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Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Sponsor: Karolinska Institutet
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.
Official title: Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
717
Start Date
2017-06-30
Completion Date
2028-12
Last Updated
2023-10-04
Healthy Volunteers
No
Interventions
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.
Locations (8)
Falun Hospital
Falun, Sweden
Östra Hospital Gothenburg University
Gothenburg, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Danderyd Hospital
Stockholm, Sweden
South General Hospital
Stockholm, Sweden
Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Växjö Hospital
Vaxjo, Sweden