Adjunctive Azithromycin Prophylaxis for Cesarean Delivery
Alan T N Tita, Jeff M Szychowski, Kim Boggess, George Saade, Sherri Longo, Erin Clark, Sean Esplin, Kirsten Cleary, Ron Wapner, Kellett Letson, Michelle Owens, Adi Abramovici, Namasivayam Ambalavanan, Gary Cutter, William Andrews, C/SOAP Trial Consortium, Rachel LeDuke, Janatha Grant, Lee Ann Merin, Marci Tew, Gloria Adam, Zhara Rahman, Rebecca Quinn, Yukiko Nakamura Orange, Christopher Parks, Richard Mailhot, Victoria Jauk, Robin Steele, Sue Cliver, Ashutosh Tamhane, Karen Dorman, Linda Manor, Sue Pope, Carmen Beamon, Beth Morgan, Ester Godbold, Cecelia Recabarren, Maria Bahena, Brenda Aguillon, Virginia Huaracha, Maria Wilson-Jimenez, Lisa Garcia, Massomeh Ehsani, Sa Tran, Christine Servay, Barbara Conley, Pat Pandya, Elaine Lofland, Kim Potthoff, Vanessa Johnson, Kedra Wallace, James N Martin, Richard Ogletree, Michael Varner, Shanna Salmon, Suzanne Timothy, Amber Sowles, Kim Hill, Winter Redd, Amanda Behunin, Sandi Dellerman, Michael Nunley, Richard Cox, Melissa Hofer, Caroline Torres, Connie Eng, Sean Blackwell, M Hutchison, Paula Givens, Felecia Ortiz, Vu Ta, Christine Wong, Michael George, Alan T N Tita, Jeff M Szychowski, Kim Boggess, George Saade, Sherri Longo, Erin Clark, Sean Esplin, Kirsten Cleary, Ron Wapner, Kellett Letson, Michelle Owens, Adi Abramovici, Namasivayam Ambalavanan, Gary Cutter, William Andrews, C/SOAP Trial Consortium, Rachel LeDuke, Janatha Grant, Lee Ann Merin, Marci Tew, Gloria Adam, Zhara Rahman, Rebecca Quinn, Yukiko Nakamura Orange, Christopher Parks, Richard Mailhot, Victoria Jauk, Robin Steele, Sue Cliver, Ashutosh Tamhane, Karen Dorman, Linda Manor, Sue Pope, Carmen Beamon, Beth Morgan, Ester Godbold, Cecelia Recabarren, Maria Bahena, Brenda Aguillon, Virginia Huaracha, Maria Wilson-Jimenez, Lisa Garcia, Massomeh Ehsani, Sa Tran, Christine Servay, Barbara Conley, Pat Pandya, Elaine Lofland, Kim Potthoff, Vanessa Johnson, Kedra Wallace, James N Martin, Richard Ogletree, Michael Varner, Shanna Salmon, Suzanne Timothy, Amber Sowles, Kim Hill, Winter Redd, Amanda Behunin, Sandi Dellerman, Michael Nunley, Richard Cox, Melissa Hofer, Caroline Torres, Connie Eng, Sean Blackwell, M Hutchison, Paula Givens, Felecia Ortiz, Vu Ta, Christine Wong, Michael George
Abstract
Background: The addition of azithromycin to standard regimens for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin-based extended-spectrum prophylaxis in women undergoing nonelective cesarean section.
Methods: In this trial conducted at 14 centers in the United States, we studied 2013 women who had a singleton pregnancy with a gestation of 24 weeks or more and who were undergoing cesarean delivery during labor or after membrane rupture. We randomly assigned 1019 to receive 500 mg of intravenous azithromycin and 994 to receive placebo. All the women were also scheduled to receive standard antibiotic prophylaxis. The primary outcome was a composite of endometritis, wound infection, or other infection occurring within 6 weeks.
Results: The primary outcome occurred in 62 women (6.1%) who received azithromycin and in 119 (12.0%) who received placebo (relative risk, 0.51; 95% confidence interval [CI], 0.38 to 0.68; P<0.001). There were significant differences between the azithromycin group and the placebo group in rates of endometritis (3.8% vs. 6.1%, P=0.02), wound infection (2.4% vs. 6.6%, P<0.001), and serious maternal adverse events (1.5% vs. 2.9%, P=0.03). There was no significant between-group difference in a secondary neonatal composite outcome that included neonatal death and serious neonatal complications (14.3% vs. 13.6%, P=0.63).
Conclusions: Among women undergoing nonelective cesarean delivery who were all receiving standard antibiotic prophylaxis, extended-spectrum prophylaxis with adjunctive azithromycin was more effective than placebo in reducing the risk of postoperative infection. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; C/SOAP ClinicalTrials.gov number, NCT01235546 .).
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Source: PubMed