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

NCT01786330 | Completed Results

• 2 other identifiers: 22012156512-049
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Postpartum Hemorrhage; Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  24 hours postoperative

• 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.

  24 hours postoperative

• 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.

  24 hours postoperative

Secondary Outcomes (1)

• Change in Hemoglobin Concentration

  24 hours from baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Group receives standard of care

Other: Standard of Care

Interventions

Procare abdominal binder DEVICE

Intervention

Standard of Care OTHER

Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zachary Kuhlmann, DO: lead

Study Sites (2)

Kansas School of Medicine-Wichita

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Related Publications (1)

• 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.

  PMID: 32871021 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Zachary Kuhlmann, DO
• Organization: University of Kansas School of Medicine - Wichita

zkuhlmann@kumc.edu

316-685-7234

Study Officials

• Zachary Kuhlmann, DO

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

US (2)