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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy Complications, Infectious

Intervention: Cefotetan or Cefoxitin vs placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Yasser Yehia El-Sayed, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: No perineal breakdown or infection

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- third and fourth degree perineal laceration

Exclusion Criteria:

- chorioamnionitis, HIV positive, inflammatory bowel disease

Locations and Contacts

Santa Clara Valley Medical Center, San Jose, California, United States

Stanford University School of Medicine, Stanford, California 94305, United States

Additional Information

Starting date: September 2003
Last updated: June 13, 2011

Page last updated: August 20, 2015

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