N/A N=60 Randomized Treatment

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

Postpartum Hemorrhage · Pain

Bottom Line

View on ClinicalTrials.gov: NCT01786330 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Lowest Pain Level Postoperative — 1.66; 2.56 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Procare abdominal binder (Device); Standard of Care (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Zachary Kuhlmann, DO
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Lowest Pain Level Postoperative	1.66; 2.56	—
PRIMARY Average Pain Level Postoperative	3.45; 4.48	—
PRIMARY Worst Pain Level Postoperative	6.41; 6.67	—
SECONDARY Change in Hemoglobin Concentration	-1.84; -1.43	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01786330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.