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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

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ClinicalTrials.gov Identifier: NCT00186082
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 15, 2011
Sponsor:
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Complications, Infectious Drug: Cefotetan or Cefoxitin vs placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : September 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2008


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. No perineal breakdown or infection [ Time Frame: Six weeks post partum ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186082     History of Changes
Other Study ID Numbers: 95339
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Pregnancy Complications
Pregnancy Complications, Infectious
Infection
Anti-Bacterial Agents
Clindamycin
Cefoxitin
Cefotaxime
Cefotetan
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action