Back to resultsA Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transperitoneal cesarean technique
Extraperitoneal cesarean technique
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Extra-peritoneal cesarean, Intra-peritoneal cesarean
Eligibility Criteria
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
Sites / Locations
- Atatürk Üniversitesi Araştırma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Extraperitoneal cesarean
Transperitoneal cesarean
Arm Description
Outcomes
Primary Outcome Measures
Skin-to-delivery time
Secondary Outcome Measures
Postoperative pain
Pain will be measured by VAS
Operation time
skin-to-skin operation time
Hemoglobin differences
Need for analgesic
All analgesic given after cesarean at hospital
Nausea
Nausea during surgery and after surgery
Vomiting
Nausea during and after surgery
Thoracic shoulder pain
Thoracic shoulder pain after surgery
Urogenital distress measured by Urogenital Distress Inventory
Oral intake
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.
Anxiety during surgery
Intense fear or anxiety during surgery without pain (yes or no)
Pain during surgery
Abdominal pain during surgery (yes or no)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02479932
Brief Title
A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
Official Title
A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Extra-peritoneal cesarean, Intra-peritoneal cesarean
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extraperitoneal cesarean
Arm Type
Active Comparator
Arm Title
Transperitoneal cesarean
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Transperitoneal cesarean technique
Intervention Description
Pfannenstiel-Kerr technique for laparatomy and uterine entry
Intervention Type
Other
Intervention Name(s)
Extraperitoneal cesarean technique
Intervention Description
Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
Primary Outcome Measure Information:
Title
Skin-to-delivery time
Time Frame
1 minute after delivery
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Pain will be measured by VAS
Time Frame
24 and 48 hour after cesarean
Title
Operation time
Description
skin-to-skin operation time
Time Frame
Two minutes after surgery
Title
Hemoglobin differences
Time Frame
One hour before cesarean and 48 hours after cesarean
Title
Need for analgesic
Description
All analgesic given after cesarean at hospital
Time Frame
24 and 48 hours after cesarean
Title
Nausea
Description
Nausea during surgery and after surgery
Time Frame
Two minutes and 48 hours after cesarean
Title
Vomiting
Description
Nausea during and after surgery
Time Frame
Two minutes and 48 hours after cesarean
Title
Thoracic shoulder pain
Description
Thoracic shoulder pain after surgery
Time Frame
48 hours after cesarean
Title
Urogenital distress measured by Urogenital Distress Inventory
Time Frame
One hour before cesarean and 24 hours after cesarean
Title
Oral intake
Description
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.
Time Frame
12 and 24 hours postoperatively
Title
Anxiety during surgery
Description
Intense fear or anxiety during surgery without pain (yes or no)
Time Frame
One minute after cesarean
Title
Pain during surgery
Description
Abdominal pain during surgery (yes or no)
Time Frame
One minutes after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunus E TOPDAGI, MD
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omer E Yapca, MD
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Atatürk Üniversitesi Araştırma Hastanesi
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
12. IPD Sharing Statement
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A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
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