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
About this trial
This is an interventional treatment trial for Perineal Tear
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. )
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
NCT ID
NCT03041779
First Posted
December 12, 2016
Last Updated
February 1, 2017
Sponsor
Clinical Research Centre, Malaysia
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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