The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

May 1, 2014 updated by: St. Luke's Hospital, Pennsylvania

The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial

To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion: All patients admitted to labor and delivery

Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.

Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

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

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St Luke's University Hospital
        • Contact:
        • Principal Investigator:
          • James N Anasti, MD

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women undergoing cesarean section for any indication

Exclusion Criteria:

  • unable to give consent

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: abdominal binder
Post cesarean section patients will get a abdominal binder placed
Device: abdominal Binder
placement of abdominal binder
No Intervention: No Abdominal Binder
Post cesarean section patients will not have abdominal binder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurement
Time Frame: up to post operateive day 2
Pain will be measured using a visual analog scale
up to post operateive day 2
Patient Distress score
Time Frame: up to post operateive day 2
A validated patient distress score will be used
up to post operateive day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
hemoglobin and hematocrit
Time Frame: post operative day 1 and 2
post operative day 1 and 2
Pain medication usage
Time Frame: post operative day 1 and 2
post operative day 1 and 2

Collaborators and Investigators

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

Sponsor

St. Luke's Hospital, Pennsylvania

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

November 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLHN-50-14

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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