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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Primary Purpose

Pregnancy Complications, Infectious

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefotetan or Cefoxitin vs placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Complications, Infectious

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: - third and fourth degree perineal laceration Exclusion Criteria: - chorioamnionitis, HIV positive, inflammatory bowel disease

Sites / Locations

  • Santa Clara Valley Medical Center
  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cefotetan, Cefoxitin or Clindamycin

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

No perineal breakdown or infection

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 13, 2011
Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System
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1. Study Identification

Unique Protocol Identification Number
NCT00186082
Brief Title
Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Infectious

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefotetan, Cefoxitin or Clindamycin
Arm Type
Active Comparator
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cefotetan or Cefoxitin vs placebo
Intervention Description
Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm.
Primary Outcome Measure Information:
Title
No perineal breakdown or infection
Time Frame
Six weeks post partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - third and fourth degree perineal laceration Exclusion Criteria: - chorioamnionitis, HIV positive, inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Yehia El-Sayed
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18515507
Citation
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. doi: 10.1097/AOG.0b013e31816de8ad.
Results Reference
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Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

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