Cesarean Section Post Operative ManagementPhase 3NCT02129894
The Use of Abdominal Binders in Patients Undergoing Cesarean Sections
A Phase 3 study testing abdominal Binder in people with Cesarean Section Post Operative Management, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
To see if the use of Abdominal Binders improves patients out comes after cesarean delivery Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section Post Operative Management
- What is being tested?
- abdominal Binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing cesarean section for any indication
Who cannot join
- unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Luke's University Hospital
Bethlehem, Pennsylvania, 18015
James N Anasti, MD, 484-526-4670, anastij@slhn.org
James N Anasti, MD
About this study
Official title: The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial
To see if the use of Abdominal Binders improves patients out comes after cesarean delivery
Read the detailed description
Inclusion: All patients admitted to labor and delivery
Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.
Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.
- Being tested
- abdominal Binder
- Keywords
- cesarean section, postoperative pain, pregnancy, abdominal binder
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal BinderDevice
placement of abdominal binder
| Study group | Role | What they receive |
|---|---|---|
| abdominal binder | Active comparator | Post cesarean section patients will get a abdominal binder placed Receives: Device: abdominal Binder |
| No Abdominal Binder | No intervention | Post cesarean section patients will not have abdominal binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement
Pain will be measured using a visual analog scale
Measured: up to post operateive day 2
Patient Distress score
A validated patient distress score will be used
Measured: up to post operateive day 2
Secondary outcomes (2)
hemoglobin and hematocrit
Measured: post operative day 1 and 2
Pain medication usage
Measured: post operative day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section Post Operative ManagementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129894
- Sponsor's protocol ID
- SLHN-50-14
- Status last verified
- Apr 2014
- First submitted
- 30 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
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 32871021Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.
PubMed 26892694
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02129894
- Acronym / sponsor ID
- SLHN-50-14
- Keywords
- cesarean section, postoperative pain, pregnancy, abdominal binder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 2 May 2014 (estimated)
- 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.
To see if the use of Abdominal Binders improves patients out comes after cesarean delivery
Detailed description
Inclusion: All patients admitted to labor and delivery
Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.
Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abdominal binder | Active comparator | Device: abdominal BinderPost cesarean section patients will get a abdominal binder placed |
| No Abdominal Binder | No intervention | –Post cesarean section patients will not have abdominal binder |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing cesarean section for any indication
Key exclusion criteria (1 listed)
- unable to give consent
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 |
|---|---|---|
| abdominal Binderplacement of abdominal binder | Device | abdominal binder |
Primary outcome
Pain measurement
Time frame: up to post operateive day 2
Pain will be measured using a visual analog scale
Patient Distress score
Time frame: up to post operateive day 2
A validated patient distress score will be used
2 secondary outcomes
hemoglobin and hematocrit
Time frame: post operative day 1 and 2
Pain medication usage
Time frame: post operative day 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- 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.
- Derived from this study: PubMed 26892694Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abdominal Binder in people with Cesarean Section Post Operative Management, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 2 May 2014. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James N Anasti, MD (484-526-4670, anastij@slhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurement (time frame: up to post operateive day 2). 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 NCT02129894, which also lists 2 linked publications.
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 2 May 2014.