EASE: The Materna Prep Pivotal Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03973281 |
Recruitment Status :
Recruiting
First Posted : June 4, 2019
Last Update Posted : March 31, 2022
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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. Subjects who elect to continue participation in the long term follow up portion of the study will extend their time in the study to 10 years.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Childbirth | Device: Materna Prep Device Other: Standard of Care (SOC) | Not Applicable |
Primary effectiveness endpoint: Reduction in the rate of pelvic muscle injury defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging at 3-month follow-up.
Primary safety endpoint: Data on maternal and neonatal adverse events will be gathered and evaluated. Adverse events will be further summarized by relatedness to the device and/or procedure, seriousness, and level of severity.
Secondary endpoints
- Reduction in the length of second stage of labor, defined as the time from when the cervix is dilated to 10cm to the complete delivery of the baby.
- Reduction in Levator Hiatus Area (measurement between pelvic muscle and pelvic bone) determined at 3-month ultrasound follow-up.
- Reduction in the rate of perineal lacerations determined by visual inspection post-delivery.
- Reduction in the rate of instrument use in vaginal deliveries.
- Reduction in the rate of OASI
- Rate of C-Sections due to cephalopelvic disproportion.
- Infant APGAR scores.
- Qualitative pain and pelvic health feedback.
- User satisfaction
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 212 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized Control Study |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The physician reading all ultrasound images will be blinded to randomization |
Primary Purpose: | Other |
Official Title: | A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch (i.e., Dilate) the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery |
Actual Study Start Date : | December 11, 2019 |
Estimated Primary Completion Date : | June 22, 2022 |
Estimated Study Completion Date : | June 22, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Materna Prep Device
Materna Prep Device
|
Device: Materna Prep Device
Materna Prep Device |
Standard of Care (SOC)
Standard of Care (SOC)
|
Other: Standard of Care (SOC)
Standard of Care (SCO) |
- Reduction in the rate of pelvic muscle injury defined as complete or partial detachment of the levator ani muscle [ Time Frame: 3-month Follow-up ]Use ultrasound to measure Levator Hiatus defect and Levator Urethral Gap between device and control groups
- Reduction in the length of second stage of labor [ Time Frame: Intra-Procedure ]Shorten the pushing time for delivery
- Reduction in Levator Hiatus Area [ Time Frame: 3-month Follow-up ]Reduce the rate of perineal lacerations between device and control groups determined at 3-month ultrasound follow up
- Reduce Perineal Lacerations [ Time Frame: Intra-Procedure ]Reduce the rate of perineal lacerations between device and control groups
- Reduction in the rate of instrument use in vaginal deliveries [ Time Frame: Intra-Procedure ]Reduce use of instrument during deliveries
- Reduction in the rate of OASI [ Time Frame: Intra-Procedure ]Reduce the tearing of the muscles of the anal sphincter
- Reduction of C-Sections due to cephalopevic disproportion [ Time Frame: Intra-Procedure ]Reduce the rate of C-Sections
- Infant APGAR scores [ Time Frame: Intra-Procedure ]Increase APGAR scores
- Qualitative pain and pelvic health feedback [ Time Frame: 3-Month Follow-up ]Reduce pain and pelvic injury
- User Satifaction [ Time Frame: 3-Month Follow-up ]Obtain positive user satisfaction

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973281
Contact: Hang Nguyen | 866-433-6933 | hang@maternamed.com |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Nancy Saxon nbsaxon@uabmc.edu | |
Contact: Brian Casey, MD 205-934-6638 bcasey@uabmc.edu | |
Principal Investigator: Brian Casey, MD | |
United States, California | |
University of California Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Jenny Lester 310-794-9728 JLester@mednet.ucla.edu | |
Contact: Dana Levin-Lopez 310-794-8893 dlevinlopez@mednet.ucla.edu | |
Principal Investigator: Tammy Grisales, MD | |
El Camino Hospital | Recruiting |
Mountain View, California, United States, 94040 | |
Contact: Michell Backer Michelle_Backer@elcaminohealth.org | |
Contact: Divya Patel, MA Divya@elcaminowomen.com | |
Principal Investigator: Sarah Azad, MD | |
Sub-Investigator: Amy Teng, DO | |
Sub-Investigator: Erika Balassiano, MD | |
Sub-Investigator: Pooja Gupta, MD | |
United States, Delaware | |
Christiana Care - Center for Women's & Children's Health | Recruiting |
Newark, Delaware, United States, 19718 | |
Contact: Carrie Kitto 302-301-2379 ckitto@christianacare.org | |
Principal Investigator: Matthew Hoffman, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Emily Smith smith.emily3@mayo.edu | |
Contact: David Burnette burnette.david@mayo.edu | |
Principal Investigator: Vanessa Torbenson, MD | |
United States, New Jersey | |
The Cooper Health System | Recruiting |
Camden, New Jersey, United States, 08103 | |
Contact: Rori Dajao, MD 215-971-6042 dajao-rori@cooperhealth.edu | |
Contact: Alexander Santangelo 856-342-2473 santangelo-alexander@cooperhealth.edu | |
Principal Investigator: Rori Dajao, MD | |
Rutgers Robert Wood Johnson University Hospital | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Priscila De La Rosa pip168@rwjms.rutgers.edu | |
Contact: Todd Rosen, MD 732-235-6632 todd.rosen@rutgers.edu | |
Principal Investigator: Todd Rosen, MD | |
Rutgers New Jersey Medical School | Recruiting |
Newark, New Jersey, United States, 07103 | |
Contact: Shauna Williams, MD williash@njms.rutgers.edu | |
Contact: Yanille Tavaras 973-972-6262 tavaraya@njms.rutgers.edu | |
Principal Investigator: Shauna Williams | |
United States, New York | |
Columbia University Irving Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Casandra Almonte ca2344@cumc.columbia.edu | |
Contact: Jean-Ju Sheen, MD 212-305-6293 js4596@cumc.columbia.edu | |
Principal Investigator: Jean-Ju Sheen, MD | |
United States, Ohio | |
The Metro Health System | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Wendy Dalton wdalton@metrohealth.org | |
Contact: Kelly Gibson, MD 2677787076 kgibson@metrohealth.org | |
Principal Investigator: Kelly Gibson, MD | |
The Ohio State University Wexner Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Kara M Rood, MD 404-321-0264 kara.rood@osumc.edu | |
Contact: Taryn L Summerfield, MS 614-293-2122 taryn.summerfield@osumc.edu | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Monica Rincon, MD 503-494-8748 rincon@ohsu.edu | |
Contact: Melissa Bollen bollen@ohsu.edu | |
Principal Investigator: Karen Gibbins, MD | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Meaghan McCabe 973-747-2824 meaghan.mccabe@pennmedicine.upenn.edu | |
Principal Investigator: Eileen Wang, MD | |
Lewis Katz School of Medicine at Temple | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Sarmina Hassan, PhD 215-707-7278 sarmina.hassan@tuhs.temple.edu | |
Contact: Laura Hart, MD 215-707-1648 laura.hart@tuhs.temple.edu | |
Principal Investigator: Laura Hart, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Francisco Orejuela, MD 832-826-7735 Francisco.Orejuela@bcm.edu | |
Contact: Christina Stewart Christina.stewart@bcm.edu | |
Principal Investigator: Francisco Orejuela, MD |
Responsible Party: | Materna Medical |
ClinicalTrials.gov Identifier: | NCT03973281 |
Other Study ID Numbers: |
MaternaMedical |
First Posted: | June 4, 2019 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | General demographic data and outcome measures will be made available to other researchers |
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 |
Shorten Delivery Time, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention |