AzTrials
AzTrials

ObesityNCT01836315

Inflammation in Obese Parturients: Surgical Outcomes After Elective Caesarean Section

An observational study of Obesity and Pregnancy, run by University of Manitoba at 1 site in Canada.

Completed

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

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Obesity, Pregnancy, Cesarean Section
What is being tested?
Observational Study
How many people
25 participants
Where
1 siteCanada
Study dates
Jan 2013to Dec 2013
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 to 45 years
  • Women only
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • Any acute or chronic medical illness acquired before or during pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Health Sciences Center

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

About this study

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.

Read more

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.

Being tested
Observational Study
Medical subject headings
Obesity

What participants receive

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

  • Observational StudyOther

    Also called Observational Study Only

Study groups in NCT01836315
Study groupRoleWhat they receive
ObeseDefined by a BMI >35 kg/M2
Receives: Other: Observational Study
Non-ObeseDefined by a BMI <35 kg/M2
Receives: Other: Observational Study

What is being measured

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

  1. Level of inflammatory biomarkers

    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)).

    Measured: 2 days

Secondary outcomes (1)
  1. Incidence of postoperative wound infections

    Measured: 28 days

Timeline

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

  1. First posted19 Apr 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01836315
Sponsor's protocol ID
B2012:123
Status last verified
Dec 2013
First submitted
16 Apr 2013
Last updated
10 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Pregnancy, run by University of Manitoba at 1 site in Canada.

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 3 inclusion and 1 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Level of inflammatory biomarkers (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Dec 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in