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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
Kayseri Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    November 22, 2016
    Last Updated
    November 24, 2016
    Sponsor
    Kayseri Education and Research Hospital
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    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

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