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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 : Unknown
Verified February 2019 by José Antonio García Mejido, Hospital Universitario de Valme.
Recruitment status was:  Recruiting
First Posted : September 25, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
José Antonio García Mejido, Hospital Universitario de Valme

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE September 25, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
Official Title  ICMJE Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Birth Injuries
  • Pelvic Floor Disorders
  • Instrumental; Injury, Obstetric
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Other: Ultrasound diagnosis of avulsion of the levator ani muscle
  • 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.
    Intervention: Other: Ultrasound diagnosis of avulsion of the levator ani muscle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2018)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03683264
Other Study ID Numbers  ICMJE Forceps vs vacuum
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party José Antonio García Mejido, Hospital Universitario de Valme
Original Responsible Party José Antonio García Mejido, Hospital Universitario de Valme, Dr.
Current Study Sponsor  ICMJE Hospital Universitario de Valme
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José Antonio García Mejido Hospital Universitario de Valme
PRS Account Hospital Universitario de Valme
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP