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Clinical Trials/NCT01786330
NCT01786330
Completed
Not Applicable

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

Zachary Kuhlmann, DO2 sites in 1 country60 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Zachary Kuhlmann, DO
Enrollment
60
Locations
2
Primary Endpoint
Average Pain Level Postoperative
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Zachary Kuhlmann, DO
Responsible Party
Sponsor Investigator
Principal Investigator

Zachary Kuhlmann, DO

Principal Investigator

University of Kansas Medical Center

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)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change in Hemoglobin Concentration(24 hours from baseline)

Study Sites (2)

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