NCT00186082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

June 13, 2011

Conditions

Pregnancy Complications, Infectious

Outcome Measures

Primary Outcomes (1)

  • No perineal breakdown or infection

    Six weeks post partum

Study Arms (2)

Cefotetan, Cefoxitin or Clindamycin

ACTIVE COMPARATOR
Drug: Cefotetan or Cefoxitin vs placebo

Normal Saline

PLACEBO COMPARATOR
Drug: Cefotetan or Cefoxitin vs placebo

Interventions

Cefotetan or Cefoxitin vs placeboDRUG

Cefotetan or Cefoxitin, 1 g intravenously, or Clindamycin, 900 mg intravenously. Normal Saline, 100 ml intravenously for placebo arm.

Cefotetan, Cefoxitin or ClindamycinNormal Saline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- third and fourth degree perineal laceration

You may not qualify if:

  • \- chorioamnionitis, HIV positive, inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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.

    PMID: 18515507RESULT

MeSH Terms

Conditions

Pregnancy Complications, Infectious

Interventions

Cefotetan

Condition Hierarchy (Ancestors)

InfectionsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yasser Yehia El-Sayed

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2008

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

US(2)