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

NCT02332759 | Completed

• 1 other identifier: H- 31936
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of trained clinical labor and delivery providers

Conditions

Tear, Pelvic Organ, Obstetric Trauma

Outcome Measures

Primary Outcomes (1)

• No adverse events related to device

  12-20 week postpartum follow up

Secondary Outcomes (1)

• Reduction in perineal lacerations and pelvic floor trauma

  12-20 week postpartum follow up

Study Arms (1)

Materna Device

EXPERIMENTAL

The device will be inserted vaginally for one hour during active phase of labor to dilate the vaginal canal.

Device: Materna Medical

Interventions

Materna Medical DEVICE

Materna Device

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 effects elasticity of tissue such as scleroderma or lupus
• Local or systemic infection e.g. HIV, herpes
• Diabetes
• Clinically estimated fetal weight \> 4,500 grams
• Any prior surgical procedures to the vaginal anatomy which 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
• A cervical dilation of greater than or equal to 6 cm
• BMI \> 32.5 prior to becoming pregnant

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Materna Medical: collaborator

Study Sites (1)

Texas Children's Hospital Pavilion For Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Susan M Ramin, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: July 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)