Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs

October 19, 2015 updated by: MERYEM Kurek EKEN, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

At c-section subject will be randomised into four groups:

Group1: Only visceral peritoneum will be closed

Group 2: Only parietal peritoneum will be closed

Group 3: Both of them will be closed

Group 4: None of them will be closed

During the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34280
        • Recruiting
        • Meryem Kurek EKEN
        • Contact:

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

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women underwent uncomplicated c-section

Exclusion Criteria:

  • Patient with systemic Diseases
  • Pregnant with Obstetric complications
  • Pregnant with two or more previous c-sections

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Only visceral peritoneum will be closed
Group1: Only visceral peritoneum will be closed
Procedure: Group 1: Only visceral peritoneum will be closed
Experimental: Only parietal peritoneum will be closed
Group 2: Only parietal peritoneum will be closed
Procedure: Group 2 : Only parietal peritoneum will be closed
Experimental: Both of them will be closed
Group 3: Both of them will be closed
Procedure: Group 3 : Both of them will be closed
Experimental: None of them will be closed
Group 4: None of them will be closed
Procedure: Group 4: None of them will be closed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative vital sign (arterial tension)
Time Frame: First postoperative hour
First postoperative hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Principal Investigator: Enis Özkaya, Assoc. Prof., Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department

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

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31/2015

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.

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