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

Research output: Contribution to journalArticle

57 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1231-1241
Number of pages11
JournalNew England Journal of Medicine
Volume375
Issue number13
DOIs
StatePublished - Sep 29 2016

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Azithromycin
Antibiotic Prophylaxis
Placebos
Endometritis
Wound Infection
Infection
Pregnancy
Cesarean Section
Rupture
Mothers
Confidence Intervals
Safety
Membranes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Tita, A. T. N., Szychowski, J. M., Boggess, K., Saade, G., Longo, S., Clark, E., ... Andrews, W. (2016). Adjunctive azithromycin prophylaxis for cesarean delivery. New England Journal of Medicine, 375(13), 1231-1241. https://doi.org/10.1056/NEJMoa1602044

Adjunctive azithromycin prophylaxis for cesarean delivery. / Tita, Alan T N; Szychowski, Jeff M.; Boggess, Kim; Saade, George; Longo, Sherri; Clark, Erin; Esplin, Sean; Cleary, Kirsten; Wapner, Ron; Letson, Kellett; Owens, Michelle; Abramovici, Adi; Ambalavanan, Namasivayam; Cutter, Gary; Andrews, William.

In: New England Journal of Medicine, Vol. 375, No. 13, 29.09.2016, p. 1231-1241.

Research output: Contribution to journalArticle

Tita, ATN, Szychowski, JM, Boggess, K, Saade, G, Longo, S, Clark, E, Esplin, S, Cleary, K, Wapner, R, Letson, K, Owens, M, Abramovici, A, Ambalavanan, N, Cutter, G & Andrews, W 2016, 'Adjunctive azithromycin prophylaxis for cesarean delivery', New England Journal of Medicine, vol. 375, no. 13, pp. 1231-1241. https://doi.org/10.1056/NEJMoa1602044
Tita ATN, Szychowski JM, Boggess K, Saade G, Longo S, Clark E et al. Adjunctive azithromycin prophylaxis for cesarean delivery. New England Journal of Medicine. 2016 Sep 29;375(13):1231-1241. https://doi.org/10.1056/NEJMoa1602044
Tita, Alan T N ; Szychowski, Jeff M. ; Boggess, Kim ; Saade, George ; Longo, Sherri ; Clark, Erin ; Esplin, Sean ; Cleary, Kirsten ; Wapner, Ron ; Letson, Kellett ; Owens, Michelle ; Abramovici, Adi ; Ambalavanan, Namasivayam ; Cutter, Gary ; Andrews, William. / Adjunctive azithromycin prophylaxis for cesarean delivery. In: New England Journal of Medicine. 2016 ; Vol. 375, No. 13. pp. 1231-1241.
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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.",
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AU - Tita, Alan T N

AU - Szychowski, Jeff M.

AU - Boggess, Kim

AU - Saade, George

AU - Longo, Sherri

AU - Clark, Erin

AU - Esplin, Sean

AU - Cleary, Kirsten

AU - Wapner, Ron

AU - Letson, Kellett

AU - Owens, Michelle

AU - Abramovici, Adi

AU - Ambalavanan, Namasivayam

AU - Cutter, Gary

AU - Andrews, William

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N2 - 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.

AB - 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.

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