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

Not Applicable

Recruiting

• Conditions: Shoulder Dystocia
• Interventions: Device: Yaari Extractor

• Registration Number: NCT05913609
• Lead Sponsor: FetalEase Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-22
• Study Start: 2023-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-11
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yaari Extractor group	Yaari Extractor	Prospective experimental arm

Primary Outcome Measures

Name	Time	Method
Number of successful neonate deliveries with the Yaari Extractor device	immediately after the intervention	First Primary Effectiveness Endpoint
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery	immediately after the intervention	Second Primary Effectiveness Endpoint
Maternal and neonatal adverse events	through study completion, an average of 5 days	Primary Safety Endpoint

Secondary Outcome Measures

Name	Time	Method
Ease of Use 5 point Likert scale User Questionnaire	immediately after the intervention	Secondary Effectiveness Endpoint

Trial Locations

Locations (3)

University of Miami - Jackson Memorial; 🇺🇸 Miami, Florida, United States

Unified Women's Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States