A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs

Stanford University2 sites in 1 country147 target enrollmentSeptember 2003

ConditionsPregnancy Complications, Infectious

InterventionsCefotetan or Cefoxitin vs placebo

DrugsCefotetan or Cefoxitin vs placebo

Overview

Phase: Not Applicable
Intervention: Cefotetan or Cefoxitin vs placebo
Conditions: Pregnancy Complications, Infectious
Sponsor: Stanford University
Enrollment: 147
Locations: 2
Primary Endpoint: No perineal breakdown or infection
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

Detailed Description

After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

June 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group