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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03903172
Other study ID # 06605
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date January 31, 2024

Study information

Verified date March 2024
Source Wright State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Abdominal binder
Abdominal binder

Locations

Country Name City State
United States Miami Valley Hospital Dayton Ohio

Sponsors (1)

Lead Sponsor Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Patient Reported Average Pain Score 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. Average score computed from postpartum day 0, postpartum day 1
Primary Number of Patient Using Each Type of Non-narcotic Pain Medications Number of patients using each type of non-narcotic pain medication as recorded on MAR for postpartum day 0 and postpartum day 1 Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1
Primary Any Narcotic Pain Medication Use Any narcotic pain medication use (yes/no) as recorded on MAR for postpartum day 0 and postpartum day 1 Any narcotic medication use from postpartum day 0 and postpartum day 1
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