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

Zachary Kuhlmann, DO

Status: Completed

Conditions: Pain; Postpartum Hemorrhage

Treatments: Device: Procare abdominal binder; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01786330

12-049

220121565

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Device: Procare abdominal binder

Control

Active Comparator group

Description:

Group receives standard of care

Treatment:

Other: Standard of Care