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OpenTrials
Completed

NCT Number: NCT03080506

Abdominal Binder Following Cesarean Delivery

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastic abdominal binder

Device

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.

Primary outcomes

  1. Daily average postoperative pain scores

    Time frame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation

    A visual analog scale pain score

  2. Postoperative functional recovery

    Time frame: In the morning of postoperative day 3

    Six-minute walk test (6MWT)

Secondary outcomes

  1. Quality of life

    Time frame: In the morning of postoperative day 3

    The EuroQol Group's ED-5D-5L questionnaire

  2. Postoperative complications

    Time frame: In the morning, up to 7 days postoperation

    Febrile morbidity, wound complications, bowel ileus

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2017
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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