Evidence map›Paper›PMID 28438209›Full record

Trial reportReproductive health2017

Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial.

M M Amorim, Isabela Cristina Coutinho, Inês Melo, Leila Katz

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Reproductive health, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02178111 (Not Performing Episiotomy Versus Selective Episiotomy), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02178111 phase4completednot on this map

Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial

TypeinterventionalSponsorInstituto Materno Infantil Prof. Fernando FigueiraRan2014 to 2014Enrolled237ConditionsNeed of EpisiotomyArmsNever perform episiotomy, episiotomy
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  5. Observational
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  12. Observational
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  18. Knowledge, Attitude and Practice of Brazilian Obstetricians Regarding Episiotomy.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2019
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

M M AmorimInstituto de Medicina Integral Prof. Fernando Figueira, Women's Healthcare Centre, 50070-550, Recife, Pernambuco, Brazil. melania.amorim@gmail.com.
Isabela Cristina CoutinhoInstituto de Medicina Integral Prof. Fernando Figueira, Women's Healthcare Centre, 50070-550, Recife, Pernambuco, Brazil.
Inês MeloInstituto de Medicina Integral Prof. Fernando Figueira, Women's Healthcare Centre, 50070-550, Recife, Pernambuco, Brazil.
Leila KatzInstituto de Medicina Integral Prof. Fernando Figueira, Women's Healthcare Centre, 50070-550, Recife, Pernambuco, Brazil.
Instituto de Medicina Integral Professor Fernando Figueira · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite all the evidence corroborating the selective use of episiotomy and although routine use of the procedure is contraindicated, there are no evidences corroborating if episiotomy is necessary in any circumstance. The present clinical randomized trial was performed to compare maternal and perinatal outcomes in women submitted to a non-episiotomy protocol versus one of selective episiotomy.

methodsAn open-labelled, randomized clinical trial was carried out in a tertiary teaching hospital in Recife, Northeastern Brazil. Women in labor with a full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were included. Exclusion criteria consisted of bleeding disorders and an indication for a caesarean section. After signing the consent form, 241 women were randomized to a non-episiotomy protocol (the experimental group) or to a selective episiotomy group (the control group). No episiotomies were to be performed in the experimental group except under exceptional circumstances. In the control group, selective episiotomies were to be performed in accordance with the healthcare professionals' clinical judgement. Maternal and perinatal outcomes were evaluated. Ratio Risk (RR) and the 95% confidence interval (95% CI) were calculated for our outcomes.

resultsThe analysis include 115 women assigned to a non-episiotomy protocol and 122 to selective episiotomy. There was no difference between the two groups with respect to maternal or perinatal outcomes. The episiotomy rate was similar (two cases in each group, about 1.7%), as was the duration of the second stage of labor, the frequency of perineal tears, severe perineal trauma, need for perineal suturing and blood loss at delivery.

conclusionsA non-episiotomy protocol appears to be safe for mother and child, and highlights the need to investigate whether there is, in fact, any indication for this procedure.

trial registrationThis trial was registered at ClinicalTrials.gov under reference number ( NCT02178111 ).

Indexed as

Health Plan ImplementationPractice Guidelines as TopicAdolescentAdultBrazilDelivery, ObstetricEpisiotomyFemaleGuideline AdherenceHumansObstetric Labor ComplicationsPregnancyPregnancy OutcomeYoung AdultEpisiotomyPerineumRandomized controlled trialVaginal delivery

Identifiers

PMID28438209
PMCPMC5402639
OpenAlexW2125471796

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.