Materna Prep Study Phase II

NCT06126328 | Completed Phase 2 FDA Device

• 1 other identifier: CP0001.G
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 15

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 with optional long-term follow-up.

Conditions

Vaginal Delivery; Pelvic Organ Prolapse

Keywords

Pelvic Floor Health; Levator Ani Muscle Injury; Pelvic Floor Injury; Vaginal Delivery; Childbirth; Complications

Outcome Measures

Primary Outcomes (1)

• The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imagingmuscle diagnosed via ultrasound imaging

  Use transperineal ultrasound to identify levator ani muscle detachment

  3-month Follow-up

Secondary Outcomes (11)

• The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging

  3-month Follow-up

• Length of 2nd Stage Labor

  Day of Delivery

• Levator Hiatal Area

  3-month Follow-up

• Perineal Lacerations

  Day of Delivery

• Obstetric anal sphincter injury - OASI

  Day of Delivery

Study Arms (2)

Materna Prep Device

ACTIVE COMPARATOR

Materna Prep Device

Device: Materna Prep Device

Standard of Care (SOC)

NO INTERVENTION

Standard of Care Control

Interventions

Materna Prep Device DEVICE

Subjects are treated with Materna Prep Device prior to vaginal delivery

Materna Prep Device

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is scheduled for vaginal birth.
• Subject is gestating a single fetus.
• Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
• Subject is able and willing to comply with the protocol required follow-up visits.
• Subject is able and willing to provide written informed consent prior to enrollment.
• In the opinion of the Investigator, the 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.
• Subject receives epidural anesthesia during labor prior to enrollment.
• Subject is 18 years of age or older at time of consent.

You may not qualify if:

• Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
• Subject is planning or requires a Caesarean-section prior to randomization.
• Subject begins labor with less than 36 weeks gestation.
• Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
• Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
• Subject has a localized (genital tract) or systemic infection.
• Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
• 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.
• Subject has placenta previa or vasa previa.
• Subject has known significant chromosomal or structural fetal anomalies.
• Subject has a category 2 and/or 3 fetal tracing that is unresolved.

Sponsors & Collaborators

• Materna Medical: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Christiana Care - Center for Women's & Children's Health

Newark, Delaware, 19718, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

Rutgers Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

The Metro Health System

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lewis Katz School of Medicine at Temple

Philadelphia, Pennsylvania, 19140, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19718, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Ultrasound images are assessed by physicians blinded to randomization
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: September 8, 2021
• Primary Completion: March 23, 2023
• Study Completion: October 12, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)