Clinical Trials Directory

Trials / Completed

CompletedNCT00186082

Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
147 (actual)
Sponsor
Stanford University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCefotetan or Cefoxitin vs placeboCefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm.

Timeline

Start date
2003-09-01
Primary completion
2006-06-01
Completion
2008-06-01
First posted
2005-09-16
Last updated
2011-06-15

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00186082. Inclusion in this directory is not an endorsement.