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

NCT03683264 | Unknown

• 1 other identifier: Forceps vs vacuum
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Compare the rate of levator ani muscle avulsion

  To compare the rate of levator ani muscle avulsion in vacuum delivery versus the rate of the ate of levator ani muscle avulsion in forceps delivery. The avulsion is studied by 3D transperineal ultrasound, through the multiplanar study, including images at 2.5 mm from the plane of minimal dmensions. Avulsion was defined as the discontinuity of levator ani muscle fibres at their pubic insertion, which were identified in the three central slices of the multiplanar assessment.

  at 6 months after randomisation

• Compare the levator ani muscle hiatus area (cm2)

  To compare the levator ani muscle hiatus area (cm2) in vacuum delivery versus the levator ani muscle hiatus area (cm2) in forceps delivery. Levator hiatal dimensions can be determined on 3D ultrasound by identifying the plane of minimal dimensions, i.e., the plane which contains the minimal distance between the posterior symphyseal margin and the anterior margin of the levator ani loop immediately posterior to the anorectal angle.

  at 6 months after randomisation

Study Arms (2)

Vacuum delivery

OTHER

Deliveries completed using vacuum instrumentation were performed by obstetricians with a minimum of five years' experience in obstetric practice. In terms of analgesia, epidural analgesia was used for intrapartum analgesia. The vacuum was a metal vacuum (Bird's cup 50 mm, 80 kPa) was used to perform fetal extraction. Traction was carried out during contraction, along with maternal push, at a rate of 2-3 tractions per contraction, and without associating Kristeller maneuver. The procedure was abandoned if, after three cup slides or 15 min, fetal extraction had not been successful. Selective episiotomy was carried out in vacuum delivery following Valme's University Hospital clinical practice guideline for instrumental deliveries.

Other: Ultrasound diagnosis of avulsion of the levator ani muscle

Forceps delivery

OTHER

Deliveries completed using forceps instrumentation were performed by obstetricians with a minimum of five years' experience in obstetric practice. In terms of analgesia, epidural analgesia was used for intrapartum analgesia. The forceps used for the instrumentation was the forceps of Kielland. Traction was carried out during contraction, along with maternal push, at a rate of 2-3 tractions per contraction, and without associating Kristeller maneuver. The procedure was abandoned if, after three cup slides or 15 min, fetal extraction had not been successful. Selective episiotomy was carried out in VD following Valme's University Hospital clinical practice guideline for instrumental deliveries.

Other: Ultrasound diagnosis of avulsion of the levator ani muscle

Interventions

Ultrasound diagnosis of avulsion of the levator ani muscle OTHER

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).

Forceps delivery; Vacuum delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Delivery with forceps or vacuum
• Cephalic presentation
• Primiparity
• At term gestation (37-42 weeks)
• No prior pelvic floor corrective surgery
• Written informed consent

You may not qualify if:

• Pregnancies with severe maternal or fetal pathology

Sponsors & Collaborators

• Hospital Universitario de Valme: lead

Study Sites (1)

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

RECRUITING

MeSH Terms

Conditions

Birth Injuries; Pelvic Floor Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• José Antonio García Mejido

  Hospital Universitario de Valme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Antonio García Mejido

CONTACT

+34955015383; jagmejido@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: September 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

ES (1)