Abdominal Binder Following Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080506
• Other study ID #: OBG-2559-04139
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 13, 2018
• Start date: April 18, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: March 2018
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Device:
• Elastic abdominal binder
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.

Locations

Country	Name	City	State
Thailand	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postoperative functional recovery	Six-minute walk test (6MWT)	In the morning of postoperative day 3
Secondary	Quality of life	The EuroQol Group's ED-5D-5L questionnaire	In the morning of postoperative day 3
Secondary	Postoperative complications	Febrile morbidity, wound complications, bowel ileus	In the morning, up to 7 days postoperation