secondary analysis of a randomized clinical trial. Patients were 24 weeks of gestation or greater and delivered by cesarean after a minimum of 4 hours of ruptured membranes or labor. All participants received standard preincision prophylaxis and were randomized to receive azithromycin or placebo. The primary outcome for this analysis is maternal infection: a composite outcome of endometritis, wound infection (superficial or deep), or other infections occurring up to 6 weeks postpartum. Maternal clinical characteristics associated with maternal infection, after controlling for azithromycin assignment, were identified. These maternal factors were included in a multivariable logistic regression model for maternal infection. RESULTS: Of 2,013 patients, 1,019 were randomized to azithromycin. Overall, 177 (8.8%) had postcesarean maternal infection. In the final adjusted model, compared with the reference groups, women of black race-ethnicity, with a nontransverse uterine incision, with duration of membrane rupture greater than 6 hours, and surgery duration greater than 49 minutes, were associated higher odds of maternal infection (all with adjusted odds ratios [ORs] of approximately 2); azithromycin was associated with lower odds of maternal infection (adjusted OR 0.4, 95% confidence interval 0.3-0.6). CONCLUSION: Despite preincision azithromycin-based extended-spectrum antibiotic prophylaxis, postcesarean maternal infection remains a significant source of morbidity. Recognition of risk factors may help guide innovative prevention strategies. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT012235546.
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