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

NCT ID: NCT02178111

Last Updated: 2016-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-09-30

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

Conditions

Need of Episiotomy

Keywords

episiotomy, vaginal delivery, randomized, perineum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Never perform episiotomy

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

Group Type: EXPERIMENTAL

Never perform episiotomy

Intervention Type: OTHER

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

Selective episiotomy

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)

Group Type: ACTIVE_COMPARATOR

episiotomy

Intervention Type: PROCEDURE

Interventions

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.

Intervention Type: OTHER

episiotomy

Intervention Type: PROCEDURE

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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Leila Katz

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Inês Melo, MS

Role: PRINCIPAL_INVESTIGATOR

IMIP

Locations

IMIP

Recife, Pernambuco, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28438209 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25124938 (View on PubMed)

Other Identifiers

EPISIO

Identifier Type: -

Identifier Source: org_study_id