EASE: The Materna Prep Pivotal Study

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.

Detailed Description
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Vaginal delivery is a major risk factor for pelvic floor dysfunction. Clinical aspects of pelvic floor dysfunction include pelvic organ prolapse, sexual dysfunction, and fecal and urinary incontinence. Trauma to the pelvic structures occurs as the fetal head passes through the vaginal canal, especially with acute distension at the time of crowning - the exiting of the fetal head. The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor in order to prepare the vaginal canal for vaginal delivery. By slowly pre-stretching the vagina and surrounding pelvic tissues during labor, the device is essentially dictating the strain rate of the tissue during labor. In previous feasibility studies, the elastic recovery of the tissue has been shown to be on the order of several hours, allowing the benefits of pre-stretching the vagina and surrounding pelvic tissues to last throughout labor. The device is intended to be removed prior to the initiation of the second stage of labor, for delivery to occur unobstructed. The target patient population for this study is nulliparous women entering the first phase of labor and scheduled for vaginal delivery with an epidural.

Official Title
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A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

Conditions
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Vaginal Delivery, Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Materna Prep Device
* Other: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria for inclusion Subject is scheduled for vaginal birth. Subject is gestating a single fetus. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation. Subject is able and willing to comply with the protocol required follow-up visits. Subject is able and willing to provide written informed consent prior to enrollment. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience with the device. Subject receives epidural anesthesia during labor prior to enrollment. Subject is 18 years of age or older at time of consent. Exclusion Criteria: Criteria for exclusion Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital. Subject is planning or requires a Caesarean-section prior to randomization. Subject begins labor with less than 36 weeks gestation. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome. Subject has a localized (genital tract) or systemic infection. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy. Subject has placenta previa or vasa previa. Subject has known significant chromosomal or structural fetal anomalies. Subject has a category 2 and/or 3 fetal tracing that is unresolved. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Materna Prep Device<br>Materna Prep Device | Device: Materna Prep Device<br>* Materna Prep Device<br>|
| Other: Standard of Care (SOC)<br>Standard of Care (SOC) | Other: Standard of Care (SOC)<br>* Standard of Care (SOC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging | Use transperineal ultrasound to identify levator ani muscle detachment | 3-month Follow-up | 
| The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging | Use transperineal ultrasound to identify levator ani muscle detachment | 12-month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging | Use transperineal ultrasound to identify levator ani muscle detachments | 3-Month Follow-up | 
| The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging | Use transperineal ultrasound to identify levator ani muscle detachments | 12-Month Follow-up | 
| Length of 2nd Stage Labor | Compare the length of the second stage of labor, defined as the time from the cervix being dilated to 10 cm to the complete delivery of the baby between study groups. | Intra-Procedure | 
| Levator Hiatal Area | Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone) | 3-month and 12-month Follow-up | 
| Perineal Lacerations | Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups | Intra-Procedure | 
| Obstetric anal sphincter injury - OASI | Compare the rate of tearing of the muscles of the anal sphincter between study groups. | Intra-Procedure | 
| Obstetric anal sphincter injury - OASI | Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups. | 3-month follow-up | 
| C-Sections | Compare the rate of C-Section due to arrest of labot in the second stage | Intra-Procedure | 
| Infant APGAR scores | Compare infant APGAR scores between study groups. A score of 7-10 after 5 minutes is reassuring, a score of 4-6 after minutes is moderately abnormal and a score of 0-3 is concerning. | Intra-Procedure | 
| Qualitative pelvic health feedback | Compare qualitative pelvic health feedback assessed by PFIQ-7 (utilizing 4-point scale representing Not at all to quite a bit) questionnaires from subjects between study groups. | 3-Month and 12-month Follow-up | 
| Qualitative pelvic health feedback | Compare qualitative pelvic health feedback assessed by PFID-20 (Utilizing a 5 point scale with 0=not present to 4=quite a bit) questionnaires from subjects between study groups. | 3-Month and 12-month Follow-up | 
| Qualitative pain | Compare qualitative pain assessed by VAS (0-10, with 0 being No pain and 10 being severe pain) from subjects between study groups | 3-Month and12-month Follow-up | 
| User Satifaction | Satisfaction assessed by a clinician satisfaction questionnaire after device use. | Intra-Procedure | 
| Operative Delivery | Compare the rate of instrument use in vaginal deliveries between study gorups | Intra-Procedure | 
| Types of Perineal Lacerations | Compare rate of the TYPES of perineal lacerations between study groups. | Intra-Procedure | 
| Reasons for C-Sections | Compare incidence of the REASONS for C-Sections between study groups | Intra-Procedure | 
| First Push to Delivery | Compare the mean time form first push to delivery between study groups. | Intra-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention