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Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear (SuPPerP)

Primary Purpose

Perineal Tear, Perineal Laceration (Obstetric)

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Diclofenac Sodium 50Mg Suppository
Paracetamol 500Mg Suppository
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perineal Tear

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Stage 1:

a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery

Stage 2:

  1. All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016.
  2. All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery.
  3. All pregnant women who have consented to involve in the study.

Exclusion Criteria:

Stage 1:

  1. Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
  2. Patient who developed post-partum complications.

Stage 2:

  1. Patient who is allergic to paracetamol or voltaren.
  2. Patient who is unable to or unwilling to give consent.
  3. Patient who is ended up with caesarean section.
  4. Patient who sustained additional perineal tear including labial tear or periurethral tear.
  5. Patient who developed postpartum complications (eg. Retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Paracetamol

    Voltaren

    Arm Description

    Paracetamol 500Mg Suppository

    Diclofenac Sodium 50Mg Suppository

    Outcomes

    Primary Outcome Measures

    perineum pain score following childbirth

    Secondary Outcome Measures

    perineum pain score following childbirth
    perineum pain score following childbirth
    perineum pain score following childbirth
    perineum pain score following childbirth

    Full Information

    First Posted
    December 12, 2016
    Last Updated
    February 1, 2017
    Sponsor
    Clinical Research Centre, Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041779
    Brief Title
    Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear
    Acronym
    SuPPerP
    Official Title
    A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Research Centre, Malaysia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.
    Detailed Description
    Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perineal Tear, Perineal Laceration (Obstetric)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    909 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paracetamol
    Arm Type
    Active Comparator
    Arm Description
    Paracetamol 500Mg Suppository
    Arm Title
    Voltaren
    Arm Type
    Active Comparator
    Arm Description
    Diclofenac Sodium 50Mg Suppository
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac Sodium 50Mg Suppository
    Other Intervention Name(s)
    Voltaren 50Mg Suppository
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol 500Mg Suppository
    Other Intervention Name(s)
    Acetaminophen 500Mg Suppository
    Primary Outcome Measure Information:
    Title
    perineum pain score following childbirth
    Time Frame
    at 2nd to 3rd hour post repair
    Secondary Outcome Measure Information:
    Title
    perineum pain score following childbirth
    Time Frame
    immediate after delivery
    Title
    perineum pain score following childbirth
    Time Frame
    immediate post perineum repair
    Title
    perineum pain score following childbirth
    Time Frame
    at 5th to 6th hour post repair
    Title
    perineum pain score following childbirth
    Time Frame
    prior to discharge

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stage 1: a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery Stage 2: All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016. All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery. All pregnant women who have consented to involve in the study. Exclusion Criteria: Stage 1: Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth. Patient who developed post-partum complications. Stage 2: Patient who is allergic to paracetamol or voltaren. Patient who is unable to or unwilling to give consent. Patient who is ended up with caesarean section. Patient who sustained additional perineal tear including labial tear or periurethral tear. Patient who developed postpartum complications (eg. Retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shu Yuan Woon, MBBS
    Organizational Affiliation
    O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.
    Results Reference
    result
    PubMed Identifier
    10352050
    Citation
    Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999 Mar;26(1):11-7. doi: 10.1046/j.1523-536x.1999.00011.x.
    Results Reference
    result
    PubMed Identifier
    15507941
    Citation
    Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
    Results Reference
    result
    PubMed Identifier
    17196714
    Citation
    Williams A, Herron-Marx S, Carolyn H. The prevalence of enduring postnatal perineal morbidity and its relationship to perineal trauma. Midwifery. 2007 Dec;23(4):392-403. doi: 10.1016/j.midw.2005.12.006. Epub 2006 Dec 29.
    Results Reference
    result
    PubMed Identifier
    12917995
    Citation
    Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931.
    Results Reference
    result
    PubMed Identifier
    23440827
    Citation
    Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
    Results Reference
    result
    Citation
    Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.
    Results Reference
    result

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    Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear

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