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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

This study has been completed.
Sponsor:
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186082
First received: September 13, 2005
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy Complications, Infectious
 Drug: Cefotetan or Cefoxitin vs placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • No perineal breakdown or infection [ Time Frame: Six weeks post partum ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: September 2003
Study Completion Date: June 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefotetan, Cefoxitin or Clindamycin Drug: Cefotetan or Cefoxitin vs placebo

Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously.

Normal Saline, 100 ml intravenously for placebo arm.
Placebo Comparator: Normal Saline Drug: Cefotetan or Cefoxitin vs placebo

Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously.

Normal Saline, 100 ml intravenously for placebo arm.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- third and fourth degree perineal laceration

Exclusion Criteria:

- chorioamnionitis, HIV positive, inflammatory bowel disease

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186082

Locations
United States, California
Santa Clara Valley Medical Center
San Jose, California, United States
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

Publications:

Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186082     History of Changes
Other Study ID Numbers: 95339
Study First Received: September 13, 2005
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pregnancy Complications
Pregnancy Complications, Infectious
Anti-Bacterial Agents
Cefotetan
 Cefoxitin
Cefotaxime
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013