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

NCT ID: NCT01786330

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Procare abdominal binder

Intervention Type: DEVICE

Control

Group receives standard of care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Interventions

Procare abdominal binder

Intervention Type: DEVICE

Standard of Care

Intervention Type: OTHER

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:

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zachary Kuhlmann, DO

OTHER

Sponsor Role: lead

Responsible Party

Zachary Kuhlmann, DO

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zachary Kuhlmann, DO

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Kansas School of Medicine-Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32871021 (View on PubMed)

Other Identifiers

12-049

Identifier Type: -

Identifier Source: secondary_id

220121565

Identifier Type: -

Identifier Source: org_study_id