Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

Stanford University

Status: Completed

Conditions: Pregnancy Complications, Infectious

Treatments: Drug: Cefotetan or Cefoxitin vs placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00186082

95339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• third and fourth degree perineal laceration

Exclusion criteria

• chorioamnionitis, HIV positive, inflammatory bowel disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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147 participants in 2 patient groups, including a placebo group

Cefotetan, Cefoxitin or Clindamycin

Active Comparator group

Treatment:

Drug: Cefotetan or Cefoxitin vs placebo

Normal Saline

Placebo Comparator group

Treatment:

Drug: Cefotetan or Cefoxitin vs placebo