Comparison of Never Performing Episiotomy to Performing it in a Selective Manor

Study Overview
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Brief Summary
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The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor.

Detailed Description
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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 Fisher's 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 Student's 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 196/96 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

Official Title
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Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial

Conditions
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Need of Episiotomy

Intervention / Treatment
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* Other: Never perform episiotomy
* Procedure: episiotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in active labor admitted to the maternity ward Term pregnancy (37-42 weeks gestation); Maximum Dilation 8cm; Live fetus in vertex position. Exclusion Criteria: hemorrhagic syndromes of pregnancy (premature separation of the normally implanted placenta Women with an indication for cesarean section: cephalopelvic disproportion (DCP), non reassuring fetal heart rate, dystocia; Women without capacity to consent and without legal guardians. Women undergoing cesarean delivery (post-randomization exclusion)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Never perform episiotomy<br>In this group the birth attendant will sought to avoid the use of episiotomy, and try not to carry out the procedure unless considered absolutely needed | Other: Never perform episiotomy<br>* In this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group.<br>|
| Active Comparator: Selective episiotomy<br>Patients will be subjected to the usual routine (selective episiotomy, ie, in the presence of indications described in the literature, according to the discretion of the physician or nurse assisting the birth) | Procedure: episiotomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the second stage of labor | Time in minutes from beginning of second stage of labor until the delivery of the baby | From beginning of second stage of labor to delivery of the baby | 
| frequency of episiotomy | Frequency of episiotomies in fact carried out | From diagnosis of second stage of labor to delivery of the neonate | 
| frequency of spontaneous lacerations | Frequency of spontaneous lacerations verified immediatly after delivery (time frame from randomization until one hour after delivery) | From randomizatyion to one hour after delivery | 
| blood loss at delivery | Volume of blood loss in mililiters, lost by the patient from the genital tract, from the moment of the delivery to one hour after delivery | from delivery to one hour postpartum | 
| perineal need of suturing | Perineal suturing carried out by the birth attendant | From delivery to one hour postpartum | 
| Apgar scores | one and five minutes Apgar scores | From delivery to five minutes after delivery | 
| need for neonatal resuscitation | Need of any resuscitation procedures carried out in the conduction of the neonate, from the time of birth until one hour after delivery | From delivery to one hour after delivery | 
| cord blood pH at birth | Cord blood pH ( hydrogen ion concentration) at birth collected just after delivery | From birth of the baby until first minute after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of severe perineal trauma | frequency of severe perineal trauma observed by the birth attendant | from delivery of the baby until one hour after delivery | 
| complications of perineal suture | presence of hematoma, or infection or dehiscence of perineal suture described in the patients records from the moment of the delivery until 15 days after the delivery | From delivery until 15 days after delivery | 
| perineal pain after childbirth | perineal pain after childbirth evaluated according to the visual scale and maternal satisfaction, the evaluation is carried from 24 to 48 hours after the delivery, before maternal discharge from the hospital | From 24 hours after delivery until 48 hours of the delivery | 
| admission of the newborn (NB) in the neonatal intensive care unit (ICU). | admission of the newborn (NB) in the neonatal intensive care unit (ICU). | from delivery until 28 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episiotomy, vaginal delivery, randomized, perineum