Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia (NCT05913609) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
United States80 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject 18 years of age or older at time of consent.
. Subject planning on vaginal birth.
. Singleton pregnancy in vertex presentation.
. Full-term pregnancy having completed 37 weeks or more gestational weeks.
. Able and willing to provide written informed consent prior to enrollment.
. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
. 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
. 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.)
. Cesarean section is planned for the patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of successful neonate deliveries with the Yaari Extractor device
Timeframe: immediately after the intervention
2
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
Timeframe: immediately after the intervention
3
Maternal and neonatal adverse events
Timeframe: through study completion, an average of 5 days
. Subject carrying fetus with known significant chromosomal or structural anomalies.
. Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
. 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.
. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.