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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Hemorrhage, Pain

Intervention / Treatment
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* Device: Procare abdominal binder
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br> <br> |
| Active Comparator: Control<br>Group receives standard of care | Other: Standard of Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Concentration | Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively. | 24 hours from baseline |