Comparison of Never Performing Episiotomy to Performing it in a Selective Manor (EPISIO)

November 16, 2016 updated by: Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • IMIP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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
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.
ACTIVE_COMPARATOR: 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)
Procedure: episiotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
duration of the second stage of labor
Time Frame: From beginning of second stage of labor to delivery of the baby
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
Time Frame: From diagnosis of second stage of labor to delivery of the neonate
Frequency of episiotomies in fact carried out
From diagnosis of second stage of labor to delivery of the neonate
frequency of spontaneous lacerations
Time Frame: From randomizatyion to one hour after delivery
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
Time Frame: from delivery to one hour postpartum
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
Time Frame: From delivery to one hour postpartum
Perineal suturing carried out by the birth attendant
From delivery to one hour postpartum
Apgar scores
Time Frame: From delivery to five minutes after delivery
one and five minutes Apgar scores
From delivery to five minutes after delivery
need for neonatal resuscitation
Time Frame: From delivery to one hour after delivery
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
Time Frame: From birth of the baby until first minute after delivery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
frequency of severe perineal trauma
Time Frame: from delivery of the baby until one hour after delivery
frequency of severe perineal trauma observed by the birth attendant
from delivery of the baby until one hour after delivery
complications of perineal suture
Time Frame: From delivery until 15 days after delivery
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
Time Frame: From 24 hours after delivery until 48 hours of the delivery
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).
Time Frame: from delivery until 28 days after birth
admission of the newborn (NB) in the neonatal intensive care unit (ICU).
from delivery until 28 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Materno Infantil Prof. Fernando Figueira

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Inês Melo, MS, IMIP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPISIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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