Inflammation in Obese Parturients: Surgical Outcomes After Elective Caesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Duane Funk, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01836315
First received: April 16, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

Hypothesis: The investigators propose that obese parturients will have an increased inflammatory response and a decreased anti-inflammatory response to the surgical and anesthetic insult of caesarean section and that this will be associated with a higher rate of perioperative complications, as compared to non-obese parturients.2 Background: Obese patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore, obese patients have a higher incidence of perioperative complications, especially wound infections, and this is well documented in the caesarean section population. The pregnant population is unique as a result of the immunologic changes that occur at baseline, and an increase in pro-inflammatory markers is seen in serum and in placental tissue of obese subjects, and has been demonstrated to correlate with adverse fetal outcomes.

Specific Objectives: To determine the baseline levels of three established markers of inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2 respectively), and examine how they change in response to the stress of surgery/anesthesia. The investigators will correlate the inflammatory response with the incidence of postoperative wound infections.

Methods: Patients will be recruited to the study prior to the planned caesarean section. Blood samples for inflammatory marker levels will be performed preoperatively, immediately postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient charts will be reviewed to determine which patients have experienced surgical complications in the 30 days postoperatively. Surgical complications will then be correlated with the measured levels of inflammatory markers.

Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the investigators would need to study 18 patients per group to prove our hypothesis that inflammatory cytokine levels are correlated with postoperative infections. The investigators plan to study 20 patients per group to account for a potential patient attrition rate of 10% during the study.

Significance/Importance: The connection between obesity and dysregulation of the perioperative inflammatory response has not been well established nor has perioperative inflammation in the obese population been linked to the observed increased in perioperative morbidity. The investigators hope to demonstrate these connections and hopefully will be able to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk of postoperative wound infections with pharmacokinetically targeted antimicrobial prophylaxis.


Condition Intervention
Obesity
Pregnancy
Cesarean Section
Other: Observational Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation in Obese Parturients: Surgical Outcomes After Elective Caesarean Section

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Level of inflammatory biomarkers [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Levels of inflammatory biomarkers (specifically pentraxin-3 (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory marker)).


Secondary Outcome Measures:
  • Incidence of postoperative wound infections [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 25
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese
Defined by a BMI >35 kg/M2
Other: Observational Study
Other Name: Observational Study Only
Non-Obese
Defined by a BMI <35 kg/M2
Other: Observational Study
Other Name: Observational Study Only

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

We will undertake a prospective cohort study to examine the levels of circulating inflammatory cytokines in obese and non-obese parturients undergoing elective cesarean section and correlate them with the rate of postoperative wound infections. We will recruit 20 patients in each arm of the study.

Criteria

Inclusion Criteria:

  • obese (defined as a body bass index (BMI) of greater than 35 kg/M2) or non-obese (BMI <35 kg/M2)
  • female
  • Over 18 years of age

Exclusion Criteria:

  • Any acute or chronic medical illness acquired before or during pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836315

Locations
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Duane Funk, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01836315     History of Changes
Other Study ID Numbers: B2012:123
Study First Received: April 16, 2013
Last Updated: December 6, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014