Abdominal Binder Following Cesarean Delivery

Study Overview
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Brief Summary
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Cesarean delivery is a common obstetrical procedure and is associated with increased maternal morbidity and mortality. Pain and limited mobilization are major contributing factors that result in delayed functional recovery and complications. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not been properly examined. The aim of this study is to examine the effect of postcesarean elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to support incisional site.

Official Title
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Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Cesarean Delivery: a Randomized Controlled Trial

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Device: Elastic abdominal binder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women undergoing cesarean delivery Exclusion Criteria: Cesarean hysterectomy Intraoperative accidental injury to urinary or gastrointestinal organs Postoperative admission to intensive care unit (ICU) Postoperative intraperitoneal drain placement Unable to understand and follow oral/written instructions Severe neuromuscular or circulatory disorders Pulmonary diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binder<br>Each woman will be fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder will be placed snuggly tight on top of the hospital gown at the infraumbilical level with the incision positioned at the middle part of the binder. The patients will be encouraged to wear binders at all time. However, periods of break from wearing the binder will be allowed at their convenience. | Device: Elastic abdominal binder<br>* Participants will be fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder will be placed snuggly tight on top of the hospital gown at the infraumbilical level with the incision positioned at the middle part of the binder. The patients will be encouraged to wear binders at all time. However, periods of break from wearing the binder will be allowed at their convenience.<br>|
| No Intervention: No binder<br>The women will not be given a chance to wear abdominal binder or the likes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily average postoperative pain scores | A visual analog scale pain score | An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation | 
| Postoperative functional recovery | Six-minute walk test (6MWT) | In the morning of postoperative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The EuroQol Group's ED-5D-5L questionnaire | In the morning of postoperative day 3 | 
| Postoperative complications | Febrile morbidity, wound complications, bowel ileus | In the morning, up to 7 days postoperation |