The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery

August 19, 2024 updated by: Esraa Saad Abdellattif, Sohag University

The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery :a Prospective Comparative Study

The effect of abdominal binders on patient's wellbeing after cesarean delivery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The effect of abdominal binders on patient's wellbeing after cesarean delivery 12 hours and one week after cesarean section

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Contact Backup

  • Name: abdou s aitallah, professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

any female post cesarean section of singleton 34 wks gestaion fetus with previous cs

Exclusion Criteria:

primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group Study group(Group1)
25 participant will be in study group (abdominal binders)
Device: abdominal binder
study group will be abdominal binders and control group will be control group , 12 hrs and one week later VAS and QOR 40 will assess patient,s wellbeing
Placebo Comparator: Control group (Group 2)
25 participants will be in control group
Device: abdominal binder
study group will be abdominal binders and control group will be control group , 12 hrs and one week later VAS and QOR 40 will assess patient,s wellbeing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of abdominal binders on pain after cesarean section
Time Frame: 6 months
abdominal binders will be fit on patient abdomin 2 hrs post cs and VAS will be assessed 12 hrs post cesarean section
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of abdominal binders on patient's wellbeing after cesarean delivery
Time Frame: one week postoperatively
effect after one week on quality of recovery ( infection, hematoma, seroma) by QOR 40
one week postoperatively

Collaborators and Investigators

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

Sponsor

Sohag University

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)

July 15, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-24-07-20MS

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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