Obesity and Antibiotic Tissue Concentration
Effects of Maternal Obesity on Tissue Concentrations of Prophylactic Antibiotics During Cesarean Delivery
1 other identifier
observational
31
1 country
2
Brief Summary
The purpose of this study is to determine whether the dose of prophylactic antibiotics at the time of cesarean delivery requires adjustment in obese and overweight patients in order to achieve optimal antimicrobial activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2009
Shorter than P25 for all trials
2 active sites
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
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 8, 2010
September 1, 2010
1 year
September 18, 2009
October 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery.
6 weeks
Secondary Outcomes (1)
To assess the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery.
6 weeks
Study Arms (3)
BMI <30
BMI \<30
BMI 30-39
BMI 30-39
BMI >40
BMI \>40
Eligibility Criteria
All patients requiring cesarean delivery under non-emergent circumstances
You may qualify if:
- Patients at term (\> 37 weeks) undergoing a cesarean delivery.
You may not qualify if:
- Women younger than 18 years,
- Pre-gestational diabetes,
- Chronic hypertension,
- Collagen vascular disease,
- Multiple gestation,
- Contraindications to cefazolin administration (known anaphylactic reaction to penicillins or known cephalosporin allergy),
- Any exposure to cephalosporins in one week prior to cesarean section, OR
- Need for emergent cesarean delivery or diagnosis of chorioamnionitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MemorialCarelead
- University of California, Irvinecollaborator
Study Sites (2)
Women's Pavilion at Miller Children's Hospital
Long Beach, California, 90806, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Related Publications (1)
Pevzner L, Swank M, Krepel C, Wing DA, Chan K, Edmiston CE Jr. Effects of maternal obesity on tissue concentrations of prophylactic cefazolin during cesarean delivery. Obstet Gynecol. 2011 Apr;117(4):877-882. doi: 10.1097/AOG.0b013e31820b95e4.
PMID: 21422859DERIVED
Biospecimen
Adipose, myometrial and blood serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Chan, MD
Long Beach Memorial Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2009
First Posted
September 21, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 8, 2010
Record last verified: 2010-09