Status
Conditions
Treatments
About
. 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.
Full description
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:
The implementation of a protocol that standardizes postural changes during labor in nulliparous pregnant women with epidural analgesia will have an impact on dilation and expulsive times, improving obstetric and perinatal outcomes that are universally measured with the type of delivery, the perineal status, the apgar test at one minute and ten minutes of neonatal life and the ph result of umbilical cord blood. 9 General objective to evaluate the impact of a mobilization protocol during labor versus conventional mobilization in nulliparous pregnant women with epidural analgesia.
Specific objectives
Methodology:
type of study Simple randomized clinical trial with parallel groups, single center, carried out in a tertiary hospital of the Madrid Health Service. Participants will be randomly assigned to each of the groups in a 1:1 ratio. Randomization will be carried out using a list of random numbers with the Epidad program (version 3.1) and masking using sealed and sequentially numbered envelopes.
Study population Nulliparous pregnant women with a low risk in the evolution of the gestation17 who make use of epidural analgesia and go to the hospital under study for delivery care.
Inclusion, exclusion and elimination criteria 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.
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.
Sample size Accepting an alpha risk of 0.05 and a beta risk of 0.2 on a two-sided contrast, it takes 104 subjects in each arm to detect a difference of 0.4 time units. The common standard deviation is assumed to be 1. A rate of loss to follow-up of 5% has been estimated. Data extrapolated from previous studies. 19 (calculated using the program grammo V.7.12) Main Variable • Time of labor: the time in minutes that elapses of labor will be recorded (dilation phase + expulsive phase). For this, a bodet brand digital clock will be used, which will be calibrated every 24 hours. The dilation phase will be measured as dilation velocity in cm/h and the expulsive phase in min.
Secondary Variables
artificial (when carried out by the midwife or obstetrician using a sterile amniorhexis lancet): if cervical dilation in 4 hours < 2 cm with amniotic bag integrates, perform artificial amniorrhexis and if after two hours cervical dilation is < 1 cm administer oxytocin910 spontaneous: In this case, a dose of oxytocin will be administered according to the international recommendation of clinical practice guidelines10.
It will be recorded only once when it happens.
Dystocic delivery, after a change in normality, requires an obstetric intervention, which may be: instrumental (if an obstetric instrument such as forceps, spatulas, or a suction cup is used to extract the fetus) or caesarean section (when a consistent surgical intervention is carried out). in fetal extraction through an incision in the abdomen of the pregnant woman to access the uterine cavity). It will be recorded at the end of delivery.
Personal variables
Gestational age: time that elapsed from the date of the last period of the pregnant woman until her recruitment for the study, will be measured in whole weeks.
Recruitment and management of pregnant women
Preparation Preparation of the midwives: the midwives who are part of the study must have a minimum of 10 years' experience in assisting women in childbirth, as well as training in obstetric simulation. They will be informed of the object of the study (annex 1) and will receive training to standardize data collection. The total number of midwives will be divided into two groups: 1. Those who will carry out mobilizations according to their usual practice and 2. Those who will carry out the experimental mobilization protocol, which will receive a specific training module to be able to carry it out.
Training for professionals: to standardize data collection, training will be provided to all professionals participating in the study. This training will consist of 3 sections:
Introduction; 2. Necessity and justification of the investigation; 3. Practical examples for training in the collection of variables (Annex 2).
The session will be held online and its duration will be one hour. The midwives of the experimental group, in addition to general training, will receive a separate face-to-face module to be able to carry out the experimental mobilization protocol. In this session, the different positions will be explained and training will be carried out through simulated cases. The session will last 2 hours.
Intervention experimental group. Mobilization protocol: 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 must be chosen based on the comfort of the woman. These positions are set out below, finding in annex 3 more details of them.
A) Active phase of dilation (vaginal examination >4 cm and <10 cm). The following positions must be adopted:
B) Passive expulsive phase (vaginal examination ≥10 cm without contractions). The following positions must be adopted:
-sims
C) Active expulsive phases (vaginal examination ≥10 cm with contractions). The following positions must be adopted:
modified sims
Sitting with knee internal rotation
In both groups, from the beginning of labor until the end of it, the midwife will perform a vaginal examination every 2 hours, evaluating the stage of labor in which the pregnant woman is.
Once the delivery is over, the responsible midwife will file the informed consent and the data notebook.
Ethical aspects The study will be carried out in accordance with the declaration of Helsinki, compliance with the biomedical research law and compliance with good clinical practice standards, which include study monitoring to ensure data quality and subject protection. participants. The study protocol will be reviewed and approved by the huphm clinical research ethics committee. Before beginning any procedure, the informed consent of the participants will be obtained. The confidentiality of the information and the anonymity of the participants will be guaranteed in compliance with organic law 3/2018, of december 5, on the protection of personal data and guarantee of digital rights.
Limitations and strengths of the study Limitations: double blinding. The complete application of the protocol due to the influence of foreign variables such as: maternal or fetal comfort or the type of delivery such as an instrumental delivery.
The variability in the assessment of cervical dilation, which was attempted to be alleviated with the experience and simulation training of midwives.
Strengths:
It is a non-bloody intervention, since it is based on the adoption of positions, without having to invade the body or administer poisons for therapeutic purposes.
If we obtain the desired results, and really as the literature suggests, this intervention contributes to improving obstetric and perinatal outcomes, it will have a great impact on the quality of care offered to pregnant women and their children. And it can be quickly implemented by the entire obstetric team given the simplicity of the postural change protocol.
Means available to carry out the project • Human resources: nurses specialized in obstetrics and gynecology who wish to participate, belonging to the obstetric block team at huph Majadahonda.
• Material means: necessary stationery for data collection notebooks, information sheets, protocol.
Study development schedule • Documentary support and CEIC. Duration 7 months Administrative procedures: review of the data collection Notebook (CRD) and the mobilization protocol by the midwives of the research team.
Presentation of the study to the clinical research ethics committee of the puerta de hierro majadahonda university hospital.
Pilot Study: a pilot study will be carried out, recruiting 6 pregnant women per group, to evaluate the recruitment procedures, information (hip and ic), randomization, follow-up, completion of the data collection Notebook and information collection. The entire research team will participate in this first stage.
Communication to the team: in this phase the meeting of researchers will be held, in which the research protocol will be reviewed and the results of the pilot study will be communicated.
• Patient recruitment and data collection. Duration 12 months depending on the pregnant women who meet the inclusion criteria and the recruitment capacity of the research team. It will be carried out by the midwives who wish to participate in the study, by the midwives of the research team.
The study will be carried out in the obstetrics service of the puerta de hierro Majadahonda university hospital (Madrid).
Once the results of the study are known, the priority is to make them known to the entire Obstetrics Service by presenting them in a Clinical session and delivering an abbreviated report.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
208 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal