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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yaari Extractor group | Experimental | Prospective experimental arm |
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| Control group | No Intervention | Historical control arm - retrospective review of medical records at the same study sites |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yaari Extractor | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful neonate deliveries with the Yaari Extractor device | First Primary Effectiveness Endpoint | immediately after the intervention |
| Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery | Second Primary Effectiveness Endpoint | immediately after the intervention |
| Maternal and neonatal adverse events | Primary Safety Endpoint | through study completion, an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use 5 point Likert scale User Questionnaire | Secondary Effectiveness Endpoint | immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahava Stein | Contact | +972522346927 | ahava@asteinrac.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami - Jackson Memorial | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000080883 | Shoulder Dystocia |
| ID | Term |
|---|---|
| D004420 | Dystocia |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Rosemark WomenCare Specialist | Recruiting | Idaho Falls | Idaho | 83404 | United States |
|
| Unified Women's Clinical Research | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Inova Fairfax Medical Campus | Recruiting | Falls Church | Virginia | 22042 | United States |
|
| D000091642 | Urogenital Diseases |