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| ID | Type | Description | Link |
|---|---|---|---|
| 12-049 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Active Comparator | Group receives standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procare abdominal binder | Device |
| ||
| Standard of Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours from baseline |
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Inclusion Criteria:
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)
Able to read English and understand spoken English
Exclusion Criteria:
Onset of labor prior to time when the cesarean was scheduled
Complications during performance of cesarean or discovered during cesarean:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Kuhlmann, DO | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas School of Medicine-Wichita | Wichita | Kansas | 67214 | United States | ||
| Wesley Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32871021 | Derived | 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. |
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There were 66 women assessed for eligibility. Of those women, six were excluded from the trial before being assigned to groups. Of the six women excluded: three presented to the hospital in labor prior to the scheduled cesarean, two reported for treatment for chronic pain, and one woman wanted the intervention regardless of randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 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. Procare abdominal binder |
| FG001 | Control | Group receives standard of care Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 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. Procare abdominal binder |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Mean | Standard Deviation | g/dL | 24 hours from baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. Procare abdominal binder |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Itching | Non-systematic Assessment | Extended period of time wearing the abdominal binder resulted in itching. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zachary Kuhlmann, DO | University of Kansas School of Medicine - Wichita | 316-685-7234 | zkuhlmann@kumc.edu |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Wichita |
| Kansas |
| 67214 |
| United States |
| Excluded intraoperatively |
|
| Protocol Violation |
|
Group receives standard of care
Standard of Care
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous vaginal births | Median | Full Range | vaginal births |
|
| Previous cesarean deliveries | Median | Full Range | cesarean deliveries |
|
| Body mass index calculated during 1st visit | Mean | Standard Deviation | kg/m^2 |
|
| Gestational age at cesarean delivery | Mean | Standard Deviation | weeks |
|
| Infant birth weight | Mean | Standard Deviation | grams |
|
| Breech presentation | Number | participants |
|
| Received epidural | Number | participants |
|
| Received Duramorph | Number | participants |
|
| Number of pads used during 24 hours postoperative | Mean | Standard Deviation | pads used |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours postoperative |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours postoperative |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours postoperative |
|
|
|
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | Control | Group receives standard of care Standard of Care | 0 | 27 | 0 | 27 |
|
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |