NCT02356237

Brief Summary

This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular hospital), while the other half will not undergo epitiotomy at all. Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated between these two groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

February 1, 2015

Last Update Submit

February 2, 2020

Conditions

Anal Sphincter Injury

Keywords

EpisiotomyObstetric Anal Sphincter Injury

Outcome Measures

Primary Outcomes (1)

  • Obstetric Anal Sphincter injury

    Advanced (3rd and 4th degree) perineal tears, i.e. perineal lacerations involving the anal sphincter, diagnosed by a senior obstetrician

    From the delivery to one hour after delivery

Secondary Outcomes (13)

  • 1st and 2nd degree perineal tears

    From the delivery to one hour after delivery

  • Duration of the second stage of labor

    From beginning of full dilatation to the delivery of the baby

  • Postpartum hemorrhage

    From delivery to one hour postpartum

  • Neonatal Apgar score

    From the delivery to five minutes after delivery

  • Cord blood pH

    From the delivery to first two minutes after delivery

  • +8 more secondary outcomes

Study Arms (2)

No episiotomy

EXPERIMENTAL

Episiotomy will not be performed in this group. Deviation from protocol (i.e. episiotomy performance) will be allowed only according to the discretion of obstetrician in charge of the delivery, in cases of unequivocal benefit to the fetus.

Other: No episiotomy

Selective episiotomy

NO INTERVENTION

The decision to perform episiotomy in this group will be based on routine delivery care, i.e. indistinguishable from any other delivery not participating in the trial.

Interventions

No episiotomyOTHER

Avoidance of episiotomy

No episiotomy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women in labor, or women scheduled for induction of labor, or women attending for a routine follow-up examination during third trimester of pregnancy.
  • First vaginal delivery
  • Singleton pregnancy above 34 gestational weeks
  • Vertex presentation
  • Women who are able to understand and sign the informed consent forms.

You may not qualify if:

  • Absolute contraindications for vaginal delivery (e.g. placenta previa, fetal macrosomia above 4.5 kg, genital herpes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

Related Publications (3)

  • Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD000081. doi: 10.1002/14651858.CD000081.pub2.

    PMID: 19160176BACKGROUND

  • Pergialiotis V, Vlachos D, Protopapas A, Pappa K, Vlachos G. Risk factors for severe perineal lacerations during childbirth. Int J Gynaecol Obstet. 2014 Apr;125(1):6-14. doi: 10.1016/j.ijgo.2013.09.034. Epub 2014 Jan 9.

    PMID: 24529800BACKGROUND

  • Sagi-Dain L, Kreinin-Bleicher I, Bahous R, Gur Arye N, Shema T, Eshel A, Caspin O, Gonen R, Sagi S. Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL). Int Urogynecol J. 2020 Nov;31(11):2377-2385. doi: 10.1007/s00192-020-04332-2. Epub 2020 May 24.

    PMID: 32448935DERIVED

Study Officials

  • Shlomi Sagi, M.D.

    Bnai-Zion Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

  • Reuven Keidar, M.D.

    Carmel Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

  • Ido Solt, M.D.

    Rambam Health Care Campus, Haifa, Israel

    PRINCIPAL INVESTIGATOR

  • Asnat Walfisch, M.D.

    Hillel Yaffe Medical Center, Hadera, Israel

    PRINCIPAL INVESTIGATOR

  • Dmitry Chuyun, M.D.

    The Baruch Padeh Medical Center, Poriya, Israel

    PRINCIPAL INVESTIGATOR

  • David Peleg, M.D.

    Ziv Medical Center, Tzfat, Israel

    PRINCIPAL INVESTIGATOR

  • Oleg Shnaider, M.D.

    Western Galilee Medical Center, Nahariya, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Obstetrician, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 5, 2015

Study Start

June 1, 2015

Primary Completion

May 6, 2018

Study Completion

May 6, 2018

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)