Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Not Applicable

Completed

• Conditions: Pregnancy Complications, Infectious
• Interventions: Drug: Cefotetan or Cefoxitin vs placebo

• Registration Number: NCT00186082
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-06
• Study Completion: 2008-06
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

• third and fourth degree perineal laceration

Exclusion Criteria

• chorioamnionitis, HIV positive, inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Saline	Cefotetan or Cefoxitin vs placebo	-
Cefotetan, Cefoxitin or Clindamycin	Cefotetan or Cefoxitin vs placebo	-

Primary Outcome Measures

Name	Time	Method
No perineal breakdown or infection	Six weeks post partum

Trial Locations

Locations (2)

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States