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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786330
First Posted: February 7, 2013
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zachary Kuhlmann, DO, University of Kansas Medical Center Research Institute
  Purpose
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.

Condition Intervention
Postpartum Hemorrhage Pain Device: Procare abdominal binder Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Resource links provided by NLM:


Further study details as provided by Zachary Kuhlmann, DO, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Lowest Pain Level Postoperative [ Time Frame: 24 hours 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 [ Time Frame: 24 hours 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 [ Time Frame: 24 hours 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 [ Time Frame: 24 hours from baseline ]
    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.


Enrollment: 60
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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.
Device: Procare abdominal binder
Active Comparator: Control
Group receives standard of care
Other: Standard of Care

  Eligibility

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

    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)
  Contacts and Locations
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): NCT01786330


Locations
United States, Kansas
Kansas School of Medicine-Wichita
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Zachary Kuhlmann, DO
Investigators
Principal Investigator: Zachary Kuhlmann, DO University of Kansas Medical Center
  More Information

Responsible Party: Zachary Kuhlmann, DO, Principal Investigator, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01786330     History of Changes
Other Study ID Numbers: 220121565
12-049
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: February 9, 2016
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Hemorrhage
Pain, Postoperative
Postpartum Hemorrhage
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage