Post-partum Non-pharmacologic Pain Management

NCT03903172 | Completed Results FDA Device

• 1 other identifier: 06605
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Vaginal Delivery

Keywords

pain management; vaginal delivery; nonpharmacologic; abdominal binder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Binder Arm

EXPERIMENTAL

Abdominal binder + standard of care postpartum pain management

Device: Abdominal binder

Standard of Care

NO INTERVENTION

Standard of care postpartum pain managment

Interventions

Abdominal binder DEVICE

Abdominal binder

Binder Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women will be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age and older
• Pregnant
• Admitted to labor and delivery
• Anticipated spontaneous vaginal delivery
• Informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Related Publications (8)

• Eshkevari L, Trout KK, Damore J. Management of postpartum pain. J Midwifery Womens Health. 2013 Nov-Dec;58(6):622-31. doi: 10.1111/jmwh.12129.

  PMID: 24406035 BACKGROUND

• Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27.

  PMID: 15338362 BACKGROUND

• Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26.

  PMID: 19863747 BACKGROUND

• Mens JM, Damen L, Snijders CJ, Stam HJ. The mechanical effect of a pelvic belt in patients with pregnancy-related pelvic pain. Clin Biomech (Bristol). 2006 Feb;21(2):122-7. doi: 10.1016/j.clinbiomech.2005.08.016. Epub 2005 Oct 7.

  PMID: 16214275 BACKGROUND

• Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015 Sep 30;2015(9):CD001139. doi: 10.1002/14651858.CD001139.pub4.

  PMID: 26422811 BACKGROUND

• Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.

  PMID: 26892694 BACKGROUND

• Ghana S, Hakimi S, Mirghafourvand M, Abbasalizadeh F, Behnampour N. Randomized controlled trial of abdominal binders for postoperative pain, distress, and blood loss after cesarean delivery. Int J Gynaecol Obstet. 2017 Jun;137(3):271-276. doi: 10.1002/ijgo.12134. Epub 2017 Mar 28.

  PMID: 28241386 BACKGROUND

• Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.

  PMID: 33078388 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

While the initial sample size estimate indicated a requirement of 64 patients per group, the effect size was much smaller than anticipated, limiting the overall study power and the ability to detect a difference. This study was unblinded for the medical team and patients. It was not possible to determine the total length of time patients were wearing the abdominal binders. Binders were applied within the first two hours postpartum, and documented in the EMR, removal was not always documented.

Results Point of Contact

• Title: Sheela Barhan, MD
• Organization: Wright State University

sheela.barhan@wright.edu

937-208-2850

Study Officials

• Sheela Barhan, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded, parallel group

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 4, 2019
• Study Start: June 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: January 31, 2024
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)