Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques (C/S)
November 24, 2016 updated by: Hatice Akkaya, Kayseri Education and Research Hospital
Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique
In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.
Study Overview
Status
Completed
Conditions
Detailed Description
Cesarean section is one of the most undertaken operations in women of childbearing age.
However, there is not a unique cesarean surgery technique.
Pfannenstiel , reported his own technique in 1897.
Because of the applicability of the technique, it went down well among obstetricians.
After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr technique became the method of choice until late 70's.
In 1972, Stark et al defined the Misgav Ladach technique and in the following years this technique became popular among obstetricians.
In late 80's Misgav Ladach technique was modified and started to be more popular.
But, still Pfannenstiel-Kerr technique continued to be used frequently and studies comparing clinical outcomes of these two techniques were conducted for several times.
However, the inflammatory responses which occured subsequent to application of these techniques were not investigated.
This is the first study investigating the inflammatory response emerged after different cesarean surgery techniques.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Cesarean section for the first time
- Term,singleton pregnancy
Exclusion Criteria:
- Any inflammatory disease
- Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture of membranes
- Pregnancies <37weeks gestational age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Misgav-Ladach
cesarean section(C/S) via the modified 'Misgav-Ladach' technique
|
the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique
|
|
Active Comparator: Pfannenstiel-Kerr
cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique
|
the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-6
Time Frame: 24 hours
|
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
|
24 hours
|
|
TNF-alpha
Time Frame: 24 hours
|
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 22, 2016
First Submitted That Met QC Criteria
November 24, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 24, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E52332816_51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
If needed
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.