The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

Cesarean Section Post Operative Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02129894
• Other study ID #: SLHN-50-14
• Status: Unknown status
• Phase: Phase 3
• First received: April 30, 2014
• Last updated: May 1, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2014
• Source: St. Luke's Hospital, Pennsylvania
• Contact: James N Anasti, MD
• Phone: 484-526-4670
• Email: anastij[@]slhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 210
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Women undergoing cesarean section for any indication

Exclusion Criteria:

• unable to give consent

Related Conditions & MeSH terms

• Cesarean Section Post Operative Management

Intervention

Device:
• abdominal Binder
placement of abdominal binder

Locations

Country	Name	City	State
United States	St Luke's University Hospital	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement	Pain will be measured using a visual analog scale	up to post operateive day 2
Primary	Patient Distress score	A validated patient distress score will be used	up to post operateive day 2
Secondary	hemoglobin and hematocrit		post operative day 1 and 2
Secondary	Pain medication usage		post operative day 1 and 2