EASE: The Materna Prep Pivotal Study

Pelvic Organ Prolapse Clinical Trial

Official title:

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03973281
• Other study ID #: MaternaMedical
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Materna Medical
• Contact: Josh Freeman
• Phone: 866-433-6933
• Email: clinical[@]maternamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 12 months from the time of the use of the device during delivery.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Criteria for inclusion

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:

Criteria for exclusion

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.

12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Delivery

Intervention

Device:
• Materna Prep Device
Materna Prep Device

Other:
• Standard of Care (SOC)
Standard of Care (SOC)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	The Cooper Health System	Camden	New Jersey
United States	The Metro Health System	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	University of California Los Angeles	Los Angeles	California
United States	El Camino Hospital	Mountain View	California
United States	Rutgers Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Columbia University Irving Medical Center	New York	New York
United States	Christiana Care - Center for Women's & Children's Health	Newark	Delaware
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Lewis Katz School of Medicine at Temple	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Materna Medical	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging	Use transperineal ultrasound to identify levator ani muscle detachment	3-month Follow-up
Primary	The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging	Use transperineal ultrasound to identify levator ani muscle detachment	12-month Follow-up
Secondary	The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging	Use transperineal ultrasound to identify levator ani muscle detachments	3-Month Follow-up
Secondary	The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging	Use transperineal ultrasound to identify levator ani muscle detachments	12-Month Follow-up
Secondary	Length of 2nd Stage Labor	Compare the length of the second stage of labor, defined as the time from the cervix being dilated to 10 cm to the complete delivery of the baby between study groups.	Intra-Procedure
Secondary	Levator Hiatal Area	Compare the levator hiatal area (cm2 - measurement between pelvic muscle and pelvic bone)	3-month and 12-month Follow-up
Secondary	Perineal Lacerations	Compare the rate of perineal lacerations determined by visual insepction post-delivery between study groups	Intra-Procedure
Secondary	Obstetric anal sphincter injury - OASI	Compare the rate of tearing of the muscles of the anal sphincter between study groups.	Intra-Procedure
Secondary	Obstetric anal sphincter injury - OASI	Compare the rate of tearing of the muscles of the anal sphincter on ultrasound between study groups.	3-month follow-up
Secondary	C-Sections	Compare the rate of C-Section due to arrest of labot in the second stage	Intra-Procedure
Secondary	Infant APGAR scores	Compare infant APGAR scores between study groups. A score of 7-10 after 5 minutes is reassuring, a score of 4-6 after minutes is moderately abnormal and a score of 0-3 is concerning.	Intra-Procedure
Secondary	Qualitative pelvic health feedback	Compare qualitative pelvic health feedback assessed by PFIQ-7 (utilizing 4-point scale representing "Not at all" to "quite a bit") questionnaires from subjects between study groups.	3-Month and 12-month Follow-up
Secondary	Qualitative pelvic health feedback	Compare qualitative pelvic health feedback assessed by PFID-20 (Utilizing a 5 point scale with 0=not present to 4=quite a bit) questionnaires from subjects between study groups.	3-Month and 12-month Follow-up
Secondary	Qualitative pain	Compare qualitative pain assessed by VAS (0-10, with 0 being No pain and 10 being severe pain) from subjects between study groups	3-Month and12-month Follow-up
Secondary	User Satifaction	Satisfaction assessed by a clinician satisfaction questionnaire after device use.	Intra-Procedure
Secondary	Operative Delivery	Compare the rate of instrument use in vaginal deliveries between study gorups	Intra-Procedure
Secondary	Types of Perineal Lacerations	Compare rate of the TYPES of perineal lacerations between study groups.	Intra-Procedure
Secondary	Reasons for C-Sections	Compare incidence of the REASONS for C-Sections between study groups	Intra-Procedure
Secondary	First Push to Delivery	Compare the mean time form first push to delivery between study groups.	Intra-Procedure