Materna Prep Study Phase II (EASE)

EASE Study: A Randomized, Controlled Study to EvAluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Muscles in Preparation for Vaginal Delivery

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 3 months from the time of the use of the device during delivery with optional long-term follow-up.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Vaginal Delivery
• Intervention / Treatment: Device: Materna Prep Device

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Mountain View, California, United States, 94040
      • El Camino Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care - Center for Women's & Children's Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson University Hospital
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • The Metro Health System
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Lewis Katz School of Medicine at Temple
    • Philadelphia, Pennsylvania, United States, 19718
      • Hospital of the University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Materna Prep Device	Device: Materna Prep Device; Subjects are treated with Materna Prep Device prior to vaginal delivery
No Intervention: Standard of Care (SOC); Standard of Care Control

What is the study measuring?

Primary 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 imagingmuscle diagnosed via ultrasound imaging	Use transperineal ultrasound to identify levator ani muscle detachment	3-month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levator Hiatal Area	Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)	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	3-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.	Day of Delivery
Perineal Lacerations	Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups	Day of Delivery
Obstetric anal sphincter injury - OASI	Compare the rate of tearing of the muscles of the anal sphincter between study groups.	Day of Delivery
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	Day of Delivery
Infant APGAR scores	Compare infant APGAR scores between study groups.	Day of Delivery
Qualitative pelvic health feedback	Compare qualitative pelvic health feedback assessed by PFIQ-7and PFDI-20 Questionnaires	3-month Follow-up
Operative Delivery	Compare the rate of instrument use in vaginal deliveries between study groups	Day of Delivery
First Push to Delivery	Compare the mean time form first push to delivery between study groups.	Day of Delivery

Collaborators and Investigators

• Sponsor: Materna Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Complications; Childbirth; Vaginal Delivery; Pelvic Floor Health; Levator Ani Muscle Injury; Pelvic Floor Injury
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: CP0001.G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No