Vaginal DeliveryPhase 2EASENCT06126328
Materna Prep Study Phase II
A Phase 2 study testing Materna Prep Device in people with Vaginal Delivery and Pelvic Organ Prolapse, run by Materna Medical at 15 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
- 214 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 Sep 2021to 12 Oct 2023
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 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
Baylor College of Medicine
Houston, Texas, 77030
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
Lewis Katz School of Medicine at Temple
Philadelphia, Pennsylvania, 19140
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19718
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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.
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
- Keywords
- Pelvic Floor Health, Levator Ani Muscle Injury, Pelvic Floor Injury, Vaginal Delivery, Childbirth, Complications
- 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
Subjects are treated with Materna Prep Device prior to vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| Materna Prep Device | Active comparator | Materna Prep Device Receives: Device: Materna Prep Device |
| Standard of Care (SOC) | No intervention | Standard of Care Control |
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 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
Measured: 3-month Follow-up
Secondary outcomes (11)
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
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: Day of Delivery
Levator Hiatal Area
Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)
Measured: 3-month Follow-up
Perineal Lacerations
Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups
Measured: Day of Delivery
Obstetric anal sphincter injury - OASI
Compare the rate of tearing of the muscles of the anal sphincter between study groups.
Measured: 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.
Measured: 3-month Follow-up
C-Sections
Compare the rate of C-Section due to arrest of labot in the second stage
Measured: Day of Delivery
Infant APGAR scores
Compare infant APGAR scores between study groups.
Measured: Day of Delivery
Qualitative pelvic health feedback
Compare qualitative pelvic health feedback assessed by PFIQ-7and PFDI-20 Questionnaires
Measured: 3-month Follow-up
Operative Delivery
Compare the rate of instrument use in vaginal deliveries between study groups
Measured: Day of Delivery
First Push to Delivery
Compare the mean time form first push to delivery between study groups.
Measured: Day of Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start8 Sep 2021
- Primary completion23 Mar 2023
- Study completion12 Oct 2023
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materna Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126328
- Sponsor's protocol ID
- CP0001.G
- Acronym
- EASE
- Status last verified
- Feb 2024
- First submitted
- 6 Nov 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06126328
- Acronym / sponsor ID
- EASE / CP0001.G
- Conditions
- Vaginal Delivery, Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Health, Levator Ani Muscle Injury, Pelvic Floor Injury, Vaginal Delivery, Childbirth, Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Materna MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 13 Nov 2023 (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 3 months from the time of the use of the device during delivery with optional long-term follow-up.
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 Trial
| Arm | Type | Receives |
|---|---|---|
| Materna Prep Device | Active comparator | Device: Materna Prep DeviceMaterna Prep Device |
| Standard of Care (SOC) | No intervention | –Standard of Care Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 DeviceSubjects are treated with Materna Prep Device prior to vaginal delivery | Device | Materna Prep Device |
Primary outcome
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
Time frame: 3-month Follow-up
Use transperineal ultrasound to identify levator ani muscle detachment
11 secondary outcomes
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
Length of 2nd Stage Labor
Time frame: Day of Delivery
Levator Hiatal Area
Time frame: 3-month Follow-up
Perineal Lacerations
Time frame: Day of Delivery
Obstetric anal sphincter injury - OASI
Time frame: Day of Delivery
Obstetric anal sphincter injury - OASI
Time frame: 3-month Follow-up
C-Sections
Time frame: Day of Delivery
Infant APGAR scores
Time frame: Day of Delivery
Qualitative pelvic health feedback
Time frame: 3-month Follow-up
Operative Delivery
Time frame: Day of Delivery
First Push to Delivery
Time frame: Day of Delivery
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 5 Feb 2024.
- Individual participant dataSharing planned: No
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Materna Prep Device in people with Vaginal Delivery and Pelvic Organ Prolapse, run by Materna Medical at 15 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 8 inclusion and 11 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 or partial detachment of the levator ani muscle diagnosed via ultrasound imagingmuscle diagnosed via ultrasound imaging (time frame: 3-month Follow-up). 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 5 Feb 2024.