Cesarean Section ComplicationsNCT03080506
Abdominal Binder Following Cesarean Delivery
A study testing Elastic abdominal binder in people with Cesarean Section Complications, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Elastic abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- 18 Apr 2017to 12 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women undergoing cesarean delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Cesarean Delivery: a Randomized Controlled Trial
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.
- Conditions
- Cesarean Section Complications
- Being tested
- Elastic abdominal binder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Elastic abdominal binder |
| No binder | No intervention | The women will not be given a chance to wear abdominal binder or the likes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily average postoperative pain scores
A visual analog scale pain score
Measured: 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)
Measured: In the morning of postoperative day 3
Secondary outcomes (2)
Quality of life
The EuroQol Group's ED-5D-5L questionnaire
Measured: In the morning of postoperative day 3
Postoperative complications
Febrile morbidity, wound complications, bowel ileus
Measured: In the morning, up to 7 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start18 Apr 2017
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, MSc, Study chair, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080506
- Sponsor's protocol ID
- OBG-2559-04139
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Cesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03080506
- Acronym / sponsor ID
- OBG-2559-04139
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binder | Experimental | Device: Elastic abdominal binderEach 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. |
| No binder | No intervention | –The women will not be given a chance to wear abdominal binder or the likes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women undergoing cesarean delivery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic abdominal binderParticipants 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 | Binder |
Primary outcome
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
Postoperative functional recovery
Time frame: In the morning of postoperative day 3
Six-minute walk test (6MWT)
2 secondary outcomes
Quality of life
Time frame: In the morning of postoperative day 3
Postoperative complications
Time frame: In the morning, up to 7 days postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 32871021Zimpel 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kittipat Charoenkwan, MD, MSc study chair
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic abdominal binder in people with Cesarean Section Complications, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.