C/S: Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques

Sponsor

Kayseri Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02976311

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delivery Cesarean Delivery Inflammation	Procedure: cesarean section(C/S) via the modified Misgav-Ladach technique Procedure: cesarean section via the Pfannenstiel-Kerr technique	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misgav-Ladach cesarean section(C/S) via the modified 'Misgav-Ladach' technique	Procedure: 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	Procedure: cesarean section via the Pfannenstiel-Kerr technique the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique

Arm

Intervention/Treatment

Active Comparator: Misgav-Ladach

cesarean section(C/S) via the modified 'Misgav-Ladach' technique

Procedure: 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

Procedure: cesarean section via the Pfannenstiel-Kerr technique

the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique

Outcome Measures

Primary Outcome Measures

IL-6 [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
TNF-alpha [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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