Back to resultsThe Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rectus muscle approximation
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Women who will undergo first elective cesarean section
- Singleton pregnancy
Exclusion Criteria:
- Previous abdominal or pelvic surgery
- Medical or psychiatric disease
- Previous pelvic inflammatory disease
- Obesity
- Allergy to analgesics
Sites / Locations
- Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Rectus muscle approximation
Control
Arm Description
Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.
No approximation for the rectus muscle will be done for the control group in cesarean section.
Outcomes
Primary Outcome Measures
Early pain score
Early pain score will be assessed by an investigator for patients
Secondary Outcome Measures
Late pain score
Late pain score will be assessed by an investigator for patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03306953
Brief Title
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
Official Title
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.
Detailed Description
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rectus muscle approximation
Arm Type
Active Comparator
Arm Description
Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No approximation for the rectus muscle will be done for the control group in cesarean section.
Intervention Type
Procedure
Intervention Name(s)
Rectus muscle approximation
Intervention Description
The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
Primary Outcome Measure Information:
Title
Early pain score
Description
Early pain score will be assessed by an investigator for patients
Time Frame
24 hours after cesarean section
Secondary Outcome Measure Information:
Title
Late pain score
Description
Late pain score will be assessed by an investigator for patients
Time Frame
48 hours after cesarean section
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who will undergo first elective cesarean section
Singleton pregnancy
Exclusion Criteria:
Previous abdominal or pelvic surgery
Medical or psychiatric disease
Previous pelvic inflammatory disease
Obesity
Allergy to analgesics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman F Omran, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
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