A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479932
• Other study ID #: 77-2015
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: March 14, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health: Turkey
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• Transperitoneal cesarean technique
Pfannenstiel-Kerr technique for laparatomy and uterine entry
• Extraperitoneal cesarean technique
Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

Locations

Country	Name	City	State
Turkey	Atatürk Üniversitesi Arastirma Hastanesi	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin-to-delivery time		1 minute after delivery	No
Secondary	Postoperative pain	Pain will be measured by VAS	24 and 48 hour after cesarean	No
Secondary	Operation time	skin-to-skin operation time	Two minutes after surgery	No
Secondary	Hemoglobin differences		One hour before cesarean and 48 hours after cesarean	No
Secondary	Need for analgesic	All analgesic given after cesarean at hospital	24 and 48 hours after cesarean	No
Secondary	Nausea	Nausea during surgery and after surgery	Two minutes and 48 hours after cesarean	No
Secondary	Vomiting	Nausea during and after surgery	Two minutes and 48 hours after cesarean	No
Secondary	Thoracic shoulder pain	Thoracic shoulder pain after surgery	48 hours after cesarean	No
Secondary	Urogenital distress measured by Urogenital Distress Inventory		One hour before cesarean and 24 hours after cesarean	No
Secondary	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.	12 and 24 hours postoperatively	No
Secondary	Anxiety during surgery	Intense fear or anxiety during surgery without pain (yes or no)	One minute after cesarean	No
Secondary	Pain during surgery	Abdominal pain during surgery (yes or no)	One minutes after surgery	No