Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section - Full Text View

Purpose

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.

Condition	Intervention	Phase
Surgical Site Infections	Drug: Ampicillin-sulbactam Drug: Cefuroxime	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Ampicillin sodium Ampicillin Ampicillin trihydrate Cefuroxime Cefuroxime sodium Cefuroxime axetil Sulbactam Sulbactam sodium

U.S. FDA Resources

Further study details as provided by Attikon Hospital:


Enrollment:	176
Study Start Date:	July 2004
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ampicillin-sulbactam This is the drug used to prevent post-cesarean infection	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
Active Comparator: cefuroxime This drug was compared to ampicillin sulbactam for prevention of infection	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

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.

Eligibility


Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided by Attikon Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1186/1471-2334-10-341.


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
ClinicalTrials.gov Identifier:	NCT01138852 History of Changes
Other Study ID Numbers:	UHATpro1
Study First Received:	June 4, 2010
Last Updated:	June 4, 2010
Health Authority:	Ethics Committee,Nikaia's Regional General Hospital "Agios Panteleimon" Greece:

Keywords provided by Attikon Hospital:


post-cesarean infections ampicillin-sulbactam cefuroxime cesarean

Additional relevant MeSH terms:


Ampicillin Cefuroxime Cefuroxime axetil Sulbactam Sultamicillin Anti-Bacterial Agents	Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015