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

NCT06698185 | Withdrawn

• 1 other identifier: MAT-2002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childbirth

Keywords

Childbirth, Tearing, perineal lacerations, pelvic muscle, avulsion, pelvic floor disorders, vaginal delivery, instrument delivery, delivery time, ultrasound

Outcome Measures

Primary Outcomes (1)

• Safety

  Freedom from device related adverse events

  3 months post-delivery follow-up

Secondary Outcomes (5)

• Pelvic Muscle Avulsion

  1-3 months post delivery

• Pelvic Muscle Damage

  1-3 Months Post-Delivery

• Delivery Time

  Immediate after delivery

• Perineal Lacerations

  Immediate Post Delivery

• Instrument Deliveries

  Immediate Post-Delivery

Study Arms (2)

Materna Prep Device

EXPERIMENTAL

Materna Prep Device

Device: Materna Prep Device

Sham Control

SHAM COMPARATOR

Sham Control

Device: Sham Control

Interventions

Materna Prep Device DEVICE

Materna Prep Device

Materna Prep Device

Sham Control DEVICE

Sham Control

Sham Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Previous delivery, or previous pregnancy beyond 24 weeks gestation
• Less than 36 weeks gestation
• Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders
• Muscular or skin disorder that affects elasticity of tissue such as scleroderma or lupus.
• Local or systemic infection e.g. HIV, herpes
• 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
• High likelihood of less than 1 hour of potential device dilation time after the woman arrives at the center and receives epidural

Sponsors & Collaborators

• Materna Medical: lead
• El Camino Hospital, Mountain View, CA: collaborator
• Altos Oaks Medical Group, Mountain View, CA: collaborator

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Lacerations; Fractures, Avulsion; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fractures, Bone; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Kenneth Weber, MD

  Obstatrician, Altos Oaks Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: November 20, 2024
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (1)