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

NCT02643108 · tracked via the Priya Life Science Sweden tracker

Sponsor

Karolinska Institutet

Phase

Not applicable

Started

2017-06-30

Last updated

2023-10-04

Condition(s) studied

Pelvic Floor DisordersFecal IncontinenceDystociaFetal Hypoxia

Investigational drug(s) / intervention(s)

Lateral episiotomy

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.

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Nulliparous women,18 years old or more, able to give written informed consent in Swedish or English, with a live singleton pregnancy, in a cephalic presentation over 34 completed gestational weeks with a medical indication for vacuum extraction. Exclusion Criteria: * Previous vaginal or perineal surgery for incontinence or genital prolapse, any contra-indication to vacuum extraction (ie fetal disorder or malformation).

Primary outcome measure(s)

Obstetric anal sphincter injury — 1 hour
Rupture or tear of the external and/or internal anal sphincter at any degree (third and fourth degree perineal tear); International Classification of Diseases (ICD)-10 O70.2 or O70.3.

Trial sites (8)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02643108 on ClinicalTrials.gov ↗ ← All trials in Sweden