WithdrawnNot Applicable

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

Stopped: Change in IRB jurisdiction for study, study is suspended

United States0Started 2014-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Safety

Timeframe: 3 months post-delivery follow-up

Trial details

NCT IDNCT06698185

SponsorMaterna Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12

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