A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

March 14, 2016 updated by: Ragıp Atakan Al, Atatürk University

A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean

The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

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
      • Erzurum, Turkey, 25240
        • Atatürk Üniversitesi Araştırma Hastanesi

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • elective cesarean
  • previous cesarean (<4)
  • cesarean for distocia

Exclusion Criteria:

  • emergency cesarean ( fetal distress)
  • risk of obstetrical bleeding
  • maternal coagulation defects
  • adnexial mass
  • uterin myoma at incision site

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Extraperitoneal cesarean
Other: Extraperitoneal cesarean technique
Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
ACTIVE_COMPARATOR: Transperitoneal cesarean
Other: Transperitoneal cesarean technique
Pfannenstiel-Kerr technique for laparatomy and uterine entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skin-to-delivery time
Time Frame: 1 minute after delivery
1 minute after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 and 48 hour after cesarean
Pain will be measured by VAS
24 and 48 hour after cesarean
Operation time
Time Frame: Two minutes after surgery
skin-to-skin operation time
Two minutes after surgery
Hemoglobin differences
Time Frame: One hour before cesarean and 48 hours after cesarean
One hour before cesarean and 48 hours after cesarean
Need for analgesic
Time Frame: 24 and 48 hours after cesarean
All analgesic given after cesarean at hospital
24 and 48 hours after cesarean
Nausea
Time Frame: Two minutes and 48 hours after cesarean
Nausea during surgery and after surgery
Two minutes and 48 hours after cesarean
Vomiting
Time Frame: Two minutes and 48 hours after cesarean
Nausea during and after surgery
Two minutes and 48 hours after cesarean
Thoracic shoulder pain
Time Frame: 48 hours after cesarean
Thoracic shoulder pain after surgery
48 hours after cesarean
Urogenital distress measured by Urogenital Distress Inventory
Time Frame: One hour before cesarean and 24 hours after cesarean
One hour before cesarean and 24 hours after cesarean
Oral intake
Time Frame: 12 and 24 hours postoperatively
The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hours after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.
12 and 24 hours postoperatively
Anxiety during surgery
Time Frame: One minute after cesarean
Intense fear or anxiety during surgery without pain (yes or no)
One minute after cesarean
Pain during surgery
Time Frame: One minutes after surgery
Abdominal pain during surgery (yes or no)
One minutes after surgery

Collaborators and Investigators

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

Sponsor

Atatürk University

Investigators

  • Principal Investigator: Yunus E TOPDAGI, MD, Ataturk University
  • Study Director: Omer E Yapca, MD, Ataturk University

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

June 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77-2015

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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