Actively Recruiting
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Led by FetalEase Ltd. · Updated on 2025-11-25
80
Participants Needed
4
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at time of consent
- Planning on vaginal birth
- Singleton pregnancy in vertex presentation
- Full-term pregnancy with 37 weeks or more gestation
- Able and willing to provide written informed consent
- Sufficient mental capacity to understand the informed consent form
- Fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178
You will not qualify if you...
- Prior attempted delivery using standard first-line maneuvers before using the Yaari Extractor
- Planned cesarean section
- Obstetric contraindications to vaginal birth
- Fetus with known significant chromosomal or structural anomalies
- Estimated fetal weight ≥5kg in non-diabetic subjects
- Estimated fetal weight ≥4.5kg in subjects with diabetes
- General health conditions or systemic diseases increasing risk with device use or pregnancy
- Bleeding disorders or use of anticoagulation medication
- Maternal diseases or disorders preventing effective pushing
- Maternal cervix not fully dilated
- Fetal head not completely out of the birth canal
- Presence of a non-reducible nuchal cord
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Miami - Jackson Memorial
Miami, Florida, United States, 33136
Actively Recruiting
2
Rosemark WomenCare Specialist
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
3
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
4
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
A
Ahava Stein
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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