跳至主要内容
临床试验/NCT05268276
NCT05268276已完成不适用

The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)

Asmaa Abdallah Ahmed Hussein2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Severity of Postpartum Perineal Pain

研究概览

简要总结

the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To fulfill the aim of this study the following research hypothesis is formulated: H1: Post partum women with perineal trauma who will receive the designed protocol of care will have better perineal trauma outcomes than those who will receive the routine hospital care.Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed protocol of care will show better perineal trauma healing than those who will receive the routine hospital care.

Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed protocol of care will have less perineal pain score than those who will receive the routine hospital care.

详细描述

This randomized controlled trial will be conducted to test the effect of designed protocol of care that include; perineal ice-gel pad application for the first 24 hours after delivery, performance of pelvic floor exercises (Kegel exercises) for six hours till one week postpartum and perineal warm compresses application from 48 hours till one week postpartum on the outcomes of postpartum perineal trauma .The study will be conducted on (100) postpartum women with normal spontaneous vaginal delivery and having postpartum perineal trauma that randomly assigned to either study group (50) women or control group (50) women.The study will be conducted at postpartum ward of emergency department for labor and delivery in Obstetrics and Gynecology Hospital at Kasr El Aini University Hospital affiliated to Cairo University.Required data will be collected by using 5 tools: A) Structured interview schedule; B) Visual Analogue Scale for pain intensity(VAS); C) Visual Analogue Scale (VAS) for rating functional activities; D) Standardized REEDA scale; and E) Postpartum follow up sheet. the primary official permission will be obtained from the research ethics committee of faculty of nursing, Cairo University to approve the tools and the study. An official permission will be granted from the hospital administrative personnel in the recommended setting to collect the data. Then, data collection will be carried out through five steps in each group: Recruitment & randomization; interviewing; initial assessment; intervention; follow up and monitoring.

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
None

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria will be according to the following
  • primiparous or 2nd. multiparaous women with postpartum perineal trauma either episiotomy or perineal tear (first and second degree only)
  • age not exceeding 40 years
  • body mass index (BMI)within normal 18.5-24.9 kg/m2 or overweight 25-29.9 kg/m2,
  • free from any high risk condition affecting perineal trauma healing (e.g., diabetes mellitus or obesity),
  • over 37 week gestation
  • not having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument),
  • not having any immediate postnatal complications such as postpartum hemorrhage.

排除标准

  • 3rd or 4th degree perineal tear
  • age more than 40 years
  • having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument)
  • having any immediate postnatal complications such as postpartum hemorrhage. ]

结局指标

主要结局

Severity of Postpartum Perineal Pain

时间窗: one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery

Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).It is a self-reported 10 cm horizontal line which represents the subjective estimation of pain intensity. It comprises 0-10-point numerical scale, the two opposite ends representing no pain to severe pain as follows: no pain (0), mild pain (\< 4), moderate pain (4 - \< 8), and sever pain (8-10).

Postpartum Perineal Trauma Healing

时间窗: one hour after delivery, six hours after delivery, day 7after delivery

Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing

次要结局

  • Occurrence of Postpartum Perineal Trauma Infection(day 7 after delivery)
  • Postpartum Difficulty With Performing Functional Activity(24 hours after delivery, day 3 after delivery, day 5 after delivery)

研究者

发起方
Asmaa Abdallah Ahmed Hussein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asmaa Abdallah Ahmed Hussein

assisstant lecturer at faculty of nursing /cairo university

Cairo University

研究点 (2)

Loading locations...

相似试验