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临床试验/NCT06428812
NCT06428812已完成不适用

Phd Student Msc Midwife

Öznur Hayat Öktem2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年7月8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
60
试验地点
2
主要终点
Perineal Pain

研究概览

简要总结

This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually.

详细描述

The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary, genital and gastrointestinal systems. When tissues in a region of the pelvic floor are damaged for any reason, pelvic floor dysfunction develops.

Pregnancy and childbirth are important risk factors for pelvic floor dysfunction. Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function. During pregnancy, weight gain and increase in uterine weight increase intra-abdominal pressure. Therefore, ligaments and pelvic floor muscles are overstretched. He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger. During the passage and descent of the fetal head through the vaginal canal, the pelvic floor muscles can be overstretched, torn or damaged. Obstetric factors that cause pelvic floor damage include early or late age at first birth, high body mass index, large baby, length of the second stage of trauma (labor), forceps, vacuum, episiotomy and fundal compression.

Damage to the pelvic floor during labor has many short- and long-term effects on a woman's quality of life. These can be summarized as chronic perineal pain, pelvic organ prolapse, urinary and anal incontinence, fistula, sexual dysfunction, labor dissatisfaction, physical and psychological morbidities, and decreased quality of life. In addition, breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period. Therefore, it is important to prevent pelvic floor damage in childbirth, which negatively affects physical, social and psychological well-being and leads to many short and long-term morbidities. The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery.

In the literature, there are many studies examining interventions to protect the pelvic floor in labor. Studies show that perineal massage, perineal warm application, birth positions, hand maneuvers, pushing techniques, and limited episiotomy reduce the incidence of perineal injury.

However, studies on these techniques and practices are generally studies investigating the effectiveness of a single method. In a recent qualitative study, midwives were asked to evaluate the effect of some protective practices called; perineal package; as a whole. However, in this study, midwives; own practices and opinions were evaluated, and their effects on the pelvic floor or labor were not examined. International organizations recommend the application of evidence-based, perineal, and pelvic floor supportive and protective methods to pregnant women in labor. However, the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence, which are indicators of pelvic floor damage, is unclear and studies to evaluate this relationship are limited.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18- 35 years old
  • Singleton pregnancy in the vertex position between 38 and 42 weeks
  • A reactive NST tracing
  • Without a systemic disease (heart, HT, diabetes)
  • No problem speaking and understanding Turkish
  • Who agreed to participate in the study

排除标准

  • Obese pregnant women
  • Pregnant women who gained more than 25 kilograms during pregnancy
  • Multiple pregnancies
  • Pregnant women with a neurological disease affecting the pelvic floor
  • Pregnant women who have undergone pelvic surgery
  • Contraindications for normal delivery (placenta previa, anomalies of presentation, etc.)
  • Estimated fetal weight of 4000 g or more
  • Who wants to opt out of the study
  • Pregnant women who are scheduled for cesarean section at any time of trauma

结局指标

主要结局

Perineal Pain

时间窗: 1st hour postpartum

Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum.

Perineal muscle strengt

时间窗: On initial admission to the delivery room and after 6 weeks postpartum

Perineal muscle strength will be measured in cmH2o with a perineometer.

次要结局

  • Urinary incontinence status(6 weeks postpartum)
  • Episiotomy and laseration status(1st hour postpartum)

研究者

发起方
Öznur Hayat Öktem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Öznur Hayat Öktem

Phd student Msc midwife

Gulhane School of Medicine

研究点 (2)

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