Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03041779
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Woon Shu Yuan, Clinical Research Centre, Malaysia

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
perineum pain score following childbirth [ Time Frame: at 2nd to 3rd hour post repair ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • perineum pain score following childbirth [ Time Frame: immediate after delivery ]
  • perineum pain score following childbirth [ Time Frame: immediate post perineum repair ]
  • perineum pain score following childbirth [ Time Frame: at 5th to 6th hour post repair ]
  • perineum pain score following childbirth [ Time Frame: prior to discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear
Official Title  ICMJE A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Perineal Tear
  • Perineal Laceration (Obstetric)
Intervention  ICMJE
  • Drug: Diclofenac Sodium 50Mg Suppository
    Other Name: Voltaren 50Mg Suppository
  • Drug: Paracetamol 500Mg Suppository
    Other Name: Acetaminophen 500Mg Suppository
Study Arms  ICMJE
  • Active Comparator: Paracetamol
    Paracetamol 500Mg Suppository
    Intervention: Drug: Diclofenac Sodium 50Mg Suppository
  • Active Comparator: Voltaren
    Diclofenac Sodium 50Mg Suppository
    Intervention: Drug: Paracetamol 500Mg Suppository
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
909
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. )
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041779
Other Study ID Numbers  ICMJE NMRR-15-868-26140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Woon Shu Yuan, Clinical Research Centre, Malaysia
Study Sponsor  ICMJE Clinical Research Centre, Malaysia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shu Yuan Woon, MBBS O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia
PRS Account Clinical Research Centre, Malaysia
Verification Date February 2017

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