NCT03041779

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
909

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

December 12, 2016

Last Update Submit

February 1, 2017

Conditions

Perineal TearPerineal Laceration (Obstetric)

Outcome Measures

Primary Outcomes (1)

  • perineum pain score following childbirth

    at 2nd to 3rd hour post repair

Secondary Outcomes (4)

  • 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

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Paracetamol 500Mg Suppository

Drug: Diclofenac Sodium 50Mg Suppository

Voltaren

ACTIVE COMPARATOR

Diclofenac Sodium 50Mg Suppository

Drug: Paracetamol 500Mg Suppository

Interventions

Diclofenac Sodium 50Mg SuppositoryDRUG
Also known as: Voltaren 50Mg Suppository
Paracetamol
Paracetamol 500Mg SuppositoryDRUG
Also known as: Acetaminophen 500Mg Suppository
Voltaren

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.

    RESULT

  • 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: 10352050RESULT

  • 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: 15507941RESULT

  • 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: 17196714RESULT

  • 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: 12917995RESULT

  • 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: 23440827RESULT

  • Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.

    RESULT

MeSH Terms

Interventions

DiclofenacSuppositoriesAcetaminophen

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsDosage FormsPharmaceutical PreparationsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Shu Yuan Woon, MBBS

    O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 12, 2016

First Posted

February 3, 2017

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02