NCT03080506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 7, 2017

Last Update Submit

March 13, 2018

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Quality of life

    In the morning of postoperative day 3

  • Postoperative complications

    In the morning, up to 7 days postoperation

Study Arms (2)

Binder

EXPERIMENTAL

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

No binder

NO INTERVENTION

The women will not be given a chance to wear abdominal binder or the likes.

Interventions

Elastic abdominal binderDEVICE

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.

Binder

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women undergoing cesarean delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

    PMID: 32871021DERIVED

Study Officials

  • Kittipat Charoenkwan, MD, MSc

    Chiang Mai University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 15, 2017

Study Start

April 18, 2017

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

TH(1)