The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)
NCT02356237 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 676
Last updated 2020-02-05
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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