Postpartum HemorrhageNCT01786330
Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
A study testing Procare abdominal binder in people with Postpartum Hemorrhage and Pain, run by Zachary Kuhlmann, DO at 2 sites in United States.
Trial summary
This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Pain
- What is being tested?
- Procare abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cesarean section at term (at least 39 weeks gestation) scheduled in advance
- Singleton gestation confirmed by ultrasound in the current pregnancy
- Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
- None of these pregnancy complications in the current pregnancy:
- bleeding disorder or use of anticoagulants other than low-dose heparin
- abnormal placenta (placenta previa or accrete)
Show all 10Show fewer
- Preoperative hemoglobin less than 10 mg/dL
- Chorioamnionitis (intrauterine infection)
- No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
- Able to read English and understand spoken English
Who cannot join
- Onset of labor prior to time when the cesarean was scheduled
- Complications during performance of cesarean or discovered during cesarean:
- placenta accreta, increta, or percreta
- vasa previa
- cesarean hysterectomy required for severe hemorrhage
- organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas School of Medicine-Wichita
Wichita, Kansas, 67214
Wesley Medical Center
Wichita, Kansas, 67214
About this study
This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.
- Conditions
- Postpartum Hemorrhage, Pain
- Being tested
- Procare abdominal binder, Standard of Care
- Medical subject headings
- Postpartum Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procare abdominal binderDevice
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Receives: Device: Procare abdominal binder |
| Control | Active comparator | Group receives standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
Measured: 24 hours postoperative
Average Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Measured: 24 hours postoperative
Worst Pain Level Postoperative
SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.
Measured: 24 hours postoperative
Secondary outcomes (1)
Change in Hemoglobin Concentration
Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.
Measured: 24 hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zachary Kuhlmann, DO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zachary Kuhlmann, DO, University of Kansas Medical Center
- Investigators
- Zachary Kuhlmann, DO, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786330
- Sponsor's protocol ID
- 220121565
- Other IDs
- 12-049
- Status last verified
- Mar 2016
- First submitted
- 5 Feb 2013
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- 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 32871021
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
- ClinicalTrials.gov ID
- NCT01786330
- Acronym / sponsor ID
- 220121565
- Conditions
- Postpartum Hemorrhage, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zachary Kuhlmann, DOUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Procare abdominal binderGroup receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. |
| Control | Active comparator | Other: Standard of CareGroup receives standard of care |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Cesarean section at term (at least 39 weeks gestation) scheduled in advance
- Singleton gestation confirmed by ultrasound in the current pregnancy
- Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
- None of these pregnancy complications in the current pregnancy:
- No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
Key exclusion criteria (6 listed)
- Onset of labor prior to time when the cesarean was scheduled
- Complications during performance of cesarean or discovered during cesarean:
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 |
|---|---|---|
| Procare abdominal binder | Device | Intervention |
| Standard of Care | Other | Control |
Primary outcome
Lowest Pain Level Postoperative
Time frame: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
Average Pain Level Postoperative
Time frame: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Worst Pain Level Postoperative
Time frame: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.
1 secondary outcome
Change in Hemoglobin Concentration
Time frame: 24 hours from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Zachary Kuhlmann, DO principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procare abdominal binder in people with Postpartum Hemorrhage and Pain, run by Zachary Kuhlmann, DO at 2 sites 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 10 inclusion and 6 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lowest Pain Level Postoperative (time frame: 24 hours postoperative). The study lists 3 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 NCT01786330, 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 11 Apr 2016; AzTrials last refreshed its copy on 26 Oct 2026.