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The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

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ClinicalTrials.gov Identifier: NCT02129894
Recruitment Status : Unknown
Verified April 2014 by St. Luke's Hospital, Pennsylvania.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
St. Luke's Hospital, Pennsylvania

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

Condition or disease Intervention/treatment Phase
Cesarean Section Post Operative Management Device: abdominal Binder Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial
Study Start Date : November 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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



Primary Outcome Measures :
  1. Pain measurement [ Time Frame: up to post operateive day 2 ]
    Pain will be measured using a visual analog scale

  2. Patient Distress score [ Time Frame: up to post operateive day 2 ]
    A validated patient distress score will be used


Secondary Outcome Measures :
  1. hemoglobin and hematocrit [ Time Frame: post operative day 1 and 2 ]
  2. Pain medication usage [ Time Frame: post operative day 1 and 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women undergoing cesarean section for any indication

Exclusion Criteria:

  • unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129894


Contacts
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Contact: James N Anasti, MD 484-526-4670 anastij@slhn.org

Locations
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United States, Pennsylvania
St Luke's University Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: James N Anasti, MD    484-526-4670    anastij@slhn.org   
Principal Investigator: James N Anasti, MD         
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT02129894     History of Changes
Other Study ID Numbers: SLHN-50-14
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by St. Luke's Hospital, Pennsylvania:
cesarean section
postoperative pain
pregnancy
abdominal binder