ATLANTA (Feb. 1, 2016)--In a study to be presented on Feb. 4 in an oral concurrent session at 8 a.m. EST, at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting™, in Atlanta, researchers with the University of Alabama at Birmingham, Center for Women's Reproductive Health; University of North Carolina--Chapel Hill; University of Texas Medical Branch, Galveston; Ochsner, New Orleans, La.; University of Utah and Intermountain Health Care, Salt Lake City; Columbia University, New York City; Mission Hospital, Ashville, N.C.; University of Mississippi, Jackson; and University of Texas, Houston present findings from a study that looked at the benefit of using adjunctive azithromycin to prevent infections after cesarean delivery.
A cephalosporin antibiotic has been used as the standard to prevent infections in women undergoing cesarean delivery; however, this study looked at using azithromycin as an additional antibiotic. Women having C-sections can suffer from a variety of infections included in the primary outcome. These infections include endometritis, cesarean wound infection, abscess, sepsis, septic pelvic thrombophlebitis, pyelonephritis, pneumonia and meningitis. Secondary outcomes include neonatal morbidities and adverse effects. The usual antibiotics being used may not always reduce these infections because they do not control some organisms such as Ureaplasmas, which are frequently associated with post-cesarean delivery infections.
The study, titled Azithromycin-based extended spectrum antibiotic prophylaxis for non-elective cesarean delivery; a pragmatic multicenter placebo-controlled double-blind randomized, controlled trial, looked at women with singletons who had C-sections during labor labor or at least four hours after membrane rupture. All women received the standard antibiotic. Subjects were randomized to also receive either 500mg azithromycin or identical placebo. Study medication was given preferably up to one hour pre-incision (or as soon as possible after). Of 17,790 women screened from April 2011 to November 2014, 2,013 women were randomized to the azithromycin (1,019) or the placebo (994) at 14 sites.
"Pregnancy-associated infection is a major cause of death; our findings support the use of azithromycin in addition to the standard cephalosporin for cesarean delivery in women at high risk of infection," stated Alan Tita, M.D., Ph.D., professor of the Department of Obstetrics and Gynecology and Center for Women's Reproductive Health at the University of Alabama in Birmingham. Dr. Tita will present the findings at the SMFM annual meeting.
The conclusion was that adding azithromycin to the usual antibiotic for non-elective cesarean delivery reduced post-cesarean delivery infections and severe adverse maternal events at no difference in neonatal outcomes.
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A copy of the abstract is available at http://www.smfmnewsroom.org and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).
The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed. For more information visit http://www.smfm.org.
Abstract 3: Azithromycin-based extended spectrum antibiotic prophylaxis for non-elective cesarean delivery: a pragmatic multicenter placebo-controlled double-blind rct
Authors: Alan Tita1, Jeff Szychowski1, Kim Boggess2, George Saade3, Sherri Longo4, Erin Clark5, Sean Esplin5, Kirsten Cleary6, Ron Wapner7, Kellett Letson8, Michelle Owens9, Adi Abramovici10, Namasivayam Ambalavanan11, Gary Cutter12, William Andrews1
1University of Alabama at Birmingham, Center for Women's Reproductive Health, Birmingham, AL, , 2University of North Carolina - Chapel Hill, Chapel Hill, NC, 3University of Texas Medical Branch, Galveston, TX, 4Ochsner, New Orleans, LA, 5University Of Utah and Intermountain Health Care, Salt Lake City, UT, 6Columbia University, New York City, NY, 7Columbia University, New York, NY, 8Mission Hospital, Ashville, NC, 9University of Mississippi, Jackson, MS, 10UT Houston, Houston, TX, 11University of Alabama at Birmingham, Division of Neonatology, Birmingham, AL, 12University of Alabama at Birmingham, Birmingham, AL
Objective: Standard antibiotic prophylaxis (AP) for Cesarean delivery (CD) does not cover some organisms such as Ureaplasmas, which are frequently associated with post-CD infections. We evaluated the effect of adding azithromycin (AZI) to usual AP on post-CD infections in women undergoing non-elective CD.
Study Design: The multicenter double-blind C/SOAP RCT (CT.gov NCT01235546), included women with singletons ?24 wks' GA who had CD during labor or at least 4 hrs after membrane rupture. All women received standard AP. Subjects were randomized to also receive either AZI (500mg in 250ml saline) or identical placebo (250ml saline) by a center-stratified computer-generated scheme. Study medication was given preferably up to 1 hr pre-incision (or as soon as possible after). The centrally adjudicated primary outcome was a composite of endometritis, wound infection, or other infection (abdominopelvic abscess, sepsis, pelvic septic thrombophlebitis, pyelonephritis, pneumonia or meningitis) within 6 wks. Secondary outcomes included neonatal morbidities and reported adverse events. We estimated that N=2000 would be needed to show a ?33% reduction in the primary outcome from a baseline of 8-12% with 80% power and 2-sided alpha of 0.05. Analysis was by intent-to-treat.
Results: Of 17,790 women screened from 04/2011 to 11/2014, 2013 were randomized to AZI (n=1019) or placebo (n=994) at 14 sites. Groups were similar at baseline (35% Caucasian, 34% Black, 29% Latino and mean BMI of 29.9). Drug was administered before incision in 88% per group. The primary outcome occurred significantly less in the AZI group compared to placebo (Table; 6 vs 12%, p <.0001). Postpartum readmissions or emergency visits for any reason were also lower in the AZI group (Table). Neonatal outcomes were similar. Severe adverse maternal events (1.5% vs. 2.9%; p=.026) but not neonatal were less frequently reported with AZI.
Conclusion: Adding AZI to usual AP for non-elective CD reduced post-CD infections (NNT=17) and severe adverse maternal events with no difference in neonatal outcomes.