Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs - Full Text View

Sponsor:	Stanford University
Collaborator:	Santa Clara Valley Health & Hospital System
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186082

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:

MedlinePlus related topics: Antibiotics Postpartum Care

Drug Information available for: Cefoxitin sodium Cefoxitin Cefotaxime Cefotetan Cefotetan disodium

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:

Duggal N, Mercado C, Daniels K, Bujor A, Caughey AB, El-Sayed YY. Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1268-73.

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 February 09, 2012