Yaari Extractor for Shoulder Dystocia
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using anticoagulation medication for a bleeding disorder, you may not be eligible to participate.
What data supports the effectiveness of the treatment Yaari Extractor for shoulder dystocia?
The Yaari Extractor is designed to help guide the baby's shoulder during delivery, which can be crucial in cases of shoulder dystocia (when the baby's shoulder gets stuck during birth). While specific effectiveness data for the Yaari Extractor is not provided, similar instruments have been developed to assist in such situations, suggesting potential value in managing this complication.12345
What makes the Yaari Extractor treatment unique for shoulder dystocia?
The Yaari Extractor, also known as the FetalEase Device, is unique because it is a mechanical device designed to assist in the delivery process by providing a safe and controlled way to manage shoulder dystocia, a condition where the baby's shoulder gets stuck during birth. Unlike traditional methods that rely on manual maneuvers, this device offers a novel approach by potentially reducing the risk of injury to both the mother and baby.678910
What is the purpose of this trial?
Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.
Eligibility Criteria
This trial is for adults over 18 who are at least 37 weeks pregnant, expecting a single baby in head-down position, and planning a vaginal birth. It's specifically for those experiencing shoulder dystocia during delivery—a condition where the baby's shoulder gets stuck after the head is born. Participants must understand and agree to the study.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Yaari Extractor intervention for management of shoulder dystocia
Follow-up
Participants are monitored for maternal and neonatal adverse events
Treatment Details
Interventions
- Yaari Extractor
Yaari Extractor is already approved in United States for the following indications:
- Management of Shoulder Dystocia
Find a Clinic Near You
Who Is Running the Clinical Trial?
FetalEase Ltd.
Lead Sponsor