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Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.

NCT03683264 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-02-15

No results posted yet for this study

Summary

The main target is to determine levator ani muscle avulsion rate in vacuum delivery, comparing it to forceps delivery. As secondary goals, The aim to evaluate the difference in levator hiatus area among our study groups.

Conditions

  • Birth Injuries
  • Pelvic Floor Disorders
  • Instrumental; Injury, Obstetric

Interventions

OTHER

Ultrasound diagnosis of avulsion of the levator ani muscle

In the multi-view ultrasound images, complete avulsion was defined as an abnormal insertion of LAM in the lower pubic branch identified in all three central slices, i.e. in the plane of minimal hiatal dimensions (PMD) and the 2.5 and 5.0mm slices cranial to this one. Levator hiatus measurements, transverse diameters, anteroposterior diameters and area were also determined in the same plane (PMD).

Sponsors & Collaborators

  • Hospital Universitario de Valme

    lead OTHER

Principal Investigators

  • José Antonio García Mejido · Hospital Universitario de Valme

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-05-01
Completion
2019-06-01

Countries

  • Spain

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 NCT03683264 on ClinicalTrials.gov