Ignite Creation Date:
2024-05-06 @ 2:59 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02178111
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2014-06-16
Brief Title:
Comparison of Never Performing Episiotomy to Performing it in a Selective Manor
Sponsor:
Instituto Materno Infantil Prof Fernando Figueira
Organization:
Instituto Materno Infantil Prof Fernando Figueira
Study Overview
Official Title:
Not Performing Episiotomy Versus Selective Episiotomy a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPISIO
Brief Summary:
The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor
Detailed Description:
World Health Organization recommends that the rate of episiotomy in various departments will be around 10 which is already a reality in many European countries The episiotomy should be limited and physicians should be encouraged to use their clinical judgment to decide when the procedure is necessary There are no clinical evidence corroborating any indication of episiotomy so not yet known whether episiotomy is indeed necessary in any context obstetric practice Objectives To compare the maternal and perinatal outcomes in women undergoing a protocol of not conducting episiotomy versus selective episiotomy Methods A randomized clinical trial will be conducted in open Maternity Instituto de Medicina Integral Prof Fernando Figueira from August 2012 to July 2013 340 women will be included in labor with term pregnancy maximum dilation of 8 cm live fetus in cephalic vertex presentation and will be excluded women with bleeding disorders of pregnancy indication for caesarean section women without capacity to consent and without legal guardians The primary outcomes will be frequency of episiotomy delivery duration frequency of spontaneous lacerations frequency of instrumental delivery frequency of perineal trauma postpartum blood loss need for perineal suturing number of sutures Apgar scores at one and five minutes need for neonatal resuscitation and pH in cord blood As secondary outcomes will be assessed frequency of severe perineal trauma complications of perineal suturing perineal pain postpartum evaluated according to the visual scale maternal satisfaction neonatal morbidity and admission RN in NICU Women will be invited to participate and those who agree should signing the consent form At the beginning of the second stage will open the envelope to determine which group included women with 170 assigned to a protocol of not conducting episiotomy experimental group and 170 to a group that episiotomy is performed selectively Control Group according to the judgment of the provider of care delivery Statistical analysis will be performed using the Epi-Info statistical program 7 adopting the principle of intention to treat The analysis will be performed with the groups identified as A or B by a blinded statistician to the meaning of the lyrics breaking the secrecy only after the results obtained and prepared the tables Categorical variables were compared in contingency tables using the chi-square test of association and Fishers exact test as appropriate The risk ratio RR shall be calculated as measure of relative risk determining the confidence interval at 95 Regarding the quantitative variables if they have normal distribution comparison between groups will be conducted through the Students t test for unpaired samples If it is found that the distribution is not normal the nonparametric Mann-Whitney-will be used Ethical aspects the present study addresses the Resolution 19696 of the National Health Council and will be submitted to the iMIP Research Ethics Committee beginning only after your approval All participants will be included only if they agree to voluntarily participate by signing the consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None