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Tests treatment safety and results for Shoulder Dystocia
Official title Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
ClinicalTrials.gov ID: NCT05913609
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic...
- Cesarean section is planned for the patient.
- Obstetric contraindications to vaginal birth.
- Subject carrying fetus with known significant chromosomal or structural anomalies.
- Clinically estimated fetal weight ≥5kg in non-diabetic people.
- Clinically estimated fetal weight ≥4.5kg in people with diabetes.
See the full eligibility 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...
- 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...
- Cesarean section is planned for the patient.
- Obstetric contraindications to vaginal birth.
- Subject carrying fetus with known significant chromosomal or structural anomalies.
- Clinically estimated fetal weight ≥5kg in non-diabetic people.
- Clinically estimated fetal weight ≥4.5kg in people 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.
- Any maternal disease or disorder that precludes the subject from pushing effectively.
- If the maternal cervix is not fully dilated.
- If the fetal head is not completely out of the birth canal.
- In the presence of a non-reducible nuchal cord.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Idaho Falls, Idaho, United States
- Winston-Salem, North Carolina, United States
- Falls Church, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Idaho Falls, Idaho, United States; Winston-Salem, North Carolina, United States; Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.