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临床试验/NCT04823598
NCT04823598已完成不适用

Comparing Spontaneous Versus Interventionist Approaches: A Randomized Controlled Study on the Impact of Manual Perineal Protection and Pushing Techniques on Perineal Outcomes in Nulliparous Women

Istinye University2 个研究点 分布在 2 个国家目标入组 164 人开始时间: 2021年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
2
主要终点
Episiotomy

研究概览

简要总结

Perineal trauma during vaginal delivery is very common, especially in countries with a high prevalence of episiotomy. Perineal traumas can range from tears limited to the skin, subcutaneous and vaginal mucosa to severe tears involving the anal sphincter and rectal mucosa. Perineal trauma is associated with short-term morbidities such as bleeding, infection, pain, edema. Besides, it may cause long-term morbidities such as urinary incontinence, fecal incontinence, dyspareunia, a decrease in quality of life, a need for surgery, and psychosocial problems. Moreover, it is associated with an increase in national healthcare costs and malpractice cases. For these reasons, some measures to reduce the frequency of perineal trauma have been discussed for many years. Pushing techniques applied in the second stage of labor and manual perineum protection techniques applied during fetal expulsion are among these. Current data are insufficient to make definitive recommendations. In this study, it was aimed to compare different pushing and perineal protection techniques in the second stage of labor.

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 (Care Provider)

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

  • Nulliparity
  • 37-40 weeks of gestation
  • Singleton pregnancy
  • Vertex presentation
  • Risk-free pregnancy
  • Estimated fetal weight 2500-4000 g
  • In the first stage of birth
  • Amniotic membranes are intact
  • Adequate knowledge of written and spoken Turkish

排除标准

  • Cesarean delivery need
  • Need for labor induction
  • Need for operative delivery (vacuum, forceps)
  • Need for obstetric analgesia
  • Kristaller maneuver
  • Perineal preparation during pregnancy (perineal massage in the last month of pregnancy, etc.)
  • Vulvo-vaginal infection
  • Vulvar severe varicose veins
  • Postpartum atony
  • Non-compliance with research follow-up criteria
  • Covid-19 positivity
  • Non-compliance with the procedure of the group involved
  • Neuropsychiatric and other diseases that cause understanding, speech, and expression disorders

结局指标

主要结局

Episiotomy

时间窗: between the end of the second stage of labor and fetal expulsion

Episiotomy rates

Perineal lacerations

时间窗: between the end of the second stage of labor and fetal expulsion

Frequency of perineal lacerations according to their severity

次要结局

  • Perineal pain(24th hour after birth)
  • Breastfeeding(24th hour after birth)
  • Pelvic muscle function(1th month after birth)
  • Maternal birth satisfaction(24th hour after birth)
  • Anal incontinence(1th month after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Refika Genc Koyuncu

assistant professor

Istinye University

研究点 (2)

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