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A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Dilate the Vaginal Canal in Preparation for Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT03973281
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Baylor College of Medicine; Texas Children's Hospital, Houston TX; Ben Taub Hospital, Houston, TX; 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 the length of the second stage of labor, and reducing pelvic muscle injuries during vaginal delivery.

Condition or disease Intervention/treatment Phase
Childbirth Problems Pelvic Injury Vaginal Delivery Device: Materna Prep Childbirth Preparation Not Applicable

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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: Prevention
Official Title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Dilate the Vaginal Canal in Preparation for Vaginal Delivery
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
Active Comparator: Materna Prep Device
The group will receive the Materna Prep Device during the 1st stage of labor, during childbirth.
Device: Materna Prep Childbirth Preparation
The goal of the Materna Prep Device is to prepare the pelvic muscles and vaginal canal for a shorter delivery with less injury. The Materna Prep Device is a mechanical dilator that penetrates the first 1/3 - 1/2 of the vaginal canal, or 4-5 cm. The Materna Prep Device gradually expands the vaginal introitus and pelvic tissues from a resting diameter of approximately 3 cm to 8-10 cm, approximately the size of the delivering fetal head.

Sham Comparator: Materna Sham Device
The group will receive a Sham Materna Device during the 1st stage of labor, during childbirth.
Device: Materna Prep Childbirth Preparation
The goal of the Materna Prep Device is to prepare the pelvic muscles and vaginal canal for a shorter delivery with less injury. The Materna Prep Device is a mechanical dilator that penetrates the first 1/3 - 1/2 of the vaginal canal, or 4-5 cm. The Materna Prep Device gradually expands the vaginal introitus and pelvic tissues from a resting diameter of approximately 3 cm to 8-10 cm, approximately the size of the delivering fetal head.




Primary Outcome Measures :
  1. 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.

  2. Adverse Events [ Time Frame: Assessed during childbirth to 3-month follow-up ]
    No increase in adverse events or device related adverse events


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Enrollment will be for women pregnant expecting their first vaginal delivery
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

  1. Subject has high likelihood of less than 1 hour 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.

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 Not yet 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, Houston TX; Ben Taub Hospital, Houston, TX; University of Michigan

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Responsible Party: Materna Medical
ClinicalTrials.gov Identifier: NCT03973281     History of Changes
Other Study ID Numbers: MaternaMedical
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 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
Pediatric Postmarket Surveillance of a Device Product: No

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