Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques (C/S)
Primary Purpose
Delivery, Cesarean Delivery, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cesarean section(C/S) via the modified Misgav-Ladach technique
cesarean section via the Pfannenstiel-Kerr technique
Sponsored by

About this trial
This is an interventional diagnostic trial for Delivery focused on measuring inflammatory reaction, IL-6, TNF, Misgav Ladach technique, Pfannenstiel-Kerr technique, cesarean delivery, cesarean technique
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Misgav-Ladach
Pfannenstiel-Kerr
Arm Description
cesarean section(C/S) via the modified 'Misgav-Ladach' technique
cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique
Outcomes
Primary Outcome Measures
IL-6
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
TNF-alpha
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02976311
First Posted
November 22, 2016
Last Updated
November 24, 2016
Sponsor
Kayseri Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02976311
Brief Title
Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques
Acronym
C/S
Official Title
Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kayseri Education and Research Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery, Cesarean Delivery, Inflammation
Keywords
inflammatory reaction, IL-6, TNF, Misgav Ladach technique, Pfannenstiel-Kerr technique, cesarean delivery, cesarean technique
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misgav-Ladach
Arm Type
Active Comparator
Arm Description
cesarean section(C/S) via the modified 'Misgav-Ladach' technique
Arm Title
Pfannenstiel-Kerr
Arm Type
Active Comparator
Arm Description
cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique
Intervention Type
Procedure
Intervention Name(s)
cesarean section(C/S) via the modified Misgav-Ladach technique
Intervention Description
the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique
Intervention Type
Procedure
Intervention Name(s)
cesarean section via the Pfannenstiel-Kerr technique
Intervention Description
the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
Primary Outcome Measure Information:
Title
IL-6
Description
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
Time Frame
24 hours
Title
TNF-alpha
Description
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
If needed
Learn more about this trial
Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques
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