Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Pain Clinical Trial

Official title:

Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786330
• Other study ID #: 220121565
• Secondary ID: 12-049
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: June 18, 2014
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Cesarean section at term (at least 39 weeks gestation) scheduled in advance

• Singleton gestation confirmed by ultrasound in the current pregnancy

• Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)

• None of these pregnancy complications in the current pregnancy:

1. bleeding disorder or use of anticoagulants other than low-dose heparin

2. abnormal placenta (placenta previa or accrete)

3. Preoperative hemoglobin less than 10 mg/dL

4. Chorioamnionitis (intrauterine infection)

• No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)

• Able to read English and understand spoken English

Exclusion Criteria:

• Onset of labor prior to time when the cesarean was scheduled

• Complications during performance of cesarean or discovered during cesarean:

1. placenta accreta, increta, or percreta

2. vasa previa

3. cesarean hysterectomy required for severe hemorrhage

4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Postpartum Hemorrhage

Intervention

Device:
• Procare abdominal binder

Other:
• Standard of Care

Locations

Country	Name	City	State
United States	Kansas School of Medicine-Wichita	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Zachary Kuhlmann, DO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentration	Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values.	24 hours	No
Secondary	SF-MPQ2 Score	Pain assessment scale	24 hours	No