Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

This study has been completed.

Sponsor:

Information provided by:

Attikon Hospital

ClinicalTrials.gov Identifier:

NCT01138852

First received: June 4, 2010

Last updated: NA

Last verified: July 2004

History: No changes posted

Tracking Information
First Received Date ^ICMJE	June 4, 2010
Last Updated Date	June 4, 2010
Start Date ^ICMJE	July 2004
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
Official Title ^ICMJE	Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
Brief Summary	The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed. Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.
Detailed Description	The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed. The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection. A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Surgical Site Infections
Intervention ^ICMJE	Drug: Ampicillin-sulbactam Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped Drug: Cefuroxime Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped
Study Arm (s)	Experimental: ampicillin-sulbactam This is the drug used to prevent post-cesarean infection Interventions: Drug: Ampicillin-sulbactam Drug: Cefuroxime Active Comparator: cefuroxime This drug was compared to ampicillin sulbactam for prevention of infection Interventions: Drug: Ampicillin-sulbactam Drug: Cefuroxime
Publications *	Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	176
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: - All patients undergoing a cesarean delivery were eligible. Exclusion Criteria: Patients with known hypersensitivity to penicillin or cephalosporins. Patients who required concomitant antibiotic therapy during surgery. Patients who have received antibiotics during the 72 hours immediately preceding their enrollment. Patients whose postpartum fever was clearly associated with other known causes.
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01138852
Other Study ID Numbers ^ICMJE	UHATpro1
Has Data Monitoring Committee	Yes
Responsible Party	Eleftherios Ziogos, Department of Obstetrics and Gynecology, Nikaia's Regional General Hospital "Agios Panteleimon", Pireaus, Department of Obstetrics and Gynecology, Nikaia's Regional General Hospital "Agios Panteleimon", Pireaus and Department of Infectious Disease Attikon General Hospital
Study Sponsor ^ICMJE	Attikon Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Attikon Hospital
Verification Date	July 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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