Rectus Musle Reapproximation During Cesarean Section

January 7, 2024 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section

During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Study Type

Interventional

Enrollment (Actual)

300

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

  • Turkey
      • Istanbul, Turkey, 34303
        • Kanuni SSRTH

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-40 years old women undergoing cesarean section

Exclusion Criteria:

  • grandmultiparas

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: reappoximation of rectus muscle
During Cesarean Section rectus muscle will be reapproximated with interrupted sutures.
Procedure: Cesarean Section
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.
Active Comparator: no reappoximation of rectus muscle
During Cesarean Section rectus muscle will not be closed.
Procedure: Cesarean Section
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: Visual Analog Score
Time Frame: 24 hours after the procedure
Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score.
24 hours after the procedure
Postoperative interrectus distance
Time Frame: 6 weeks after the procedure
Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography
6 weeks after the procedure

Collaborators and Investigators

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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Berna Aslan A Çetin, KSSTRH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2018

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

October 6, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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