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Evaluation of a Protocol Posturalchanges in Women Giving Birth With Epidural Analgesia. Clinical Trial.

NCT05812560 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2023-04-21

No results posted yet for this study

Summary

. 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.

Conditions

  • Epidural Analgesia
  • Nulliparous Pregnant
  • Labor With Postural Changes
  • Randomized

Interventions

OTHER

postural changes

application of a protocol of postural changes every 30-60 min or at least two postural changes in one hour during labor.

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-02-01
Completion
2024-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812560 on ClinicalTrials.gov