Adjunctive Azithromycin Prophylaxis for Cesarean Delivery.
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.



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.



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).



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 .).
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Alan T N
AT
Tita
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Jeff M
JM
Szychowski
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Kim
K
Boggess
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
George
G
Saade
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Sherri
S
Longo
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Erin
E
Clark
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Sean
S
Esplin
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Kirsten
K
Cleary
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Ron
R
Wapner
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Kellett
K
Letson
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Michelle
M
Owens
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Adi
A
Abramovici
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Namasivayam
N
Ambalavanan
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
Gary
G
Cutter
From the Departments of Obstetrics and Gynecology (A.T.N.T., J.M.S., W.A.), Biostatistics (J.M.S., G.C.), and Pediatrics (N.A.), University of Alabama at Birmingham, Birmingham; the Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, Chapel Hill (K.B.), and Mission Hospital, Asheville (K.L.) - both in North Carolina; the University of Texas Medical Branch, Galveston (G.S.), and the University of Texas Health Sciences Center, Houston (A.A.); Ochsner Health System, New Orleans (S.L.); the University of Utah (E.C., S.E.) and Intermountain Health Care (E.C., S.E.), Salt Lake City; Columbia University, New York (K.C., R.W.); and the University of Mississippi, Jackson (M.O.).
William
W
Andrews
D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D002585:Cesarean Section; D004716:Endometritis / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011645:Puerperal Infection / Q000517:prevention & control*; D018805:Sepsis / Q000453:epidemiology / Q000517:prevention & control; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016019:Survival Analysis; D055815:Young Adult
D000900:Anti-Bacterial Agents; D017963:Azithromycin
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