Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Pregnancy Complications, Infectious Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186082
• Other study ID #: 95339
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 13, 2011
• Start date: September 2003
• Est. completion date: June 2008

Study information

• Verified date: June 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• third and fourth degree perineal laceration

Exclusion Criteria:

• chorioamnionitis, HIV positive, inflammatory bowel disease

Study Design

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Pregnancy Complications, Infectious

Intervention

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.

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Santa Clara Valley Health & Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No perineal breakdown or infection		Six weeks post partum	No