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Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

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ClinicalTrials.gov Identifier: NCT03470675
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Feyce M. Peralta, Northwestern University

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE June 27, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries. [ Time Frame: 1 week after vaginal delivery ]
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Perineal Pain [ Time Frame: Day 1 after delivery ]
    Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 1 week after delivery ]
    Perineal pain day 7 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 6 weeks after delivery ]
    Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 3 months after delivery ]
    Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 6 months after delivery ]
    Perineal pain 6 months after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
  • Perineal Pain [ Time Frame: 1 year after delivery ]
    Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
  • Presence of postpartum depression [ Time Frame: 1 week after delivery ]
    Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
  • Presence of postpartum depression [ Time Frame: 6 weeks after delivery ]
    Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
  • Assessment of maternal-infant bonding [ Time Frame: 1 week after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Assessment of maternal-infant bonding [ Time Frame: 6 weeks after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Assessment of maternal-infant bonding [ Time Frame: 3 months after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Medoc Pathway Device Score [ Time Frame: 1 week post delivery ]
    Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable
  • Maternal quality of life [ Time Frame: 3 months after delivery ]
    Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
  • Female sexual function [ Time Frame: 3 months after delivery ]
    Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function.
  • Promis 29 profile [ Time Frame: 6 week ]
    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good)
  • Promis 29 profile [ Time Frame: 3 month ]
    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 1 day after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 1 week after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 6 weeks after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 3 months after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief %. 0= no relief (poor) and 100% complete relief (good)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • Perineal Pain [ Time Frame: 1 day after delivery ]
    Perineal pain 1 day after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
  • Perineal Pain [ Time Frame: Day 1 after delivery ]
    Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: Day 2 after delivery ]
    Perineal pain day 2 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 6 weeks after delivery ]
    Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 3 months after delivery ]
    Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
  • Perineal Pain [ Time Frame: 1 year after delivery ]
    Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
  • Presence of postpartum depression [ Time Frame: 7 days after delivery ]
    Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
  • Presence of postpartum depression [ Time Frame: 6 weeks after delivery ]
    Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
  • Presence of postpartum depression [ Time Frame: 3 months after delivery ]
    Presence of postpartum depression 3 months after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
  • Assessment of maternal-infant bonding [ Time Frame: 7 days after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Assessment of maternal-infant bonding [ Time Frame: 6 weeks days after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Assessment of maternal-infant bonding [ Time Frame: 3 months after delivery ]
    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
  • Medoc Pathway Device Score [ Time Frame: 7 days post delivery ]
    Medoc Pathway Device (Durham NC) pain sensory results using VRS (verbal rating scale) 0 = no pain and 10 = worst pain imaginable
  • Maternal quality of life [ Time Frame: 3 months after delivery ]
    Patient Reported Outcome Measurement Information System (PROMIS) 29 questionnaire. 28 question survey
  • Female sexual function [ Time Frame: 3 months after delivery ]
    Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function and 36 high sexual function.
  • Promis 29 profile [ Time Frame: 6 week ]
    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good)
  • Promis 29 profile [ Time Frame: 3 month ]
    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 1 day after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 7 days after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 6 weeks after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief%. 0= no relief (poor) and 100% complete relief (good)
  • Brief Pain Inventory (Short Form) Modified [ Time Frame: 3 months after delivery ]
    7 question survey. 6 items scored 0 no pain -10 worst pain you can imagine scale. 1 item scored as relief %. 0= no relief (poor) and 100% complete relief (good)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Official Title  ICMJE Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
Brief Summary

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Postpartum Depression
Intervention  ICMJE
  • Drug: Epidural saline + IV saline
    Sterile saline injection in the epidural catheter and in the intravenous catheter
  • Drug: Epidural morphine 3 mg + IV saline
    Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
  • Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
    Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
Study Arms  ICMJE
  • Placebo Comparator: Epidural saline + IV saline
    Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
    Intervention: Drug: Epidural saline + IV saline
  • Active Comparator: Epidural morphine 3 mg + IV saline
    3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
    Intervention: Drug: Epidural morphine 3 mg + IV saline
  • Active Comparator: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
    3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
    Intervention: Drug: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18 years of age
  • English-speaking
  • Vaginal delivery (spontaneous or assisted)
  • A full-term fetus (>37 weeks' gestation)
  • OASIS as assessed by obstetrical provider
  • Functional epidural analgesia at time of delivery
  • Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion Criteria:

  • Previous pelvic surgery
  • History of chronic pelvic pain
  • History of recurrent urinary tract infections
  • Women with known malformations of their urinary tract
  • True allergies to ketamine and/or morphine
  • Preeclampsia or hypertensive disorder at the time of delivery
  • Obstructive sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Feyce M Peralta, MD 312-472-3585 feyce.peralta@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03470675
Other Study ID Numbers  ICMJE STU00206016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Feyce M. Peralta, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feyce Peralta, MD Northwestern University
PRS Account Northwestern University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP