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

A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth

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.

Study Overview

• Status: Completed
• Conditions: Perineal Tear; Perineal Laceration (Obstetric)
• Intervention / Treatment: Drug: Diclofenac Sodium 50Mg Suppository; Drug: Paracetamol 500Mg Suppository

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: Interventional
• Enrollment (Actual): 909
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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. )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paracetamol; Paracetamol 500Mg Suppository	Drug: Diclofenac Sodium 50Mg Suppository; Other Names: Voltaren 50Mg Suppository
Active Comparator: Voltaren; Diclofenac Sodium 50Mg Suppository	Drug: Paracetamol 500Mg Suppository; Other Names: Acetaminophen 500Mg Suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
perineum pain score following childbirth	at 2nd to 3rd hour post repair

Secondary Outcome Measures

Outcome Measure	Time Frame
perineum pain score following childbirth	immediate after delivery
perineum pain score following childbirth	immediate post perineum repair
perineum pain score following childbirth	at 5th to 6th hour post repair
perineum pain score following childbirth	prior to discharge

Collaborators and Investigators

• Sponsor: Clinical Research Centre, Malaysia
• Investigators: Principal Investigator: Shu Yuan Woon, MBBS, O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia

Publications and helpful links

General Publications

• Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.
• 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.
• 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.
• 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.
• 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.
• 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.
• Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Diclofenac
• Other Study ID Numbers: NMRR-15-868-26140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No