MATERNA MEDICAL — Department of Health and Human Services SBIR Phase I: NICHD

Description

Vaginal delivery involves a high risk of pelvic injury damage that can lead to lifelong pelvic floor disorders for mothersand can be a stressful event for babies where long delivery timesinstrumented deliveriesand Csections are the result of difficult deliveriesBoth maternal injuries and longer delivery times are challenged that are posed by the same biomechanical phenomenon of pelvic tissue resistance during childbirthCurrentlythere are no dilation protocols or devices that can shorten delivery and prevent pelvic tissue injuriesThere is an urgent unmet clinical need to ease delivery and prevent injuries that may arise from childbirthThe Materna Device is a mechanical birth dilator that pre stretches pelvic muscles overhour during the first phase of laborthus easing delivery by reducing tissue resistanceIt was used safely as designed during the second active phase of labor insubjectsNo injurieslacerationsvaginal tearingor adverse events occurred due to its usageIn this SBIR Fast Track applicationwe plan toioptimize dilation protocol as to time and duration of placement of the Deviceiireduce delivery time byandiiilower the risk of pelvic tissue injury fromof all births to less thanThis Project is based on a proven collaboration between Materna Medicaldevice functionality and safety featuresBaylor College of Medicineclinical study and dataand the Pelvic Floor Research Group at the University of Michiganmodeling of tissue biomechanicsOur Specific Aims are toDetermine the optimal clinical protocol for the Materna Device using computer simulationsComputer models will be updated to optimize the dilation protocol for the Device using biomechanical data from the prior clinical Phase I studyFinalize Materna Device designbuild and produce Devices for the studyThe Phase II study Device design is essentially completehere we will bench test the designand update its data collection systemSubmit and receive approval of Clinical ProtocolOnce the required Device modifications that provide the optimal dilation protocol have been determinedthe Clinical Protocol will be finalized and submitted for IRB approvalDemonstrate in a randomized controlled trial conducted at a single sitenthat pre dilation by the Materna Device of the vaginal canal and pelvic floor muscles tocm during the first stage of labor could shorten the second stage of labor and lead to fewer pubovisceral muscle tears and avulsionsThis Phase II study is designed to provide the data required to submit the Materna Device for FDA clearanceUtilize computer simulations to develop predictive parameters to identify women at risk for sequelae following vaginal deliveryHerewe will use patient data from Aimto update our biomechanical model so it will better predict birth canal behavior during deliveryIf successfulwe believe the Materna Device may become part of a new standard of care for childbirthwhich could lower instrumented deliveries and emergency C section ratesas well as reduce pelvic muscle injuries and lifelong pelvic floor disorders for immediate improvements in care and reductions in long term sequelae Vaginal delivery involves a high risk of maternal pelvic injury that can lead to lifelong pelvic floor disorders for mothersespecially when delivery times are long and difficultThe Materna Device is a mechanical birth dilator that pre stretches pelvic muscles during the first phase of laboran approach that was shown in a clinical Phase I study to be safeIn this SBIR Fast Track applicationwe propose to conduct a clinical Phase II study to show an improvement in at least one of two maternal physiological outcomesa reduction in delivery timeand ora statistically significant reduction in maternal pelvic injuries