Using the Yaari Extractor to manage shoulder dystocia during vaginal births

IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

This study is testing a new device called the Yaari Extractor to see if it can help safely manage shoulder dystocia during vaginal births for women who are at least 18 years old and having a full-term pregnancy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: FetalEase Ltd. (Industry-sponsored)
• Locations: 4 sites (Miami, Florida and 3 other locations)
• Trial ID: NCT05913609 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Yaari Extractor, a device designed to assist in the management of shoulder dystocia during vaginal deliveries. Conducted across multiple centers, the trial involves board certified or board eligible OB/GYN physicians who will use the extractor on patients experiencing shoulder dystocia. The study will compare outcomes with historical controls to assess the device's performance in real-world settings. Participants must be at least 18 years old, planning a vaginal birth, and have a singleton pregnancy at full term.

Who should consider this trial

Good fit: Ideal candidates are pregnant individuals aged 18 or older, planning a vaginal birth with a singleton fetus in vertex presentation who are experiencing shoulder dystocia.

Not a fit: Patients who have already undergone standard maneuvers for shoulder dystocia or those planning a cesarean section will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective method for managing shoulder dystocia during childbirth.

How similar studies have performed: While there may be existing studies on shoulder dystocia management, the use of the Yaari Extractor represents a novel approach that has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Subject 18 years of age or older at time of consent.
2. Subject planning on vaginal birth.
3. Singleton pregnancy in vertex presentation.
4. Full-term pregnancy having completed 37 weeks or more gestational weeks.
5. Able and willing to provide written informed consent prior to enrollment.
6. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
7. Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery."

Exclusion Criteria:

1. 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.)
2. Cesarean section is planned for the patient.
3. Obstetric contraindications to vaginal birth.
4. Subject carrying fetus with known significant chromosomal or structural anomalies.
5. Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
6. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
7. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
8. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.
9. Any maternal disease or disorder that precludes the subject from pushing effectively.
10. If the maternal cervix is not fully dilated.
11. If the fetal head is not completely out of the birth canal.
12. In the presence of a non-reducible nuchal cord.

Where this trial is running

Miami, Florida and 3 other locations

• University of Miami - Jackson Memorial — Miami, Florida, United States (Recruiting)
• Rosemark WomenCare Specialist — Idaho Falls, Idaho, United States (Recruiting)
• Unified Women's Clinical Research — Winston-Salem, North Carolina, United States (Recruiting)
• Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Ahava Stein

Conditions Shoulder Dystocia