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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound diagnosis of avulsion of the levator ani muscle
Sponsored by
Hospital Universitario de Valme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Birth Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Nuestra Señora de ValmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Vacuum delivery

Forceps delivery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2018
Last Updated
February 13, 2019
Sponsor
Hospital Universitario de Valme
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1. Study Identification

Unique Protocol Identification Number
NCT03683264
Brief Title
Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
Official Title
Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Valme

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Injuries, Pelvic Floor Disorders, Instrumental; Injury, Obstetric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vacuum delivery
Arm Type
Other
Arm Description
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.
Arm Title
Forceps delivery
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Ultrasound diagnosis of avulsion of the levator ani muscle
Intervention Description
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 Measure Information:
Title
Compare the rate of levator ani muscle avulsion
Description
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.
Time Frame
at 6 months after randomisation
Title
Compare the levator ani muscle hiatus area (cm2)
Description
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.
Time Frame
at 6 months after randomisation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Antonio García Mejido
Phone
+34955015383
Email
jagmejido@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Antonio García Mejido
Organizational Affiliation
Hospital Universitario de Valme
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Antonio García Mejido
Phone
9055015385
Email
jagmejido@hotmail.com

12. IPD Sharing Statement

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

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