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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
Sponsor:
Collaborators:
Baylor College of Medicine - Texas Children's Hospital
University of Michigan
Information provided by (Responsible Party):
Materna Medical

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 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

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 283 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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reduction in the length of second stage of labor [ Time Frame: Intra-Procedure ]
    Shorten the pushing time for delivery

  2. 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

  3. Reduce Perineal Lacerations [ Time Frame: Intra-Procedure ]
    Reduce the rate of perineal lacerations between device and control groups

  4. Reduction in the rate of instrument use in vaginal deliveries [ Time Frame: Intra-Procedure ]
    Reduce use of instrument during deliveries

  5. Reduction in the rate of OASI [ Time Frame: Intra-Procedure ]
    Reduce the tearing of the muscles of the anal sphincter

  6. Reduction of C-Sections due to cephalopevic disproportion [ Time Frame: Intra-Procedure ]
    Reduce the rate of C-Sections

  7. Infant APGAR scores [ Time Frame: Intra-Procedure ]
    Increase APGAR scores

  8. Qualitative pain and pelvic health feedback [ Time Frame: 3-Month Follow-up ]
    Reduce pain and pelvic injury

  9. User Satifaction [ Time Frame: 3-Month Follow-up ]
    Obtain positive user satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
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Contact: Hang Nguyen 866-433-6933 hang@maternamed.com

Locations
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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    kara.rood@osumc.edu   
Contact: Taryn L Summerfield, MS    614-293-2122    taryn.summerfield@osumc.edu   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Francisco Orejuela, MD    832-826-7735    Francisco.Orejuela@bcm.edu   
Sponsors and Collaborators
Materna Medical
Baylor College of Medicine - Texas Children's Hospital
University of Michigan
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Responsible Party: Materna Medical
ClinicalTrials.gov Identifier: NCT03973281    
Other Study ID Numbers: MaternaMedical
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
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

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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
Keywords provided by Materna Medical:
Shorten Delivery Time, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention