Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
NCT ID: NCT01235546
Last Updated: 2017-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2013 participants
INTERVENTIONAL
2011-05-31
2015-12-31
Brief Summary
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Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo and standard of care
250 cc normal saline
Placebo and standard of care
250 cc normal saline, plus standard of care (cephazolin or clindamycin)
Azithromycin and Standard of care
500 mg Azithromycin in 250 cc normal saline
Azithromycin and standard of care
500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)
Interventions
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Azithromycin and standard of care
500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)
Placebo and standard of care
250 cc normal saline, plus standard of care (cephazolin or clindamycin)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:
1. Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or
2. Membrane rupture (standardized to duration of at least 4 hours prior to randomization).
Exclusion Criteria
* Multiple pregnancy
* Known azithromycin (or other macrolide) allergy
* Vaginal delivery
* Elective or scheduled cesarean prior to labor or membrane rupture.
* Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment.
* Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
* Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient)
* Fetal demise or major congenital anomaly
* Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
* Significant renal disease defined as serum creatinine known to be \>2.0 mg/dl or on dialysis.
* Active congestive heart failure (EF\<45%) or pulmonary edema
* Active diarrhea at time of delivery
* Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia
* Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval
* Patient currently being treated with efavirenz, nelfinavir or fluconazole
14 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Texas
OTHER
University of North Carolina
OTHER
Mission Hospital
UNKNOWN
Ochsner Health System
OTHER
The University of Texas Health Science Center, Houston
OTHER
Columbia University
OTHER
University of Utah
OTHER
University of Mississippi Medical Center
OTHER
Alan Tita
OTHER
Responsible Party
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Alan Tita
Professor
Principal Investigators
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Alan TN Tita, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Columbia University
New York, New York, United States
Mission Hospital
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Tita ATN, Rouse DJ, Blackwell S, Saade GR, Spong CY, Andrews WW. Emerging concepts in antibiotic prophylaxis for cesarean delivery: a systematic review. Obstet Gynecol. 2009 Mar;113(3):675-682. doi: 10.1097/AOG.0b013e318197c3b6.
Andrews WW, Hauth JC, Cliver SP, Savage K, Goldenberg RL. Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis. Obstet Gynecol. 2003 Jun;101(6):1183-9. doi: 10.1016/s0029-7844(03)00016-4.
Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
Martin JK, Longo SA, Jauk VR, Clark EAS, Saade GR, Boggess KA, Esplin S, Wapner RJ, Owens MY, Blackwell SC, Andrews WW, Szychowski JM, Tita AT. Neonatal outcomes in term and preterm infants following adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery. J Matern Fetal Neonatal Med. 2024 Dec;37(1):2367082. doi: 10.1080/14767058.2024.2367082. Epub 2024 Jun 14.
Sanusi A, Ye Y, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Owens M, Blackwell S, Szychowski JM, Tita ATN, Subramaniam A. Timing of Adjunctive Azithromycin for Unscheduled Cesarean Delivery and Postdelivery Infection. Obstet Gynecol. 2022 Jun 1;139(6):1043-1049. doi: 10.1097/AOG.0000000000004788. Epub 2022 May 2.
Boggess KA, Tita A, Jauk V, Saade G, Longo S, Clark EAS, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Blackwell S, Beamon C, Szychowski JM, Andrews W; Cesarean Section Optimal Antibiotic Prophylaxis Trial Consortium. Risk Factors for Postcesarean Maternal Infection in a Trial of Extended-Spectrum Antibiotic Prophylaxis. Obstet Gynecol. 2017 Mar;129(3):481-485. doi: 10.1097/AOG.0000000000001899.
Tita AT, 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; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
Other Identifiers
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NIH 1R01HD064729-01A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
F090323006
Identifier Type: -
Identifier Source: org_study_id
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