Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
ConditionShoulder Dystocia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFetalEase Ltd.
About 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 accepts healthy volunteersQualifiers
Subject 18 years of age or older at time of consent.
Subject planning on vaginal birth.
Singleton pregnancy in vertex presentation.
Full-term pregnancy having completed 37 weeks or more gestational weeks.
Disqualifiers
Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic pressure with downward traction on the fetal head), prior to use of the Yaari Extractor. (NOTE: Hyperflexion of the hips or legs is allowed prior to and during use of the Yaari Extractor.)
Cesarean section is planned for the patient.
Obstetric contraindications to vaginal birth.
Subject carrying fetus with known significant chromosomal or structural anomalies.
Trial design
Design model
Parallel
Treatments tested in this trial
Yaari Extractor
DeviceThe Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device consists of two curved, rigid plastic-coated metal Arms with Handles which are used for control of the device outside the body, and an elastic Engagement Element which conforms to the maternal and neonatal anatomy, and which is used for direct contact with the entrapped neonate within the birth canal.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Yaari Extractor groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of successful neonate deliveries with the Yaari Extractor device
First Primary Effectiveness Endpoint
Time frame
immediately after the intervention2
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
Second Primary Effectiveness Endpoint
Time frame
immediately after the intervention3
Maternal and neonatal adverse events
Primary Safety Endpoint
Time frame
through study completion, an average of 5 daysSecondary outcomes
1
Ease of Use 5 point Likert scale User Questionnaire
Secondary Effectiveness Endpoint
Time frame
immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov