Back to resultsEASE: The Materna Prep Pivotal Study
Primary Purpose
Vaginal Delivery, Pelvic Organ Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Materna Prep Device
Standard of Care (SOC)
Sponsored by
About this trial
This is an interventional other trial for Vaginal Delivery focused on measuring Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention
Eligibility Criteria
Inclusion Criteria:
Criteria for inclusion 1. Subject scheduled for vaginal birth. 2. Subject gestating a single fetus. 3. Subject nulliparous, or had a previous pregnancy terminated within 24 weeks gestation. 4. Subject able and willing to comply with the protocol required follow-up visits. 5. Subjects able and willing to provide written informed consent prior to enrollment. 6. 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 using the device. 8. Subject 18 years of age or older at time of consent.
Exclusion Criteria:
Criteria for exclusion 1. Subject has high likelihood of less than 1 hours of potential device dilation time after she arrives at the hospital 2. Subject has need for or is planning a Caesarean-section 3. Subject begins labor with less than 36 weeks gestation 4. Subject has neurological diseases, e.g. Multiple Sclerosis, that may result in unrelated pelvic disorders or has been diagnosed with HIV. 5. Subject has muscular or skin disorder that affects elasticity of tissue, such as scleroderma or lupus.6. Subject has evidence of local or systemic infection, or has active herpes infection. 7. Subject has any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. 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. Known significant chromosomal or structural fetal anomalies 11. Category 2 and/or 3 fetal tracing that is unresolved
Sites / Locations
- University of Alabama at Birmingham
- University of California Los AngelesRecruiting
- El Camino Hospital
- Christiana Care - Center for Women's & Children's HealthRecruiting
- Mayo Clinic
- The Cooper Health SystemRecruiting
- Rutgers Robert Wood Johnson University HospitalRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Columbia University Irving Medical CenterRecruiting
- The Metro Health SystemRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- Oregon Health and Science University
- Hospital of the University of PennsylvaniaRecruiting
- Lewis Katz School of Medicine at Temple
- Baylor College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Materna Prep Device
Standard of Care (SOC)
Arm Description
Materna Prep Device
Standard of Care (SOC)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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.
Levator Hiatal Area
Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)
Perineal Lacerations
Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups
Obstetric anal sphincter injury - OASI
Compare the rate of tearing of the muscles of the anal sphincter between study groups.
Obstetric anal sphincter injury - OASI
Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups.
C-Sections
Compare the rate of C-Section due to arrest of labot in the second stage
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.
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.
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.
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
User Satifaction
Satisfaction assessed by a clinician satisfaction questionnaire after device use.
Operative Delivery
Compare the rate of instrument use in vaginal deliveries between study gorups
Types of Perineal Lacerations
Compare rate of the TYPES of perineal lacerations between study groups.
Reasons for C-Sections
Compare incidence of the REASONS for C-Sections between study groups
First Push to Delivery
Compare the mean time form first push to delivery between study groups.
Full Information
NCT ID
NCT03973281
First Posted
May 31, 2019
Last Updated
October 17, 2023
Sponsor
Materna Medical
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03973281
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materna Medical
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Delivery, Pelvic Organ Prolapse
Keywords
Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Study
Masking
Outcomes Assessor
Masking Description
The physician reading all ultrasound images will be blinded to randomization
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Materna Prep Device
Arm Type
Active Comparator
Arm Description
Materna Prep Device
Arm Title
Standard of Care (SOC)
Arm Type
Other
Arm Description
Standard of Care (SOC)
Intervention Type
Device
Intervention Name(s)
Materna Prep Device
Intervention Description
Materna Prep Device
Intervention Type
Other
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
Standard of Care (SOC)
Primary Outcome Measure Information:
Title
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Description
Use transperineal ultrasound to identify levator ani muscle detachment
Time Frame
3-month Follow-up
Title
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Description
Use transperineal ultrasound to identify levator ani muscle detachment
Time Frame
12-month Follow-up
Secondary Outcome Measure Information:
Title
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
Description
Use transperineal ultrasound to identify levator ani muscle detachments
Time Frame
3-Month Follow-up
Title
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
Description
Use transperineal ultrasound to identify levator ani muscle detachments
Time Frame
12-Month Follow-up
Title
Length of 2nd Stage Labor
Description
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.
