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临床试验/NCT03041779
NCT03041779已完成2 期

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

Clinical Research Centre, Malaysia0 个研究点目标入组 909 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
909
主要终点
perineum pain score following childbirth

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery
  • All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June
  • 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.

排除标准

  • Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
  • Patient who developed post-partum complications.
  • 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. )

研究组 & 干预措施

Paracetamol

Active Comparator

Paracetamol 500Mg Suppository

干预措施: Diclofenac Sodium 50Mg Suppository (Drug)

Voltaren

Active Comparator

Diclofenac Sodium 50Mg Suppository

干预措施: Paracetamol 500Mg Suppository (Drug)

结局指标

主要结局

perineum pain score following childbirth

时间窗: at 2nd to 3rd hour post repair

次要结局

  • perineum pain score following childbirth(prior to discharge)

研究者

发起方
Clinical Research Centre, Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Woon Shu Yuan

Doctor

Clinical Research Centre, Malaysia

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