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

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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

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.

Condition or disease Intervention/treatment Phase
Perineal Tear Perineal Laceration (Obstetric) Drug: Diclofenac Sodium 50Mg Suppository Drug: Paracetamol 500Mg Suppository Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 909 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth Tears

Arm Intervention/treatment
Active Comparator: Paracetamol
Paracetamol 500Mg Suppository
Drug: Diclofenac Sodium 50Mg Suppository
Other Name: Voltaren 50Mg Suppository

Active Comparator: Voltaren
Diclofenac Sodium 50Mg Suppository
Drug: Paracetamol 500Mg Suppository
Other Name: Acetaminophen 500Mg Suppository




Primary Outcome Measures :
  1. perineum pain score following childbirth [ Time Frame: at 2nd to 3rd hour post repair ]

Secondary Outcome Measures :
  1. perineum pain score following childbirth [ Time Frame: immediate after delivery ]
  2. perineum pain score following childbirth [ Time Frame: immediate post perineum repair ]
  3. perineum pain score following childbirth [ Time Frame: at 5th to 6th hour post repair ]
  4. perineum pain score following childbirth [ Time Frame: prior to discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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. )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041779


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

Publications of Results:
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Responsible Party: Woon Shu Yuan, Doctor, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT03041779     History of Changes
Other Study ID Numbers: NMRR-15-868-26140
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diclofenac
Lacerations
Wounds and Injuries
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action