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ObesityNCT00980486

Obesity and Antibiotic Tissue Concentration

An observational study of Obesity, run by MemorialCare at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
How many people
31 participants
Where
2 sitesUnited States
Study dates
Jun 2009to Jun 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients requiring cesarean delivery under non-emergent circumstances

Who may be able to join

  • Patients at term (> 37 weeks) undergoing a cesarean delivery.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Women's Pavilion at Miller Children's Hospital

    Long Beach, California, 90806

  • University of California Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: Effects of Maternal Obesity on Tissue Concentrations of Prophylactic Antibiotics During Cesarean Delivery

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.

Read the detailed description

The majority of information regarding pharmacokinetics and pharmacodynamics (the action, properties and elimination of a drug in the body) of antibiotics is based on measurements of the serum and plasma concentrations. Current guidelines for surgical antibiotic prophylaxis have clearly demonstrated appropriate therapeutic levels within blood and serum levels, resulting in low incidence of postoperative bacteremia (bacteria in the blood) and sepsis (infection). Despite this, surgical site infections (SSI) remain the most common postoperative complication, affecting up to 20% of patients undergoing intra-abdominal surgery. Inadequate antibiotic penetration into the tissues of the surgical site, in spite of therapeutic serum levels, results in an environment that is susceptible to pathogens and subsequent infections. Antimicrobial tissue levels are influenced by volume of distribution, regional blood flow and biological properties of tissue. The ability of any drug to reach the tissue of interest is dictated by the relative amount of blood flow to that organ. While lungs and kidneys enjoy a robust blood supply, subcutaneous adipose tissue (fat) (the most frequent site of surgical site infections) receives a small fraction of the cardiac output. Obesity creates an increased volume of distribution, thereby resulting in a greater dilution of antibiotics when compared to non-obese subjects. Moreover, this change in volume of distribution is achieved primarily by increasing the relative amount of poorly perfused adipose tissue. Therefore, it should come as no surprise that obesity is a significant risk factor for surgical site infections.

The rate of obesity in the United States has shown a steady increase and more than doubled in the last twenty-five years from 15% in 1980 to 32.9% in 2004. Moreover, nearly one third of women of reproductive age are obese and approximately 6% are extremely obese. In addition to the usual health related concerns, obesity significantly increases the rate of complications associated with pregnancy. In particular, several studies have demonstrated an increased incidence of cesarean delivery associated to maternal obesity. Cesarean delivery rates, much like obesity rates, have witnessed a tremendous surge in the last few decades and now account for approximately 30% of all deliveries or nearly 1.2 million procedures. Surgical site infections associated with cesarean delivery include wound infections and endomyometritis (infection in the uterus), with rates ranging from 7% to 20% depending on the demographic and obstetric variables. Despite these alarming trends there is a paucity of data regarding antimicrobial activity of prophylactic antibiotics in tissues and the effects of maternal obesity on these concentrations at the time of cesarean delivery.

While the rates of cesarean deliveries have reached a plateau at around 30% in recent years, the rates of obesity continue to climb unabated. As the attributes of the population evolve over the course of time so must the guidelines and management adapt to the individuals in our care.

Conditions
Obesity
Keywords
Antibiotic Concentration, Tissue, Obesity, Cesarean
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00980486
Study groupRoleWhat they receive
BMI <30BMI <30
BMI 30-39BMI 30-39
BMI >40BMI >40

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (1)
  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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980486
Sponsor's protocol ID
587-08
Status last verified
Sep 2010
First submitted
18 Sep 2009
Last updated
8 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21422859

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by MemorialCare at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.

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