Vaginal DeliveryNCT03973281
EASE: The Materna Prep Pivotal Study
A study testing Materna Prep Device in people with Vaginal Delivery and Pelvic Organ Prolapse, run by Materna Medical at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Delivery, Pelvic Organ Prolapse
- What is being tested?
- Materna Prep Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 22 sitesUnited States
- Study dates
- 11 Dec 2019to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
The Cooper Health System
Camden, New Jersey, 08103
The Metro Health System
Cleveland, Ohio, 44109
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
New York Presbyterian -Queens (NYPQ)
Flushing, New York, 11355
La Follette Ob/Gyn
Greenbrae, California, 94904
Baylor College of Medicine
Houston, Texas, 77030
The Healing Sanctuary
Idaho Falls, Idaho, 83404
Maximos Ob/Gyn
League City, Texas, 77573
University of California Los Angeles
Los Angeles, California, 90095
El Camino Hospital
Mountain View, California, 94040
Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Columbia University Irving Medical Center
New York, New York, 10032
Christiana Care - Center for Women's & Children's Health
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19140
Lewis Katz School of Medicine at Temple
Philadelphia, Pennsylvania, 19140
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Univ of Utah Ob/Gyn
Salt Lake City, Utah, 84108
USF Ob/Gyn
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this 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
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.
Read the 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.
- Conditions
- Vaginal Delivery, Pelvic Organ Prolapse
- Being tested
- Materna Prep Device, Standard of Care (SOC)
- Keywords
- Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Materna Prep DeviceDevice
Materna Prep Device
Standard of Care (SOC)Other
Standard of Care (SOC)
| Study group | Role | What they receive |
|---|---|---|
| Materna Prep Device | Active comparator | Materna Prep Device Receives: Device: Materna Prep Device |
| Standard of Care (SOC) | Other | Standard of Care (SOC) Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12-month Follow-up
Secondary outcomes (17)
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
Measured: 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
Measured: 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.
Measured: Intra-Procedure
Levator Hiatal Area
Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)
Measured: 3-month and 12-month Follow-up
Perineal Lacerations
Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups
Measured: Intra-Procedure
Obstetric anal sphincter injury - OASI
Compare the rate of tearing of the muscles of the anal sphincter between study groups.
Measured: Intra-Procedure
Obstetric anal sphincter injury - OASI
Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups.
Measured: 3-month follow-up
C-Sections
Compare the rate of C-Section due to arrest of labot in the second stage
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3-Month and12-month Follow-up
User Satifaction
Satisfaction assessed by a clinician satisfaction questionnaire after device use.
Measured: Intra-Procedure
Operative Delivery
Compare the rate of instrument use in vaginal deliveries between study gorups
Measured: Intra-Procedure
Types of Perineal Lacerations
Compare rate of the TYPES of perineal lacerations between study groups.
Measured: Intra-Procedure
Reasons for C-Sections
Compare incidence of the REASONS for C-Sections between study groups
Measured: Intra-Procedure
First Push to Delivery
Compare the mean time form first push to delivery between study groups.
Measured: Intra-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start11 Dec 2019
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materna Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973281
- Sponsor's protocol ID
- MaternaMedical
- Status last verified
- Aug 2026
- First submitted
- 31 May 2019
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: General demographic data and outcome measures will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03973281
- Acronym / sponsor ID
- MaternaMedical
- Conditions
- Vaginal Delivery, Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Materna MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Study
| Arm | Type | Receives |
|---|---|---|
| Materna Prep Device | Active comparator | Device: Materna Prep DeviceMaterna Prep Device |
| Standard of Care (SOC) | Other | Other: Standard of Care (SOC)Standard of Care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Materna Prep DeviceMaterna Prep Device | Device | Materna Prep Device |
| Standard of Care (SOC)Standard of Care (SOC) | Other | Standard of Care (SOC) |
Primary outcome
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
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
17 secondary outcomes
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
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
Length of 2nd Stage Labor
Time frame: Intra-Procedure
Levator Hiatal Area
Time frame: 3-month and 12-month Follow-up
Perineal Lacerations
Time frame: Intra-Procedure
Obstetric anal sphincter injury - OASI
Time frame: Intra-Procedure
Obstetric anal sphincter injury - OASI
Time frame: 3-month follow-up
C-Sections
Time frame: Intra-Procedure
Infant APGAR scores
Time frame: Intra-Procedure
Qualitative pelvic health feedback
Time frame: 3-Month and 12-month Follow-up
Qualitative pelvic health feedback
Time frame: 3-Month and 12-month Follow-up
Qualitative pain
Time frame: 3-Month and12-month Follow-up
User Satifaction
Time frame: Intra-Procedure
Operative Delivery
Time frame: Intra-Procedure
Types of Perineal Lacerations
Time frame: Intra-Procedure
Reasons for C-Sections
Time frame: Intra-Procedure
First Push to Delivery
Time frame: Intra-Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. General demographic data and outcome measures will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Materna Prep Device in people with Vaginal Delivery and Pelvic Organ Prolapse, run by Materna Medical at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.