Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
REBEC |
Last refreshed on:
|
29 May 2023 |
Main ID: |
RBR-84xprt |
Date of registration:
|
09/03/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
The effect of non-pharmacological measures for pain relief in labor
|
Scientific title:
|
Review of non-pharmacological interventions for pain relief in labor |
Date of first enrolment:
|
01/06/2013 |
Target sample size:
|
|
Recruitment status: |
Recruitment completed |
URL:
|
http://ensaiosclinicos.gov.br/rg/RBR-84xprt |
Study type:
|
Intervention |
Study design:
|
Randomized clinical trial of treatment, controlled, parallel, double-blind, three-arm
|
Phase:
|
0
|
|
Countries of recruitment
|
Brazil
| | | | | | | |
Contacts
|
Name:
|
Angelita José
Henrique |
Address:
|
Rua Napoleão de Barros
04024-002
São Paulo
Brazil |
Telephone:
|
55115576-4430 |
Email:
|
angel.j.henrique@gmail.com |
Affiliation:
|
Universidade Federal de São Paulo - UNIFESP |
|
Name:
|
Angelita José
Henrique |
Address:
|
Rua Napoleão de Barros
04024-002
São Paulo
Brazil |
Telephone:
|
55115576-4430 |
Email:
|
angel.j.henrique@gmail.com |
Affiliation:
|
Universidade Federal de São Paulo - UNIFESP |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Voluntary without any clinical or obstetric disease; active phase of labor with efficient two or three in ten minutes uterine contractions and cervical dilatation minimum 3 cm; gestational age between 37 completed weeks to complete 42 weeks calculated by last menstrual period or the result of early ultrasound until the twentieth week of pregnancy; minimum age of 18 years old and maximum age of 55 years; pregnancy with single live fetus in cephalic presentation bent; Note greatest pain 5 on the pain scale
Exclusion criteria: Volunteers with indication of caesarean section at admission; use of anesthesia during labor; Tobacco use less than two hours; people with mental disorders that may affect their autonomy; have ingested caffeine in the last 10 hours; use psychoactive drugs; performed less than 06 prenatal visits; use of natural or synthetic corticosteroids; used analgesics least at least 6 hours
Age minimum:
18Y
Age maximum:
55Y
Gender:
F
|
Health Condition(s) or Problem(s) studied
|
C10.597.617.515
|
labor pain, Pain Measurement
|
Intervention(s)
|
Behavioural
|
E02.190
|
Group A: 43 pregnant women at low risk in the active phase of labor will not receive assistance for pharmacological pain relief through the bath with hot water spray for 30 minutes. Group B: 43 pregnant women at low risk in the active phase of labor will not receive pharmacological assistance for the relief of perineal pain through exercise with the Swiss ball for 30 minutes; Group C: 42 pregnant women at low risk in the active phase of labor will not receive pharmacological assistance for the relief of pain through the sprinkler bath with hot water and perineal exercise Swiss ball for 30 minutes.
|
E02.533
|
E02.779.483
|
Primary Outcome(s)
|
to reduce pain and stress observed in clinical and neuro-endocrine parturient after the use of non-pharmacological interventions hot spray bath and perineal exercises with Swiss ball The note of pain and anxiety for pain scale, the evolution of obstetric data delivery by cervical dilation, progression of the fetus in the birth canal by the plan: To assess these outcomes, the data pre and post time control interventions will be evaluated DeLee, will be held assessment of fetal well-being with the examination of cardiotocography, data related to maternal stress and adaptation to pain situation with measurement of blood pressure, pulse, respiration and dosages of the hormones cortisol, norepinephrine will be evaluated, epinephrine and salivary endorphin. Interventions will be offered randomly after randomization.
|
The study showed clinical and neuroendocrine reducing pain and stress
|
Secondary Outcome(s)
|
Secondary outcomes found showed no change in fetal well-being through the use of interventions for pain relief, there was progression of obstetric parameters related to labor and development to delivery, reduction of labor time
|
to maintain the fetal well-being observed in the parameters of the test cardiotocography verified by evaluating the baseline fetal heart rate, presence of absence of transient acceleration and deceleration in fetal heart rate, progression in the evolution of obstetric parameters checked through the evaluation of cervical dilatation and descent of the fetal presenting plans DeLee conferred by vaginal touch, smoothing the pattern of uterine contractions observed by recording the examination of cardiotocography, shortening the labor verified by elapsed time between the intervention and the birth, favoring the normal delivery verified by type of delivery occurred
|
Source(s) of Monetary Support
|
Fundação de Amparo à Pesquisa do Estado de São Paulo-FAPESP
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|