Clinical trial NCT03973281: EASE: The Materna Prep Pivotal Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Delivery
Pelvic Organ Prolapse
Keywords: Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention
Lead sponsor: Materna Medical
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2019-06-04
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Study
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

Criteria for inclusion

1. Subject is scheduled for vaginal birth.
2. Subject is gestating a single fetus.
3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
4. Subject is able and willing to comply with the protocol required follow-up visits.
5. Subject is able and willing to provide written informed consent prior to enrollment.
6. 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.
7. Subject receives epidural anesthesia during labor prior to enrollment.
8. Subject is 18 years of age or older at time of consent.

Exclusion Criteria:

Criteria for exclusion

1. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
2. Subject is planning or requires a Caesarean-section prior to randomization.
3. Subject begins labor with less than 36 weeks gestation.
4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
6. Subject has a localized (genital tract) or systemic infection.
7. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
8. 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.
9. Subject has placenta previa or vasa previa.
10. Subject has known significant chromosomal or structural fetal anomalies.
11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.
12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.

Primary outcomes:
measure: The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
timeFrame: 3-month Follow-up
measure: The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
timeFrame: 12-month Follow-up
Secondary outcomes:
measure: The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
timeFrame: 3-Month Follow-up
measure: The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
timeFrame: 12-Month Follow-up
measure: Length of 2nd Stage Labor
timeFrame: Intra-Procedure
measure: Levator Hiatal Area
timeFrame: 3-month and 12-month Follow-up
measure: Perineal Lacerations
timeFrame: Intra-Procedure
measure: Obstetric anal sphincter injury - OASI
timeFrame: Intra-Procedure
measure: Obstetric anal sphincter injury - OASI
timeFrame: 3-month follow-up
measure: C-Sections
timeFrame: Intra-Procedure
measure: Infant APGAR scores
timeFrame: Intra-Procedure
measure: Qualitative pelvic health feedback
timeFrame: 3-Month and 12-month Follow-up
measure: Qualitative pelvic health feedback
timeFrame: 3-Month and 12-month Follow-up
measure: Qualitative pain
timeFrame: 3-Month and12-month Follow-up
measure: User Satifaction
timeFrame: Intra-Procedure
measure: Operative Delivery
timeFrame: Intra-Procedure
measure: Types of Perineal Lacerations
timeFrame: Intra-Procedure
measure: Reasons for C-Sections
timeFrame: Intra-Procedure
measure: First Push to Delivery
timeFrame: Intra-Procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Newark
country: United States
facility: Christiana Care - Center for Women's & Children's Health
state: Delaware
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson University Hospital
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Cleveland
country: United States
facility: The Metro Health System
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: