Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05812560 |
| Other study ID # |
PI 176/21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Puerta de Hierro University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
- Evaluate the speed of dilation and expulsive time in both situations.
- Record the need for artificial amniorrhexis and oxytocin perfusion in both situations.
- Analyze the type of delivery according to the group to which the pregnant woman belongs.
- Examine the perineal state after childbirth in both situations.
- Evaluate the behavior of variables related to the extrauterine adaptation of the newborn
in both groups: apgar test, neonatal resuscitation, ph in blood from the umbilical
artery or vein.
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.
1. Dilation time: period of labor that elapses between 4 and 10 cm of dilation and is
accompanied by regular dynamics.
2. 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.
Secondary Variables
- Cervical dilation: opening of the uterine cervical opening. It will be measured through
vaginal examination and the unit will be centimeters, it will be recorded every two
hours throughout the labor in both groups.
- Type of amniorhexis: rupture of the amniotic bag, it can be of two types:
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.
- Use of oxytocin: the use or not of oxytocin at the end of labor will be recorded, as
well as the amount in IU/kg/hour administered,
- Type of delivery: eutocic delivery, which is one that does not require medical
intervention.
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.
- Umbilical cord blood pH: analysis of umbilical cord blood is an objective measure of
fetal condition before birth. The spanish association of pediatrics defines serious
neurological sequelae in children with arterial pH greater than 720 as infrequent. It
will be measured with a rediomether® brand abl90 flex pachymeter (The analyzer
incorporates an automatic quality control with specific QC solutions and performs also
continuous analytical checks of the system and undertakes automated corrective actions
when necessary.). The unit will be numbers with two decimal places and will be recorded
at the end of delivery.
- Score in the neonatal apgar test: Evaluates the newborn's adaptation to extrauterine
life, scores 5 parameters in the newborn: heart rate, respiratory effort, muscle tone,
response to stimuli and skin color. Each parameter is given a score of 0.1 or 2. The
maximum score will be 10 and the minimum 0. An apgar test above 7 indicates a good
adaptation to extrauterine life. An integer number from 0 to 10 will be recorded, at one
minute and at 5 minutes of the neonate's life. twenty-one
- Need for neonatal resuscitation and type: It is related to the need to apply support
measures to the newborn for its adaptation to extrauterine life. It will be measured in
numbers with a decimal from 0 to 5 according to the application of no measure 0,
aspiration of airway secretions 1, application of continuous positive airway pressure 2,
application of intermittent positive airway pressure 3, application of orotracheal
intubation 4, drug administration 5. It will be recorded according to the type after 10
minutes of the newborn's life. twenty-one.
Personal variables
- Age: it will be measured in years
- Obstetric history: pregnancies, abortions, deliveries and living children. It will be
measured in whole numbers.
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
1. The recruitment of the pregnant woman will be carried out upon admission to the delivery
unit by the responsible collaborating midwife.
2. The pregnant woman will be given the information sheet (annex 4) and two copies of the
informed consent (annex 5).
3. Once the pregnant woman carefully reads the study information and resolves her doubts
with said midwife, she will collect one of the signed copies of the informed consent,
the other will belong to the pregnant woman.
4. When participant proceed to grant his written consent, participant will be randomly
assigned to belong to the control group or the intervention group at random. The
randomization process will be carried out by all the women who come to our center and
agree to participate in the study, with prior information (annex 4) and sign the
informed consent (annex 5). Once recruited, the participants will have a number,
avoiding revealing the participant's personal data. Through the data collection
notebook, the number assigned to the study subject, the obstetric data of the pregnant
woman and the variables described above will be recorded.
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:
1. 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:
- sims
- Sitting with knee external rotation
- Walchers
- Modified lateral prone
B) Passive expulsive phase (vaginal examination ≥10 cm without contractions). The
following positions must be adopted:
-sims
- Sitting with knee external rotation
- Walchers
- Modified lateral prone
- modified sims
- Sitting with knee internal rotation
- Lateral decubitus with knee external rotation
- On knees with parallel or symmetrical legs
- McRoberts semi-sitting.
C) Active expulsive phases (vaginal examination ≥10 cm with contractions). The following
positions must be adopted:
- modified sims
- Sitting with knee internal rotation
- Lateral decubitus with knee external rotation
- On knees with parallel or symmetrical legs
- McRoberts semi-sitting. Control group: the midwife will develop postural changes
according to her usual practice. The existence of postural changes or not and the
time spent in each of the chosen positions will be recorded.
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).
- Review database, sanitation and complete information. Duration 1 months.
Simultaneously to the development of stage 2, the quality of the data obtained will
be assessed, to complete the missing information and to be able to carry out
intermediate analyses.
- Full analysis, dissemination of results and final report. Duration 2 months Once
the 208 study subjects have been recruited, a complete analysis of the database
will be carried out for the elaboration of the pertinent manuscripts and the
elaboration of the Final Report.
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.
