Clinical trials: Levator Ani Muscle Injury
Perineal Trauma, Hands-on Technique
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
- Conditions
- Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection
- Trial name
- MPP (NCT07492940)
- Where
- Italy
- Volunteers
- 737 people
- Sponsor
- Azienda ULSS 8 Berica
Labor, Pelvic Floor Disorder
Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome
Pregnancy and vaginal birth are the main causes of pelvic floor disorders such as urinary incontinence and pelvic organ prolapse.
- Conditions
- Labor, Pelvic Floor Disorder, Labor Stage, Second, Induced Labor
- Trial name
- LEVATOR-IOL (NCT07797387)
- Testing
- Three-dimensional transperineal pelvic floor ultrasound
- Where
- Italy
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Roma La Sapienza
Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger…
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Trial name
- NCT05617092
- Testing
- Physiotherapy treatment
- Where
- Sweden
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Vastra Gotaland Region
Prolapse; Female, Prolapse Genital
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.
- Conditions
- Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
- Trial name
- NCT06404931
- Testing
- Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy, Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
- Where
- Spain
- Volunteers
- 90 people
- Sponsor
- Hospital Mutua de Terrassa
Pelvic Floor Disorders
Evaluation of Levator Ani Muscle Injury in Primiparous
pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur .
- Trial name
- ULTRASOUND (NCT04980235)
- Testing
- transperineal 3D ultrasound
- Where
- Egypt
- Volunteers
- 355 people
- Sponsor
- Alexandria University
Trauma
Levator Ani Muscle Avulsion at First Birth of Mexican Women: Randomized Control Trial
Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These damages by palpation and ultrasound of the pelvic floor can be detected.
- Trial name
- NCT02513420
- Testing
- Perineal muscle training
- Where
- Mexico
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Pelvic Floor Injury, Urinary Incontinence
3D Ultrasound in Women With Vacuum or Forceps Deliveries
The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using…
- Conditions
- Pelvic Floor Injury, Urinary Incontinence, Stool Incontinence
- Trial name
- VADUS (NCT01680731)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Rochester
Pelvic Floor Disorders
Platelet Rich Plasma in Levator Ani Muscle Trauma
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
- Trial name
- NCT03021954
- Testing
- Platelet Rich Plasma
- Where
- Indonesia
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Pelvic Floor Dysfunction
Evaluation of Diffusion Tensor Imaging and High Frequency 3D Endovaginal Ultrasound
To assess the feasibility of a novel MRI technique- diffusion tensor imaging with fibre tracking in understanding the anatomy of the pelvic floor and levator ani muscle injury.
- Trial name
- EDITUS (NCT05955664)
- Testing
- MRI indlcuding DTI, Pelvic floor ultrasound.
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical
Birth Injuries, Pelvic Floor Disorders
Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial.
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
- Trial name
- NCT03683264
- Testing
- Ultrasound diagnosis of avulsion of the levator ani muscle
- Where
- Spain
- Volunteers
- 146 people
- Sponsor
- Hospital Universitario de Valme