Evidence map›Paper›PMID 25124938›Full record

Trial reportReproductive health2014

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

Inês Melo, Leila Katz, Isabela Coutinho, Melania Maria Amorim

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Reproductive health, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02178111 (Not Performing Episiotomy Versus Selective Episiotomy), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Selective versus routine use of episiotomy for vaginal birth.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Observational
  8. Article
  9. Article
  10. Once episiotomy, always episiotomy?Archives of gynecology and obstetrics · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Inês Melo
Leila Katz
Isabela Coutinho
Melania Maria AmorimInstituto de Medicina Integral Prof, Fernando Figueira, Recife, PE, Brazil. melania.amorim@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWorld Health Organization (WHO) recommends that the episiotomy rate should be around 10%, which is already a reality in many European countries. Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary. There is no clinical evidence corroborating any indication of episiotomy, so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice.

objectivesTo compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy. METHODS/

designAn open label randomized clinical trial will be conducted including laboring women with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation. Women with bleeding disorders of pregnancy, indication for caesarean section and those without capacity to consent and without legal guardians will be excluded. Primary outcomes will be frequency of episiotomy, delivery duration, frequency of spontaneous lacerations and perineal trauma, frequency of instrumental delivery, 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 frequency complications of perineal suturing, postpartum perineal pain, maternal satisfaction, neonatal morbidity and admission newborn in NICU will be assessed. Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy (experimental group) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery (control Group). The present study was approved by IMIP's Research Ethics Committee.

trial registrationClinical Trials Register under the number and was registered in ClinicalTrials.gov under the number NCT02178111.

Indexed as

Research DesignClinical ProtocolsDelivery, ObstetricEpisiotomyFemaleHumansObstetric Labor ComplicationsPregnancy

Identifiers

PMID25124938
PMCPMC4142063

What OpenQuestion holds

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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.