The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03306953
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 84.4

Study Details

Study Description

Brief Summary

This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: Rectus muscle approximation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain
• Actual Study Start Date: Oct 11, 2017
• Actual Primary Completion Date: Jan 15, 2018
• Actual Study Completion Date: Jan 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rectus muscle approximation Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.	Procedure: Rectus muscle approximation; The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
No Intervention: Control No approximation for the rectus muscle will be done for the control group in cesarean section.

Outcome Measures

Primary Outcome Measures

1. Early pain score [24 hours after cesarean section]

   Early pain score will be assessed by an investigator for patients

Secondary Outcome Measures

1. Late pain score [48 hours after cesarean section]

   Late pain score will be assessed by an investigator for patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo	Egypt	11956

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Eman F Omran, M.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Omran, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03306953
• Other Study ID Numbers: 5678
• First Posted: Oct 11, 2017
• Last Update Posted: Feb 5, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Feb 5, 2018