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Trial record 1 of 1 for:    NCT03973281
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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

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Shorter Delivery Time [ Time Frame: Assessed during childbirth ]
    The primary effectiveness endpoint is the length of the second stage of labor, defined as the time from the cervix being dilated to 10cm to the complete delivery of the baby.
  • Adverse Events [ Time Frame: Assessed during childbirth to 3-month follow-up ]
    No increase in adverse events or device related adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Reduce Pelvic Muscle Injury [ Time Frame: 3-month follow-up ]
    Rate of pelvic muscle injury defined as either complete separation of the puborectalis muscle, partial separation of the puborectalis muscle, or anal sphincter disruption diagnosed via ultrasound imaging at 3-month follow-up.
  • Reduce Micro-Injuries to Pelvic Muscles [ Time Frame: 3-month follow-up ]
    Maintain the Levator Hiatus Area (measurement between pelvic muscle and pelvic bone) determined at 3-month ultrasound follow-up
  • Shorter Pushing Time [ Time Frame: Assessed during childbirth ]
    Length of Pushing Time, defined as the time from when the mother begins pushing to the complete delivery of the baby.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EASE: The Materna Prep Pivotal Study
Official Title  ICMJE 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
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Childbirth
Intervention  ICMJE
  • Device: Materna Prep Device
    Materna Prep Device
  • Other: Standard of Care (SOC)
    Standard of Care (SCO)
Study Arms  ICMJE
  • Active Comparator: Materna Prep Device
    Materna Prep Device
    Intervention: Device: Materna Prep Device
  • Standard of Care (SOC)
    Standard of Care (SOC)
    Intervention: Other: Standard of Care (SOC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2021)
283
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
200
Estimated Study Completion Date  ICMJE June 22, 2022
Estimated Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hang Nguyen 866-433-6933 hang@maternamed.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973281
Other Study ID Numbers  ICMJE MaternaMedical
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: General demographic data and outcome measures will be made available to other researchers
Responsible Party Materna Medical
Study Sponsor  ICMJE Materna Medical
Collaborators  ICMJE
  • Baylor College of Medicine - Texas Children's Hospital
  • University of Michigan
Investigators  ICMJE Not Provided
PRS Account Materna Medical
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP