RUBY Post-Market Registry on the Jada® System

Study Overview
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Brief Summary
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The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.

Detailed Description
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The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.

Official Title
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RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Device: Jada® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Use of the Jada System (inserted into the patient and connected to vacuum). NOTE: There is no Exclusion Criteria in this protocol.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C-Section Delivery with EBL ≥ 1500 mL<br>Patients with ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). | Device: Jada® System<br>* The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.<br>* Other names: Obstetric-Gynecologic Specialized Manual Instrument;|
| C-Section Delivery with EBL < 1500 mL<br>Patients with < 1500 mL EBL at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). | Device: Jada® System<br>* The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.<br>* Other names: Obstetric-Gynecologic Specialized Manual Instrument;|
| Vaginal Delivery with EBL ≥ 1000 mL<br>Patients with ≥ 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). | Device: Jada® System<br>* The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.<br>* Other names: Obstetric-Gynecologic Specialized Manual Instrument;|
| Vaginal Delivery with EBL < 1000 mL<br>Patients with < 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). | Device: Jada® System<br>* The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.<br>* Other names: Obstetric-Gynecologic Specialized Manual Instrument;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Cessation of PPH | Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used. Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition. | 24 hours | 
| Safety: device-related Adverse Events | Rates of procedure- and device-related adverse events. | 24 hours through time of discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-surgical or surgical procedures other than Jada | Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used | 24 hours | 
| Transfusion rates | Rate of blood transfusions | 24 hours through time of discharge. | 
| In-dwelling time of Jada during treatment | In-dwelling time (i.e., insertion of Jada to removal of Jada) | 24 hours | 
| Time spent in care settings | Time spent in care settings (e.g., L&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge | 24 hours through time of discharge. | 
| Length of stay | Length of stay (LOS) from delivery to discharge | 24 hours through time of discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage, Vacuum-Induced Hemorrhage-Control (VHC), Jada