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临床试验/NCT02492152
NCT02492152Unknown不适用

Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth

Meir Medical Center0 个研究点目标入组 400 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
number of women who will go through episiotomy and vaginal tears during birth

研究概览

简要总结

The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.

详细描述

The risk for vaginal tears during birth is about 20%. These tears require surgical repair, are painful and make the recovery of the mother more difficult. Less commonly there is a risk of tear infection and regional scarring that make intercourse more difficult. Moreover, according to some studies, it appears that there is a link between damage to the pelvic floor and vagina during labor and Urinary incontinence in stress later in life.

It is clear that there is an advantage for the prevention of vaginal tears. Dianatal is a gel preparation, designed for use in births, in order to reduce the rate of vaginal tears and possibly shorten the second stage of labor.

Tested and found that using the gel reduces friction on tissue in processes simulating pressure of birth and therefore it is less likely to see tears in the vaginal tissue when using gel.

The product is approved for use by the ministry of health, was safety approved by regulatory bodies in Switzerland - the country of production.

So far, there is only one study published in the professional literature. The study found that using the gel at birth, reduces the duration of the second stage (full opening to the birth of the fetus) and reduces the rate of tears. The aim of the work was to investigate the effect of the product on the duration of labor. Women on their first birth, were divided randomly into two groups, one was treated with Dianatal from the stage of active labor, and the other group did not receive any treatment. In each research group were about ninety women. This is the single research in one population. In addition, the research group is too small to have statistical power in order to answer issues related to the number of vaginal tears and the need to perform episiotomies.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women on their first Childbirth
  • Singleton pregnancy
  • Over 37 weeks of pregnancy
  • In active labor
  • Women who intend to have a vaginally birth
  • Women aged 18-45

排除标准

  • Multiple pregnancy
  • Births before 37 weeks
  • History of tear degree III or more
  • Women who intended to give birth by Caesarean section

结局指标

主要结局

number of women who will go through episiotomy and vaginal tears during birth

时间窗: A year and a half

次要结局

  • Time of delivery(A year and a half)
  • Number of spontaneous vaginal births (that are not Instrumental deliveries)(A year and a half)
  • Number of women who will have post-delivery complications such as fever after childbirth, vaginal hematomas requiring intervention, long hospitalizations after birth.(A year and a half)

研究者

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

Biron tal

MD

Meir Medical Center

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