N/A
N=105
Post-partum Non-pharmacologic Pain Management
Pain Management · Vaginal Delivery
Bottom Line
View on ClinicalTrials.gov: NCT03903172 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Patient Reported Average Pain Score — 1.37; 1.06; 2.03; 2.41 units on a scale — p==0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abdominal binder (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wright State University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Average Pain Score |
1.37; 1.06; 2.03; 2.41 | =0.25 |
| PRIMARY Number of Patient Using Each Type of Non-narcotic Pain Medications |
30; 30; 1; 2; 1; 2 | =1.0 |
| PRIMARY Any Narcotic Pain Medication Use |
4; 2 | =1.0 |
Summary
This study aims to examine whether use of an abdominal binder for postpartum patients after vaginal delivery can effectively manage their pain and reduce the need for pharmacologic analgesics. The investigators hypothesize that use of an abdominal binder will decrease patient pain as reported on a visual analog scale of one to ten, and will decrease quantity of pain medications given. The study will be conducted at the Berry Women's Center at Miami Valley Hospital. Potential eligible participants will be approached regarding the study on admission to labor and delivery. The investigators will recruit 130 participants that will be randomized to two study arms, standard care and standard care plus abdominal binder with 65 participants in each study arm. Data will be collected prospectively while participants are admitted, and through review of electronic medical records. Potential benefits of this study include investigation of a cost-effective method for pain management that could improve patient comfort and reduce need for medications.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and older
- Pregnant
- Admitted to labor and delivery
- Anticipated spontaneous vaginal delivery
- Informed consent obtained
Exclusion Criteria
- Documented chronic pain condition
- Chronic narcotic use or Maternal Abstinence Treatment
- UDS positive for opiates on admission
- Trial of labor after cesarean
- Lack of sufficient English proficiency to obtain informed consent
Data sourced from ClinicalTrials.gov (NCT03903172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.