Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques

Inflammation Clinical Trial

— C/S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976311
• Other study ID #: E52332816_51
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: November 24, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cesarean Delivery
• Delivery
• Inflammation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	Yes
Primary	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	24 hours	Yes