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临床试验/NCT05812560
NCT05812560Unknown不适用

Evaluation of a Protocolposturalchanges in Women Giving Birth Whith Epidural Analgesia. Clinical Trial.

Puerta de Hierro University Hospital2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
208
试验地点
2
主要终点
Expulsive time

研究概览

简要总结

. The pain that occurs during labor is controlled in our environment through epidural analgesia.

This mainly generates a sensory block but also a motor block that suppresses different reflexes physiological factors that facilitate the development of childbirth.

Being necessary to adapt obstetric care to this reality. Among which are the changes postures of the immobile pregnant woman. General Objective: To evaluate the impact of a mobilization protocol during labor in pregnant women with epidural analgesia versus usual mobilization.

Material and method Simple randomized clinical trial, in a 1:1 ratio. Population: nulliparous pregnant women and low-risk pregnancy, using epidural analgesia.

Inclusion criteria: nulliparous pregnant women at term and low-risk pregnancy, in the active phase of labor and with epidural analgesia, voluntarily participating in the study.

Sample size: Assuming an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided contrast, each group will contain 104 subjects to detect a difference 0.4 units.

The intervention of the experimental group will consist of the application of a protocol of postural changes every 30-60 minutes or at least two postural changes in one hour during labor, in order to expand the diameters pelvics in the different phases of this.

In the control group, each midwife will apply the postural changes according to her usual practice.

Differences with the experimental group: the choice of postural changes according to the stage of labor, its cadence and the posture during the expulsive.

详细描述

Justification:

Variability in clinical practice in this setting ranges from no postural changes at all, random postural changes unrelated to stage of labor, to changes frequently targeted at each stage of labor, with knowledge of the pelvis and the mechanisms of childbirth.

There are no validated procedures for mobilizing pregnant women with epidural analgesia during labor. This makes investigators think about the need to design a protocol for postural changes during labor and the training of the team of midwives. All of this aimed at offering unified and quality care to pregnant women, which is not only reversed in maternal-fetal results but also in greater maternal comfort and in the perception of quality care by the pregnant woman.

In this study we will focus on mitigating the motor effects of epidural analgesia on labor and expulsive periods by establishing standardized postural changes.

Hypothesis and objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Pregnant women older than 18 years, nulliparous at term and low risk in pregnancy will be included
  • They must be in the active phase of labor (3 cm dilated and regular contractions every 2-3 minutes9), with the intention of using epidural analgesia, showing no contraindications for such anesthesia, and wishing to participate voluntarily in the study.

排除标准

  • Those pregnant women who, during labor, the midwife cannot complete the registration, due to workload or the woman decides to abandon participation in the study, will be excluded.
  • Those participants in the experimental group who, for obstetric, maternal or fetal comfort reasons, cannot follow the protocol for postural changes will be eliminated from the study.

结局指标

主要结局

Expulsive time

时间窗: From the beginning to the end of the labor 12-24 hours

Expulsive time in minutes: period of labor that elapses between the moment in which full dilation is reached (10 cm of cervical dilation) and the moment in which fetal expulsion occurs.

Cervical dilation speed

时间窗: From the beginning to the end of the labor 12-24 hours

The dilation phase will be measured as dilation speed in cm/h,Dilation time: period of labor that elapses between 4 and 10 cm of dilation and is accompanied by regular dynamics

次要结局

  • Type of the delivery(It will be recorded at the end of delivery. 12-24 hours)

研究者

发起方
Puerta de Hierro University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

María de la Milagrosa Fontan Azpeitia

University degree in nursing specializing in obstetrics and gynecology

Puerta de Hierro University Hospital

研究点 (2)

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