Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Launched by FETALEASE LTD. · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Yaari Extractor, which is being tested to see if it is safe and effective for helping doctors manage a situation called shoulder dystocia during childbirth. Shoulder dystocia occurs when the baby's shoulders get stuck after the head has been delivered, making it difficult for the baby to be born. The trial involves several hospitals and is looking for women who are at least 18 years old, are planning to have a vaginal birth, and are at least 37 weeks pregnant with a single baby in the head-down position.

To participate, women must be able to understand and agree to the study, and their baby must be experiencing shoulder dystocia. However, women who have already had certain standard treatments or have planned a cesarean section, among other specific health conditions, will not be eligible. Participants can expect to use the Yaari Extractor during delivery if shoulder dystocia occurs, and their experiences will help researchers learn more about its safety and effectiveness in real-life situations.

Gender

FEMALE

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 ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to 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.