Time Frame
Intra-Procedure
Title
Levator Hiatal Area
Description
Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)
Time Frame
3-month and 12-month Follow-up
Title
Perineal Lacerations
Description
Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups
Time Frame
Intra-Procedure
Title
Obstetric anal sphincter injury - OASI
Description
Compare the rate of tearing of the muscles of the anal sphincter between study groups.
Time Frame
Intra-Procedure
Title
Obstetric anal sphincter injury - OASI
Description
Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups.
Time Frame
3-month follow-up
Title
C-Sections
Description
Compare the rate of C-Section due to arrest of labot in the second stage
Time Frame
Intra-Procedure
Title
Infant APGAR scores
Description
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.
Time Frame
Intra-Procedure
Title
Qualitative pelvic health feedback
Description
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.
Time Frame
3-Month and 12-month Follow-up
Title
Qualitative pelvic health feedback
Description
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.
Time Frame
3-Month and 12-month Follow-up
Title
Qualitative pain
Description
Compare qualitative pain assessed by VAS (0-10, with 0 being No pain and 10 being severe pain) from subjects between study groups
Time Frame
3-Month and12-month Follow-up
Title
User Satifaction
Description
Satisfaction assessed by a clinician satisfaction questionnaire after device use.
Time Frame
Intra-Procedure
Title
Operative Delivery
Description
Compare the rate of instrument use in vaginal deliveries between study gorups
Time Frame
Intra-Procedure
Title
Types of Perineal Lacerations
Description
Compare rate of the TYPES of perineal lacerations between study groups.
Time Frame
Intra-Procedure
Title
Reasons for C-Sections
Description
Compare incidence of the REASONS for C-Sections between study groups
Time Frame
Intra-Procedure
Title
First Push to Delivery
Description
Compare the mean time form first push to delivery between study groups.
Time Frame
Intra-Procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josh Freeman
Phone
866-433-6933
Email
clinical@maternamed.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Lester
Phone
310-794-9728
Email
JLester@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Dana Levin-Lopez
Phone
310-794-8893
Email
dlevinlopez@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Tammy Grisales, MD
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Christiana Care - Center for Women's & Children's Health
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Kitto
Phone
302-301-2379
Email
ckitto@christianacare.org
First Name & Middle Initial & Last Name & Degree
Matthew Hoffman, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rori Dajao, MD
Phone
215-971-6042
Email
dajao-rori@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Alexander Santangelo
Phone
856-342-2473
Email
santangelo-alexander@cooperhealth.edu
First Name & Middle Initial & Last Name & Degree
Rori Dajao, MD
Facility Name
Rutgers Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscila De La Rosa
Email
pip168@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Todd Rosen, MD
Phone
732-235-6632
Email
todd.rosen@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Todd Rosen, MD
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauna Williams, MD
Email
williash@njms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Yanille Tavaras
Phone
973-972-6262
Email
tavaraya@njms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Shauna Williams
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casandra Almonte
Email
ca2344@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jean-Ju Sheen, MD
Phone
212-305-6293
Email
js4596@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jean-Ju Sheen, MD
Facility Name
The Metro Health System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Dalton
Email
wdalton@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Kelly Gibson, MD
Phone
2677787076
Email
kgibson@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Kelly Gibson, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara M Rood, MD
Phone
404-321-0264
Email
kara.rood@osumc.edu
First Name & Middle Initial & Last Name & Degree
Taryn L Summerfield, MS
Phone
614-293-2122
Email
taryn.summerfield@osumc.edu
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Terminated
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meaghan McCabe
Phone
973-747-2824
Email
meaghan.mccabe@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Eileen Wang, MD
Facility Name
Lewis Katz School of Medicine at Temple
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Orejuela, MD
Phone
832-826-7735
Email
Francisco.Orejuela@bcm.edu
First Name & Middle Initial & Last Name & Degree
Christina Stewart
Email
Christina.stewart@bcm.edu
First Name & Middle Initial & Last Name & Degree
Francisco Orejuela, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
General demographic data and outcome measures will be made available to other researchers
Learn more about this trial
EASE: The Materna Prep Pivotal Study
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