A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth (NCT06698185) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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