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A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth.

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ClinicalTrials.gov Identifier: NCT03973281
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : July 31, 2019
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 July 31, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Shorten Length of 2nd Phase of Labor [ Time Frame: Immediate ]
    Shorten Delivery Time
  • Reduce Pelvic Muscle Injuries [ Time Frame: 3-month Follow-up ]
    Use Ultrasound to diagnose both complete and partial injuries to the pelvic floor muscles
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 Complete list of historical versions of study NCT03973281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
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 A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth.
Official Title  ICMJE A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth.
Brief Summary

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing the length of the second stage of labor and reducing pelvic muscle injuries during vaginal delivery.

Intervention with the Materna Prep Device is expected to be a one-time use of 30-90 minutes. Total subject participation in the study is expected to be up to 4 months from the time of initial enrollment. All evaluations prior to and after delivery can be performed on an outpatient basis. The Materna Prep Device is a vaginal dilator used to pre-stretch the vaginal canal to shorten the length of second stage of labor in preparation for vaginal delivery.

This is randomized, controlled study designed to evaluate safety and effectiveness of the Materna Prep Device in pre-stretching the vaginal canal in preparation for vaginal delivery. 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. 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.

There are three secondary endpoints:

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.

Length of Pushing Time, defined as the time from when the mother begins pushing to the complete delivery of the baby.

Levator Hiatus Area (measurement between pelvic muscle and pelvic bone) determined at 3-month ultrasound follow-up.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Sham Control Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Researchers, patients, and data evaluators will be blinded to the patient's treatment group.
Primary Purpose: Other
Condition  ICMJE Childbirth
Intervention  ICMJE
  • Device: Materna Prep Device
    Materna Prep Device
  • Device: Materna Sham Device
    Materna Sham Device
Study Arms  ICMJE
  • Active Comparator: Materna Prep Device
    Materna Prep Device
    Interventions:
    • Device: Materna Prep Device
    • Device: Materna Sham Device
  • Active Comparator: Materna Sham Device
    Materna Sham Device
    Interventions:
    • Device: Materna Prep Device
    • Device: Materna Sham Device
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria Subject scheduled for vaginal birth. Subject gestating a single fetus. Subject primiparas, or had a previous pregnancy terminated within 24 weeks gestation.

Subject able and willing to comply with the protocol required follow-up visits. Subjects able and willing to provide written informed consent prior to enrollment.

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.

Subjects agrees that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies.

Exclusion Criteria Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital Subject has need for or is planning a Caesarean-section Subject begins labor with less than 36 weeks gestation Subject had previous delivery or previous pregnancy progressing beyond 24 weeks gestation Subject has neurological diseases, e.g. Multiple Sclerosis, that may result in unrelated pelvic disorders Subject has muscular or skin disorder that affects elasticity of tissue, such as scleroderma or lupus.

Subject has local or systemic infection e.g. HIV, or active herpes infection Subject has any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries 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.

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: Mark Juravic 4152541031 mark@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
Pediatric Postmarket Surveillance of a Device Product: No
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 July 2019

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