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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05913609
Other study ID # CLT-005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date April 2026

Study information

Verified date May 2024
Source FetalEase Ltd.
Contact Ahava Stein
Phone +972522346927
Email ahava@asteinrac.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 2026
Est. primary completion date November 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States Inova Fairfax Medical Campus Falls Church Virginia
United States Unified Women's Clinical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
FetalEase Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of successful neonate deliveries with the Yaari Extractor device First Primary Effectiveness Endpoint immediately after the intervention
Primary Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery Second Primary Effectiveness Endpoint immediately after the intervention
Primary Maternal and neonatal adverse events Primary Safety Endpoint through study completion, an average of 5 days
Secondary Ease of Use 5 point Likert scale User Questionnaire Secondary Effectiveness Endpoint immediately after the intervention
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06283277 - Fetal Clavicular Measurement to Predict Fetal Macrosomia
Not yet recruiting NCT02315820 - Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial N/A
Completed NCT05660551 - Investigation of the Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia N/A
Completed NCT01618565 - Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management Phase 3