The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)

NCT02356237 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2020-02-05

No results posted yet for this study

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.

Conditions

  • Anal Sphincter Injury

Interventions

OTHER

No episiotomy

Avoidance of episiotomy

Sponsors & Collaborators

  • Bnai Zion Medical Center

    collaborator OTHER_GOV
  • Rambam Health Care Campus

    collaborator OTHER
  • Hillel Yaffe Medical Center

    collaborator OTHER_GOV
  • Ziv Medical Center

    collaborator OTHER
  • The Baruch Padeh Medical Center, Poriya

    collaborator OTHER_GOV
  • Western Galilee Hospital-Nahariya

    collaborator OTHER_GOV
  • Lena Sagi-Dain

    lead OTHER

Principal Investigators

  • Shlomi Sagi, M.D. · Bnai-Zion Medical Center, Haifa, Israel

  • Reuven Keidar, M.D. · Carmel Medical Center, Haifa, Israel

  • Ido Solt, M.D. · Rambam Health Care Campus, Haifa, Israel

  • Asnat Walfisch, M.D. · Hillel Yaffe Medical Center, Hadera, Israel

  • Dmitry Chuyun, M.D. · The Baruch Padeh Medical Center, Poriya, Israel

  • David Peleg, M.D. · Ziv Medical Center, Tzfat, Israel

  • Oleg Shnaider, M.D. · Western Galilee Medical Center, Nahariya, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-05-06
Completion
2018-05-06

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356237 on ClinicalTrials.gov