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

Primary Purpose

Postpartum Hemorrhage, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procare abdominal binder
Standard of Care
Sponsored by
Zachary Kuhlmann, DO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Kansas School of Medicine-Wichita
  • Wesley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.

Group receives standard of care

Outcomes

Primary Outcome Measures

Lowest Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
Average Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Worst Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.

Secondary Outcome Measures

Change in Hemoglobin Concentration
Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.

Full Information

First Posted
February 5, 2013
Last Updated
March 10, 2016
Sponsor
Zachary Kuhlmann, DO
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1. Study Identification

Unique Protocol Identification Number
NCT01786330
Brief Title
Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
Official Title
Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zachary Kuhlmann, DO

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Group receives standard of care
Intervention Type
Device
Intervention Name(s)
Procare abdominal binder
Intervention Type
Other
Intervention Name(s)
Standard of Care
Primary Outcome Measure Information:
Title
Lowest Pain Level Postoperative
Description
SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
Time Frame
24 hours postoperative
Title
Average Pain Level Postoperative
Description
SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Time Frame
24 hours postoperative
Title
Worst Pain Level Postoperative
Description
SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Change in Hemoglobin Concentration
Description
Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.
Time Frame
24 hours from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: bleeding disorder or use of anticoagulants other than low-dose heparin abnormal placenta (placenta previa or accrete) Preoperative hemoglobin less than 10 mg/dL 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: placenta accreta, increta, or percreta vasa previa cesarean hysterectomy required for severe hemorrhage organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Kuhlmann, DO
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas School of Medicine-Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32871021
Citation
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Results Reference
derived

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

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