Pain, Postpartum Hemorrhage
Conditions
Brief 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. 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.
Interventions
OTHERStandard of Care
DEVICEProcare abdominal binder
Sponsors
Zachary Kuhlmann, DO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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: 1. bleeding disorder or use of anticoagulants other than low-dose heparin 2. abnormal placenta (placenta previa or accrete) 3. Preoperative hemoglobin less than 10 mg/dL 4. 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
Exclusion criteria
* Onset of labor prior to time when the cesarean was scheduled * Complications during performance of cesarean or discovered during cesarean: 1. placenta accreta, increta, or percreta 2. vasa previa 3. cesarean hysterectomy required for severe hemorrhage 4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest Pain Level Postoperative | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Concentration | 24 hours from baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| Control Group receives standard of care
Standard of Care | 27 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded intraoperatively | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 4.7 | 27.7 years STANDARD_DEVIATION 4.4 | 28.1 years STANDARD_DEVIATION 4.6 |
| Body mass index calculated during 1st visit | 28.9 kg/m^2 STANDARD_DEVIATION 6.6 | 28.6 kg/m^2 STANDARD_DEVIATION 6.3 | 28.7 kg/m^2 STANDARD_DEVIATION 6.4 |
| Breech presentation | 3 participants | 3 participants | 6 participants |
| Gestational age at cesarean delivery | 39.1 weeks STANDARD_DEVIATION 0.3 | 39.3 weeks STANDARD_DEVIATION 0.6 | 39.2 weeks STANDARD_DEVIATION 0.5 |
| Infant birth weight | 3632.5 grams STANDARD_DEVIATION 449.2 | 3525.2 grams STANDARD_DEVIATION 514.8 | 3580.8 grams STANDARD_DEVIATION 480.6 |
| Number of pads used during 24 hours postoperative | 5.29 pads used STANDARD_DEVIATION 2.27 | 5.48 pads used STANDARD_DEVIATION 1.95 | 5.38 pads used STANDARD_DEVIATION 2.1 |
| Previous cesarean deliveries | 1 cesarean deliveries | 1 cesarean deliveries | 1 cesarean deliveries |
| Previous vaginal births | 0 vaginal births | 0 vaginal births | 0 vaginal births |
| Received Duramorph | 29 participants | 27 participants | 56 participants |
| Received epidural | 28 participants | 27 participants | 55 participants |
| Region of Enrollment United States | 29 participants | 27 participants | 56 participants |
| Sex: Female, Male Female | 29 Participants | 27 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 29 | 0 / 27 |
| serious Total, serious adverse events | 0 / 29 | 0 / 27 |
Outcome results
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.
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Average Pain Level Postoperative | 3.45 units on a scale | Standard Deviation 1.74 |
| Control | Average Pain Level Postoperative | 4.48 units on a scale | Standard Deviation 1.6 |
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.
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Lowest Pain Level Postoperative | 1.66 units on a scale | Standard Deviation 1.47 |
| Control | Lowest Pain Level Postoperative | 2.56 units on a scale | Standard Deviation 1.22 |
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.
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Worst Pain Level Postoperative | 6.41 units on a scale | Standard Deviation 2.47 |
| Control | Worst Pain Level Postoperative | 6.67 units on a scale | Standard Deviation 1.8 |
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.
Time frame: 24 hours from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Hemoglobin Concentration | -1.84 g/dL | Standard Deviation 1.33 |
| Control | Change in Hemoglobin Concentration | -1.43 g/dL | Standard Deviation 0.61 |