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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Shoulder Dystocia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yaari Extractor group

Prospective experimental arm

Group Type EXPERIMENTAL

Yaari Extractor

Intervention Type DEVICE

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yaari 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes