Clinical trial NCT02178111: Comparison of Never Performing Episiotomy to Performing it in a Selective Manor
Official title: Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Need of Episiotomy
Keywords: episiotomy, vaginal delivery, randomized, perineum
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 237
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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)

Primary outcomes:
measure: duration of the second stage of labor
timeFrame: From beginning of second stage of labor to delivery of the baby
measure: frequency of episiotomy
timeFrame: From diagnosis of second stage of labor to delivery of the neonate
measure: frequency of spontaneous lacerations
timeFrame: From randomizatyion to one hour after delivery
measure: blood loss at delivery
timeFrame: from delivery to one hour postpartum
measure: perineal need of suturing
timeFrame: From delivery to one hour postpartum
measure: Apgar scores
timeFrame: From delivery to five minutes after delivery
measure: need for neonatal resuscitation
timeFrame: From delivery to one hour after delivery
measure: cord blood pH at birth
timeFrame: From birth of the baby until first minute after delivery
Secondary outcomes:
measure: frequency of severe perineal trauma
timeFrame: from delivery of the baby until one hour after delivery
measure: complications of perineal suture
timeFrame: From delivery until 15 days after delivery
measure: perineal pain after childbirth
timeFrame: From 24 hours after delivery until 48 hours of the delivery
measure: admission of the newborn (NB) in the neonatal intensive care unit (ICU).
timeFrame: from delivery until 28 days after birth
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
Study officials:
affiliation: IMIP
name: Maria Inês Melo, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: M Amorim M, Coutinho IC, Melo I, Katz L. Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial. Reprod Health. 2017 Apr 24;14(1):55. doi: 10.1186/s12978-017-0315-4.
citation: Melo I, Katz L, Coutinho I, Amorim MM. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial. Reprod Health. 2014 Aug 14;11:66. doi: 10.1186/1742-4755-11-66.