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Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women

NCT02643108 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 717

Last updated 2023-10-04

No results posted yet for this study

Summary

Nulliparous women with a live singleton pregnancy in cephalic presentation past 34 gestational weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal delivery by vacuum extraction is indicated. Primary outcome is clinically diagnosed obstetric anal sphincter injury (OASIS) of any degree.

Conditions

  • Pelvic Floor Disorders
  • Fecal Incontinence
  • Dystocia
  • Fetal Hypoxia

Interventions

PROCEDURE

Lateral episiotomy

When the woman is randomized to episiotomy, lateral episiotomy is performed with scissors on the left or right side of the vaginal opening. Origin of incision is 1.0 - 3.0 cm from the midline/posterior forchette and is cut 3.0 cm or more towards the ischial tuberosity at an angle of 60 degrees from the midline.

Sponsors & Collaborators

Principal Investigators

  • Sophia Brismar Wendel, MD, PhD · Karolinska Institutet Danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2023-02-15
Completion
2028-12-31

Countries

  • Sweden

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 NCT02643108 on ClinicalTrials.gov