NCT05913609招募中不适用
IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Number of successful neonate deliveries with the Yaari Extractor device
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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."
排除标准
- •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.
- •Obstetric contraindications to vaginal birth.
- •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.
- •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.
结局指标
主要结局
Number of successful neonate deliveries with the Yaari Extractor device
时间窗: immediately after the intervention
First Primary Effectiveness Endpoint
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
时间窗: immediately after the intervention
Second Primary Effectiveness Endpoint
Maternal and neonatal adverse events
时间窗: through study completion, an average of 5 days
Primary Safety Endpoint
次要结局
- Ease of Use 5 point Likert scale User Questionnaire(immediately after the intervention)
研究者
研究点 (8)
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