Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Complications, Infectious Female Urogenital Diseases and Pregnancy Complications Infections Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara Valley Medical Center, San Jose, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

third and fourth degree perineal laceration

Exclusion criteria

chorioamnionitis, HIV positive, inflammatory bowel disease

Treatment and study plan

Cefotetan or Cefoxitin vs placebo

Drug

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

Normal Saline, 100 ml intravenously for placebo arm.

Primary outcomes

No perineal breakdown or infection

Time frame: Six weeks post partum

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

Santa Clara Valley Health & Hospital System

Registry information

Official study title

A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2008
First posted: Sep 16, 2005
Registry last updated: Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed