Abdominal Binder Following Cesarean Delivery

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Device: Elastic abdominal binder

• Registration Number: NCT03080506
• Lead Sponsor: Chiang Mai University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-04-18
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Binder	Elastic abdominal binder	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand