EASE: The Materna Prep Pivotal Study

October 17, 2023 updated by: Materna Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tammy Grisales, MD
      • Mountain View, California, United States, 94040
        • Active, not recruiting
        • El Camino Hospital
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care - Center for Women's & Children's Health
        • Contact:
        • Principal Investigator:
          • Matthew Hoffman, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson University Hospital
        • Principal Investigator:
          • Todd Rosen, MD
        • Contact:
        • Contact:
      • Newark, New Jersey, United States, 07103
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Ju Sheen, MD
    • Ohio
      • Cleveland, Ohio, United States, 44109
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Terminated
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Eileen Wang, MD
      • Philadelphia, Pennsylvania, United States, 19140
        • Active, not recruiting
        • Lewis Katz School of Medicine at Temple
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Materna Prep Device
Device: Materna Prep Device
Materna Prep Device
Other: Standard of Care (SOC)
Other: Standard of Care (SOC)
Standard of Care (SOC)

What is the study measuring?

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
Time Frame: 3-month Follow-up
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
Time Frame: 12-month Follow-up
Use transperineal ultrasound to identify levator ani muscle detachment
12-month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of 2nd Stage Labor
Time Frame: Intra-Procedure
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
Perineal Lacerations
Time Frame: Intra-Procedure
Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups
Intra-Procedure
Obstetric anal sphincter injury - OASI
Time Frame: Intra-Procedure
Compare the rate of tearing of the muscles of the anal sphincter between study groups.
Intra-Procedure
C-Sections
Time Frame: Intra-Procedure
Compare the rate of C-Section due to arrest of labot in the second stage
Intra-Procedure
Infant APGAR scores
Time Frame: Intra-Procedure
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
Operative Delivery
Time Frame: Intra-Procedure
Compare the rate of instrument use in vaginal deliveries between study gorups
Intra-Procedure
Types of Perineal Lacerations
Time Frame: Intra-Procedure
Compare rate of the TYPES of perineal lacerations between study groups.
Intra-Procedure
Reasons for C-Sections
Time Frame: Intra-Procedure
Compare incidence of the REASONS for C-Sections between study groups
Intra-Procedure
First Push to Delivery
Time Frame: Intra-Procedure
Compare the mean time form first push to delivery between study groups.
Intra-Procedure
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
Time Frame: 3-Month Follow-up
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
Time Frame: 12-Month Follow-up
Use transperineal ultrasound to identify levator ani muscle detachments
12-Month Follow-up
Levator Hiatal Area
Time Frame: 3-month and 12-month Follow-up
Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)
3-month and 12-month Follow-up
Obstetric anal sphincter injury - OASI
Time Frame: 3-month follow-up
Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups.
3-month follow-up
Qualitative pelvic health feedback
Time Frame: 3-Month and 12-month Follow-up
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
Time Frame: 3-Month and 12-month Follow-up
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
Time Frame: 3-Month and12-month Follow-up
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
Time Frame: Intra-Procedure
Satisfaction assessed by a clinician satisfaction questionnaire after device use.
Intra-Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materna Medical

Collaborators

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaternaMedical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

General demographic data and outcome measures will be made available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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