Trial Outcomes & Findings for Post-partum Non-pharmacologic Pain Management (NCT NCT03903172)

NCT ID: NCT03903172

Last Updated: 2024-04-23

Results Overview

Pain score (standard scale is 0 - no pain to 10- severe pain) will be recorded by nursing staff in electronic medical record per standard of care. Average pain score for postpartum day 0 and postpartum day 1 will be computed. High scores represent greater pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 105 participants
• Primary outcome timeframe: Average score computed from postpartum day 0, postpartum day 1
• Results posted on: 2024-04-23

Participant Flow

Participant milestones

Measure	Binder Arm Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care Standard of care postpartum pain managment
Overall Study STARTED	54	51
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Binder Arm Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care Standard of care postpartum pain managment
Overall Study screen fail	4	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Binder Arm n=50 Participants Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care n=50 Participants Standard of care postpartum pain managment	Total n=100 Participants Total of all reporting groups
Age, Continuous	26.4 years STANDARD_DEVIATION 6.0 • n=50 Participants	23.2 years STANDARD_DEVIATION 3.9 • n=50 Participants	24.8 years STANDARD_DEVIATION 5.3 • n=100 Participants
Sex: Female, Male Female	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants
Postpartum pain score (standard scale is 0 - no pain to 10- severe pain)	0.68 units on a scale STANDARD_DEVIATION 1.68 • n=50 Participants	0.16 units on a scale STANDARD_DEVIATION 0.65 • n=50 Participants	0.42 units on a scale STANDARD_DEVIATION 1.3 • n=100 Participants

PRIMARY outcome

Timeframe: Average score computed from postpartum day 0, postpartum day 1

Pain score (standard scale is 0 - no pain to 10- severe pain) will be recorded by nursing staff in electronic medical record per standard of care. Average pain score for postpartum day 0 and postpartum day 1 will be computed. High scores represent greater pain.

Outcome measures

Measure	Binder Arm n=50 Participants Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care n=50 Participants Standard of care postpartum pain managment
Patient Reported Average Pain Score Average pain on postpartum Day 1	2.03 units on a scale Standard Deviation 1.6	2.41 units on a scale Standard Deviation 1.3
Patient Reported Average Pain Score Average pain on postpartum Day 0	1.37 units on a scale Standard Deviation 1.35	1.06 units on a scale Standard Deviation 1.60

PRIMARY outcome

Timeframe: Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1

Number of patients using each type of non-narcotic pain medication as recorded on MAR for postpartum day 0 and postpartum day 1

Outcome measures

Measure	Binder Arm n=50 Participants Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care n=50 Participants Standard of care postpartum pain managment
Number of Patient Using Each Type of Non-narcotic Pain Medications Acetaminophen	30 Participants	30 Participants
Number of Patient Using Each Type of Non-narcotic Pain Medications Ibuprofen	1 Participants	2 Participants
Number of Patient Using Each Type of Non-narcotic Pain Medications Cyclobenzaprine	1 Participants	2 Participants
Number of Patient Using Each Type of Non-narcotic Pain Medications Methocarbamol	1 Participants	6 Participants
Number of Patient Using Each Type of Non-narcotic Pain Medications Hydroxyzine	0 Participants	2 Participants
Number of Patient Using Each Type of Non-narcotic Pain Medications Other	6 Participants	5 Participants

PRIMARY outcome

Timeframe: Any narcotic medication use from postpartum day 0 and postpartum day 1

Any narcotic pain medication use (yes/no) as recorded on MAR for postpartum day 0 and postpartum day 1

Outcome measures

Measure	Binder Arm n=50 Participants Abdominal binder + standard of care postpartum pain management Abdominal binder: Abdominal binder	Standard of Care n=50 Participants Standard of care postpartum pain managment
Any Narcotic Pain Medication Use	4 Participants	2 Participants

Adverse Events

Binder Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheela Barhan, MD

Wright State University

Phone: 937-208-2850

Email: sheela.barhan@wright.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place