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

Completed · Not applicable

Conditions studied: Tear, Pelvic Organ, Obstetric Trauma

In brief

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

Key facts

Study ID

NCT02332759

Run by

Baylor College of Medicine

People needed

61

Starts

2014-07-01

Expected to finish

2016-12-01

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Texas Children's Hospital Pavilion For Women — Houston, Texas, United States

Full record on ClinicalTrials.gov

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