<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041779</url>
  </required_header>
  <id_info>
    <org_study_id>NMRR-15-868-26140</org_study_id>
    <nct_id>NCT03041779</nct_id>
  </id_info>
  <brief_title>Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear</brief_title>
  <acronym>SuPPerP</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Research Centre, Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Research Centre, Malaysia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the prevalence of pain score for perineum pain following childbirth followed by&#xD;
      phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal&#xD;
      suppository in postpartum perineum pain secondary to perineal trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal&#xD;
      suppositories are associated with less pain up to 24 hours after birth, and less additional&#xD;
      analgesia is required. Therefore, In view of rectal route of analgesic administration is&#xD;
      better in local action and systemic paracetamol also proven to be effective in controlling&#xD;
      post-partum perineal pain with unknown effectiveness in its suppository form; the&#xD;
      investigators would like to conduct this study to investigate the effectiveness of&#xD;
      acetaminophen rectal suppository versus diclofenac rectal suppository in controlling&#xD;
      postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months&#xD;
      prospective observational study which aims to determine the prevalence and severity of&#xD;
      perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is&#xD;
      a single blinded, open-labelled, randomized control trial study design which will determine&#xD;
      if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in&#xD;
      reducing postpartum perineal pain secondary to perineal trauma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>perineum pain score following childbirth</measure>
    <time_frame>at 2nd to 3rd hour post repair</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>perineum pain score following childbirth</measure>
    <time_frame>immediate after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perineum pain score following childbirth</measure>
    <time_frame>immediate post perineum repair</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perineum pain score following childbirth</measure>
    <time_frame>at 5th to 6th hour post repair</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perineum pain score following childbirth</measure>
    <time_frame>prior to discharge</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">909</enrollment>
  <condition>Perineal Tear</condition>
  <condition>Perineal Laceration (Obstetric)</condition>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paracetamol 500Mg Suppository</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voltaren</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diclofenac Sodium 50Mg Suppository</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium 50Mg Suppository</intervention_name>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>Voltaren 50Mg Suppository</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol 500Mg Suppository</intervention_name>
    <arm_group_label>Voltaren</arm_group_label>
    <other_name>Acetaminophen 500Mg Suppository</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Stage 1:&#xD;
&#xD;
        a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree&#xD;
        tear or episiotomy) post vaginal delivery&#xD;
&#xD;
        Stage 2:&#xD;
&#xD;
          1. All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016&#xD;
             till 30th June 2016.&#xD;
&#xD;
          2. All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy&#xD;
             tear post vaginal delivery.&#xD;
&#xD;
          3. All pregnant women who have consented to involve in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Stage 1:&#xD;
&#xD;
          1. Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear)&#xD;
             following childbirth.&#xD;
&#xD;
          2. Patient who developed post-partum complications.&#xD;
&#xD;
        Stage 2:&#xD;
&#xD;
          1. Patient who is allergic to paracetamol or voltaren.&#xD;
&#xD;
          2. Patient who is unable to or unwilling to give consent.&#xD;
&#xD;
          3. Patient who is ended up with caesarean section.&#xD;
&#xD;
          4. Patient who sustained additional perineal tear including labial tear or periurethral&#xD;
             tear.&#xD;
&#xD;
          5. Patient who developed postpartum complications (eg. Retained placenta, uterine atony,&#xD;
             postpartum haemorrhage, multiple vaginal wall tear etc. )&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu Yuan Woon, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>O&amp;G department, Hospital Sultanah Aminah Johor Bahru, Malaysia</affiliation>
  </overall_official>
  <results_reference>
    <citation>Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.</citation>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>10352050</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15507941</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17196714</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>12917995</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23440827</PMID>
  </results_reference>
  <results_reference>
    <citation>Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.</citation>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Research Centre, Malaysia</investigator_affiliation>
    <investigator_full_name>Woon Shu Yuan</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Diclofenac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041779
org study id: NMRR-15-868-26140
nct id: NCT03041779
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: perineum pain score following childbirth
time frame: at 2nd to 3rd hour post repair
measure: perineum pain score following childbirth
time frame: immediate after delivery
measure: perineum pain score following childbirth
time frame: immediate post perineum repair
measure: perineum pain score following childbirth
time frame: at 5th to 6th hour post repair
measure: perineum pain score following childbirth
time frame: prior to discharge
arm group label: Paracetamol
arm group type: Active Comparator
description: Paracetamol 500Mg Suppository
arm group label: Voltaren
arm group type: Active Comparator
description: Diclofenac Sodium 50Mg Suppository
intervention type: Drug
intervention name: Diclofenac Sodium 50Mg Suppository
arm group label: Paracetamol
other name: Voltaren 50Mg Suppository
intervention type: Drug
intervention name: Paracetamol 500Mg Suppository
arm group label: Voltaren
other name: Acetaminophen 500Mg Suppository
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shu Yuan Woon, MBBS
role: Principal Investigator
affiliation: O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia
citation: Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.
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.
PMID: 10352050
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.
PMID: 15507941
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.
PMID: 17196714
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.
PMID: 12917995
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.
PMID: 23440827
citation: Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.
responsible party type: Principal Investigator
investigator affiliation: Clinical Research Centre, Malaysia
investigator full name: Woon Shu Yuan
investigator title: Doctor
mesh term: Lacerations
mesh term: Acetaminophen
mesh term: Diclofenac
sharing ipd: Undecided