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

NCT05812560 | Unknown DMC

• 1 other identifier: PI 176/21
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Movement; Postural change; Childbirth; Epidural analgesia.

Outcome Measures

Primary Outcomes (2)

• Cervical dilation speed

  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

  From the beginning to the end of the labor 12-24 hours

• Expulsive time

  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.

  From the beginning to the end of the labor 12-24 hours

Secondary Outcomes (1)

• Type of the delivery

  It will be recorded at the end of delivery. 12-24 hours

Study Arms (2)

Intervetion

EXPERIMENTAL

The intervention of the experimental group: application of a protocol of postural changes every 30-60 min or at least two postural changes in one hour during labor.

Other: postural changes

Control

NO INTERVENTION

In the control group, each midwife will apply postural changes according to their usual practice. Differences with the experimental group: the choice of postural changes according to the stage of labor, its cadence and posture during the expulsive.

Interventions

postural changes OTHER

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

Intervetion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women older than 18 years, nulliparous at term and low risk in pregnancy will be included17. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Maria de la Milagrosa Fontan Azpeitia

Madrid, 28232, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University degree in nursing specializing in obstetrics and gynecology

Model Details: Pregnant women will make 2 postural changes every 60 min throughout labor, preferably every 30 min. The positions will be different depending on the phase of labor in which the pregnant woman is. Those that correspond to each period have been chosen based on the comfort of the woman. These positions are set out below, finding in annex 3 more details of them.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: April 13, 2023
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)