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

NCT02332759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-08-06

No results posted yet for this study

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

Interventions

DEVICE

Materna Medical

Sponsors & Collaborators

  • Materna Medical

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Susan M Ramin, M.D. · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332759 on ClinicalTrials.gov