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

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ClinicalTrials.gov Identifier: NCT03683264
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
José Antonio García Mejido, Hospital Universitario de Valme

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.

Condition or disease Intervention/treatment Phase
Birth Injuries Pelvic Floor Disorders Instrumental; Injury, Obstetric Other: Ultrasound diagnosis of avulsion of the levator ani muscle Not Applicable

Detailed Description:

Nulliparous women who were recruited for an initial evaluation from our maternity unit, Hospital Universitario Virgen de Valme. Participants were recruited prior to instrumentation at delivery and those meeting the inclusion criteria, being randomized into the two study groups (vacuum delivery or forceps delivery).

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 forceps used for the instrumentation was the forceps of Kielland and the vacuum was a metal vacuum (Bird's cup 50 mm, 80 kPa) was used to perform fetal extraction. A suction cup was carefully placed over the flexion point, avoiding caput succedaneum, and rapid negative pressure was applied (over 2 min, until 0.6-0.8 kg/cm2 ). 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.

Obstetric parameters evaluated were: gestational age, labor induction, epidural analgesia, type of instrumentation, duration of second stage of labor, episiotomy and perineal tears. Fetal parameters studied after birth were: fetal sex, weight, head circumference, umbilical artery pH at birth, Apgar test result (at 1 and 5 min), presence of neonatal morbidity (cephalohaematoma, brachial plexus palsy, etc.), admission to neonatology department and neonatal mortality.

The sonographic evaluation was performed six months after delivery and was carried out by a single examiner, with more than five years experience exclusively in obstetric ultrasound, with specific training in 3/4D imaging and blinded to obstetric data relating to the delivery. A 500_ Toshiba Aplio (Toshiba Medical Systems Corp., Tokyo, Japan) ultrasound with an abdominal probe PVT-675MV 3D was used for the assessments. Images were acquired with patients in dorsal lithotomy position, placed on the gynecological examination table and under empty bladder conditions. The transducer was carefully placed on each patient's perineum, applying the minimal possible pressure. Three volume measurements were taken for each patient: at rest, with Valsalva maneuver and with maximum contraction. Then, offline analysis of ultrasound volumes was carried out. Analysis of ultrasound volumes was performed offline.

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : February 1, 2019

Arm Intervention/treatment
Vacuum delivery
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
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
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
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).




Primary Outcome Measures :
  1. Compare the rate of levator ani muscle avulsion [ Time Frame: at 6 months after randomisation ]

    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.


  2. Compare the levator ani muscle hiatus area (cm2) [ Time Frame: at 6 months after randomisation ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancies with severe maternal or fetal pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683264


Contacts
Contact: José Antonio García Mejido +34955015383 jagmejido@hotmail.com

Locations
Spain
Hospital Nuestra Señora de Valme Recruiting
Sevilla, Spain, 41014
Contact: José Antonio García Mejido    9055015385    jagmejido@hotmail.com   
Sponsors and Collaborators
Hospital Universitario de Valme
Investigators
Principal Investigator: José Antonio García Mejido Hospital Universitario de Valme

Responsible Party: José Antonio García Mejido, Principal Investigator, Hospital Universitario de Valme
ClinicalTrials.gov Identifier: NCT03683264     History of Changes
Other Study ID Numbers: Forceps vs vacuum
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Pelvic Floor Disorders
Birth Injuries
Pregnancy Complications
Infant, Newborn, Diseases