EASE: The Materna Prep Pivotal Study
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|ClinicalTrials.gov Identifier: NCT03973281|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : September 29, 2021
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.
- 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 :||283 participants|
|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|
|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|
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
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 Nguyenfirstname.lastname@example.org|
|United States, California|
|University of California Los Angeles||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jenny Lester JLester@mednet.ucla.edu|
|Contact: Ross Divinagracia Rossmar@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, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kara M Rood, MD 404-321-0264 email@example.com|
|Contact: Taryn L Summerfield, MS 614-293-2122 firstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Francisco Orejuela, MD 832-826-7735 Francisco.Orejuela@bcm.edu|