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

FetalEase

Status: Enrolling

Conditions: Shoulder Dystocia

Treatments: Device: Yaari Extractor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05913609

CLT-005

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Yaari Extractor group

Experimental group

Description:

Prospective experimental arm

Treatment:

Device: Yaari Extractor

Control group

No Intervention group

Description:

Historical control arm - retrospective review of medical records at the same study sites