Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs

NCT ID: NCT00186082

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Complications, Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cefotetan, Cefoxitin or Clindamycin

Group Type ACTIVE_COMPARATOR

Cefotetan or Cefoxitin vs placebo

Intervention Type DRUG

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

Normal Saline, 100 ml intravenously for placebo arm.

Normal Saline

Group Type PLACEBO_COMPARATOR

Cefotetan or Cefoxitin vs placebo

Intervention Type DRUG

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

Normal Saline, 100 ml intravenously for placebo arm.

Interventions

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Cefotetan or Cefoxitin vs placebo

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

Normal Saline, 100 ml intravenously for placebo arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- third and fourth degree perineal laceration

Exclusion Criteria

\- chorioamnionitis, HIV positive, inflammatory bowel disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Santa Clara Valley Health & Hospital System

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18515507 (View on PubMed)

Other Identifiers

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95339

Identifier Type: -

Identifier Source: org_study_id

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