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

Need of Episiotomy Clinical Trial

— EPISIO  

Official title:

Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178111
• Other study ID #: EPISIO
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2014
• Last updated: November 16, 2016
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2016
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Need of Episiotomy

Intervention

Other:
• Never perform episiotomy
In this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group.

Procedure:
• episiotomy

Locations

Country	Name	City	State
Brazil	IMIP	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	frequency of episiotomy	Frequency of episiotomies in fact carried out	From diagnosis of second stage of labor to delivery of the neonate	No
Primary	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	No
Primary	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	No
Primary	perineal need of suturing	Perineal suturing carried out by the birth attendant	From delivery to one hour postpartum	No
Primary	Apgar scores	one and five minutes Apgar scores	From delivery to five minutes after delivery	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No