Evidence map›Paper›PMID 32448935›Full record

Trial reportInternational urogynecology journal2020

Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL).

Lena Sagi-Dain, Inna Kreinin-Bleicher, Rabia Bahous, Noga Gur Arye, Tamar Shema, Aya Eshel, Orna Caspin, Ron Gonen, Shlomi Sagi

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in International urogynecology journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02356237 (The Effect of Episiotomy on Advanced Perineal Tears and Other Maternal and Fetal Outcomes - Randomized Controlled Multicentric Trial), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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.

NCT02356237 naterminatednot on this map

The Effect of Episiotomy on Advanced Perineal Tears and Other Maternal and Fetal Outcomes - Randomized Controlled Multicentric Trial (EPITRIAL)

TypeinterventionalSponsorLena Sagi-DainRan2015 to 2018Enrolled676ConditionsAnal Sphincter InjuryArmsNo episiotomy
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Trigonometric characteristics of episiotomy & pregnancy variables.European journal of obstetrics & gynecology and reproductive biology: X · 2025
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Lena Sagi-DainDepartment of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel. lena2303@gmail.com.ORCID http://orcid.org/0000-0002-0883-2130
Inna Kreinin-BleicherDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Rabia BahousDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Noga Gur AryeDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Tamar ShemaDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Aya EshelDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Orna CaspinDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Ron GonenThe Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Shlomi SagiDepartment of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears.

methodsIn this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into "avoidance of episiotomy" (the study group in which episiotomy was allowed only in cases of fetal distress) or "standard care." The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears.

resultsThe participants were randomized into "standard care" (n = 337) vs. "no episiotomy" (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17-1.50) in favor of the "no episiotomy" group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126).

conclusionsSince decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237.

Indexed as

LacerationsObstetric Labor ComplicationsEpisiotomyFemaleHumansIncidenceOdds RatioPerineumPregnancyAdvanced perineal tearsEpisiotomy

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.