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Post-partum Non-pharmacologic Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903172
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sheela Barhan, Wright State University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Management Vaginal Delivery Device: Abdominal binder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-blinded, parallel group
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Post-partum Non-pharmacologic Pain Management
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Binder Arm
Abdominal binder + standard of care postpartum pain management
Device: Abdominal binder
Abdominal binder

No Intervention: Standard of Care
Standard of care postpartum pain managment



Primary Outcome Measures :
  1. Patient reported average pain score [ Time Frame: Average score computed from Immediately postpartum, postpartum day 0, postpartum day 1 ]
    Pain score (standard scale is 1 - 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.

  2. Total non-narcotic pain medication use [ Time Frame: Total non-narcotic medication use from sum of postpartum day 0 and postpartum day 1 ]
    Total non-narcotic pain medication use recorded on MAR for postpartum day 0 and postpartum day 1

  3. Total narcotic pain medication use [ Time Frame: Total narcotic medication use from sum of postpartum day 0 and postpartum day 1 ]
    Total narcotic pain medication use (in morphine equivalents) as recorded on MAR for postpartum day 0 and postpartum day 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women will be enrolled
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903172


Locations
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United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Sponsors and Collaborators
Wright State University
Investigators
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Principal Investigator: Sheela Barhan, MD Wright State University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheela Barhan, Assistant Professor, Wright State University
ClinicalTrials.gov Identifier: NCT03903172    
Other Study ID Numbers: Barhan-Wysong-001
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shard on a case by case basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sheela Barhan, Wright State University:
pain management
vaginal delivery
nonpharmacologic
abdominal binder