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

February 1, 2018 updated by: Eman Omran, Cairo University

The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

280

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

  • Egypt
    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early pain score
Time Frame: 24 hours after cesarean section
Early pain score will be assessed by an investigator for patients
24 hours after cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late pain score
Time Frame: 48 hours after cesarean section
Late pain score will be assessed by an investigator for patients
48 hours after cesarean section

Collaborators and Investigators

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

Sponsor

Cairo 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 (Actual)

October 11, 2017

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 20, 2018

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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