Clinical trial NCT05913609: Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Official title: IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Dystocia
Lead sponsor: FetalEase Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of successful neonate deliveries with the Yaari Extractor device
timeFrame: immediately after the intervention
measure: Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
timeFrame: immediately after the intervention
measure: Maternal and neonatal adverse events
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Ease of Use 5 point Likert scale User Questionnaire
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami - Jackson Memorial
state: Florida
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
References: