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

This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. The device will be used during the first stage of labor, following initiation of epidural anesthesia and after the cervix has dilated to between 3-8 cm. Up to 20 subjects will be included in the initial study, with the option to increase the number of subjects to 50 based on early data.

Study Overview

• Status: Withdrawn
• Conditions: Childbirth
• Intervention / Treatment: Device: Materna Prep Device; Device: Sham Control

Detailed Description

Study Inclusion Criteria are:

1. Patients attending for antenatal care at El Camino Hospital with the Altos Oaks Obstetrics Group
2. First ongoing pregnancy beyond 20 weeks
3. Singleton, cephalic presentation
4. No pregnancy complications which are likely to require Caesarean Section
5. Planned vaginal delivery

The primary outcome measure is device safety as defined by freedom of device related adverse events. Secondary efficacy outcome measures are:

1. Pelvic muscle damage as determined by ultrasound imaging
2. Length of the 2nd stage of labour
3. Delivery mode
4. Perineal and anal sphincter trauma
5. Symptoms of incontinence, prolapse and sexual dysfunction 2 years postpartum
6. Pelvic organ support (ICS POP-Q system) and pelvic organ descent on ultrasound

Interested patients will have the study presented to them during their pre-natal visits with the Altos Oaks Obstetrics group. Interested patients will have the study explained to them and will be given the Informed Consent document.After the informed consent procedure, patients will undergo an interview and 4D translabial ultrasound.

The screened patients will have the Materna device administered by a researcher from the Altos Oaks Obstetrics group. The patients will be flagged in their charts regarding their participation in this study. When an enrolled patient arrives at the hospital and is deemed to be in labor, the Altos Oaks physician on call will be notified, and called to administer the use of the device. All other obstetric services are provided by routine staff. The device will be dilated up to a maximum diameter of 8-10cm and is then removed to allow delivery. The Control arm patients will experience normal care during labor. Participants are followed up at 3 months and 1 year after childbirth with an interview, including validated questionnaires on bladder, bowel and sexual function, and repeat ultrasound. Delivery details will be collected by the midwives and through the institutional database.

The study's primary efficacy outcome measure is levator avulsion injury diagnosed on volume ultrasound data obtained at the 1-3 month follow-up appointment. Secondary outcomes include both objective findings related to pelvic floor function and anatomy, as well as symptoms of pelvic floor dysfunction such as pelvic organ prolapse, urinary / fecal incontinence and dyspareunia, as ascertained by interview and questionnaire, at 3 months after childbirth. Assessment of stored ultrasound volume data (obtained on pelvic floor muscle contraction, or, if that is not possible, at rest) is undertaken at a later date by one single operator within the Altos Oaks Obstetrics group.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • El Camino Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primiparas, or previous pregnancy terminated before 24 weeks gestation
2. Single fetus birth
3. Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent.
4. Subject is willing and able to comply with specified follow-up evaluations.
5. Planned to have epidural during birthing process

Exclusion Criteria:

1. Previous delivery, or previous pregnancy beyond 24 weeks gestation
2. Less than 36 weeks gestation
3. Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders
4. Muscular or skin disorder that affects elasticity of tissue such as scleroderma or lupus.
5. Local or systemic infection e.g. HIV, herpes
6. Any prior surgical procedures to the vaginal anatomy that could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. Evaluated during baseline screening
7. High likelihood of less than 1 hour of potential device dilation time after the woman arrives at the center and receives epidural

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control	Device: Sham Control; Sham Control
Experimental: Materna Prep Device	Device: Materna Prep Device; Materna Prep Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Freedom from device related adverse events	3 months post-delivery follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Muscle Avulsion	Binary, determined with ultrasound imaging	1-3 months post delivery
Pelvic Muscle Damage	Measured by changes in levator hiatus area, determined with ultrasound imaging	1-3 Months Post-Delivery
Delivery Time	Measure the length of the second phase of labor	Immediate after delivery
Perineal Lacerations	Record the grade of perineal lacerations, and if sutures were used to repair lacerations	Immediate Post Delivery
Instrument Deliveries	Record if instruments were used for delivery	Immediate Post-Delivery

Collaborators and Investigators

• Sponsor: Materna Medical
• Collaborators: El Camino Hospital, Mountain View, CA; Altos Oaks Medical Group, Mountain View, CA
• Investigators: Principal Investigator: Kenneth Weber, MD, Obstatrician, Altos Oaks Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Childbirth, Tearing, perineal lacerations, pelvic muscle, avulsion, pelvic floor disorders, vaginal delivery, instrument delivery, delivery time, ultrasound
• Other Study ID Numbers: MAT-2002