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

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 : December 26, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
University of Michigan
Information provided by (Responsible Party):
Materna Medical

Study Description
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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:

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

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


Condition or disease Intervention/treatment Phase
Childbirth Device: Materna Prep Device Device: Materna Sham Device Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Official Title: A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth.
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Materna Prep Device
Materna Prep Device
 Device: Materna Prep Device
Materna Prep Device

Device: Materna Sham Device
Materna Sham Device
Active Comparator: Materna Sham Device
Materna Sham Device
 Device: Materna Prep Device
Materna Prep Device

Device: Materna Sham Device
Materna Sham Device


Outcome Measures
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Primary Outcome Measures :
  1. Shorten Length of 2nd Phase of Labor [ Time Frame: Immediate ]
    Shorten Delivery Time

  2. Reduce Pelvic Muscle Injuries [ Time Frame: 3-month Follow-up ]
    Use Ultrasound to diagnose both complete and partial injuries to the pelvic floor muscles


Secondary Outcome Measures :
  1. Reduce Change in Levator Hiatus Area [ Time Frame: 3-month Follow-up ]
    Use ultrasound to measure Levator Hiatus area between device and control groups

  2. Reduce Perineal Lacerations [ Time Frame: Immediate ]
    Reduce the rate of perineal lacerations between device and control groups

  3. Shorten Pushing Time [ Time Frame: Immediate ]
    Shorten the pushing time for delivery


Eligibility Criteria
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Information from the National Library of Medicine

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.


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

Exclusion Criteria:

Criteria for exclusion 1. Subject has high likelihood of less than 2 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 had previous delivery or previous pregnancy progressing beyond 24 weeks gestation 5. Subject has neurological diseases, e.g. Multiple Sclerosis, that may result in unrelated pelvic disorders 6. Subject has muscular or skin disorder that affects elasticity of tissue, such as scleroderma or lupus. 7. Subject has local or systemic infection e.g. HIV, or active herpes infection 8. Subject has any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries 9. 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. 10. Prepregnancy BMI >35

Contacts and Locations
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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: Mark Juravic 4152541031 mark@maternamed.com

Locations
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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
University of Michigan
  Study Documents (Full-Text)

Documents provided by Materna Medical:
Study Protocol and Informed Consent Form  [PDF] December 10, 2019

More Information
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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: December 26, 2019
Last Verified: December 2019
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