Shoulder Dystocia
Conditions
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.
Interventions
DEVICEYaari Extractor
The Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device consists of two curved, rigid plastic-coated metal Arms with Handles which are used for control of the device outside the body, and an elastic Engagement Element which conforms to the maternal and neonatal anatomy, and which is used for direct contact with the entrapped neonate within the birth canal.
Sponsors
FetalEase Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use 5 point Likert scale User Questionnaire | immediately after the intervention | Secondary Effectiveness Endpoint |
Countries
United States
Contacts
Primary ContactAhava Stein
Outcome results
None listed