Materna Prep Study Phase II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2023-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EASE: The Materna Prep Pivotal Study

NCT03973281

Vaginal Delivery Pelvic Organ Prolapse

ACTIVE_NOT_RECRUITING NA

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

NCT06698185

Childbirth

WITHDRAWN NA

A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device

NCT02332759

Tear, Pelvic Organ, Obstetric Trauma

COMPLETED NA

Perineal Massage Using A Pelvic Wand During Pregnancy

NCT06986824

NOT_YET_RECRUITING PHASE4

Vaginal Pessary Versus Expectant Management for Placenta Previa

NCT01996345

Placenta Previa

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vaginal delivery is a major risk factor for pelvic floor dysfunction. Clinical aspects of pelvic floor dysfunction include pelvic organ prolapse, sexual dysfunction, and fecal and urinary incontinence. Trauma to the pelvic structures occurs as the fetal head passes through the vaginal canal, especially with acute distension at the time of crowning - the exiting of the fetal head.

The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor in order to prepare the vaginal canal for vaginal delivery. By slowly pre-stretching the vagina and surrounding pelvic tissues during labor, the device is essentially dictating the strain rate of the tissue during labor. In previous feasibility studies, the elastic recovery of the tissue has been shown to be on the order of several hours, allowing the benefits of pre-stretching the vagina and surrounding pelvic tissues to last throughout labor. The device is intended to be removed prior to the initiation of the second stage of labor, for delivery to occur unobstructed.

The target patient population for this study is nulliparous women entering the first phase of labor and scheduled for vaginal delivery with an epidural.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Delivery Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Ultrasound images are assessed by physicians blinded to randomization

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Materna Prep Device

Group Type ACTIVE_COMPARATOR

Materna Prep Device

Intervention Type DEVICE

Subjects are treated with Materna Prep Device prior to vaginal delivery

Standard of Care (SOC)

Standard of Care Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Materna Prep Device

Subjects are treated with Materna Prep Device prior to vaginal delivery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is scheduled for vaginal birth.
2. Subject is gestating a single fetus.
3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
4. Subject is able and willing to comply with the protocol required follow-up visits.
5. Subject is able and willing to provide written informed consent prior to enrollment.
6. 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.
7. Subject receives epidural anesthesia during labor prior to enrollment.
8. Subject is 18 years of age or older at time of consent.

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 is planning or requires a Caesarean-section prior to randomization.
3. Subject begins labor with less than 36 weeks gestation.
4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
6. Subject has a localized (genital tract) or systemic infection.
7. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
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. Subject has known significant chromosomal or structural fetal anomalies.
11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No