Postpartum Hemorrhage
Conditions
Keywords
Vacuum-Induced Hemorrhage-Control (VHC), Jada, Postpartum Hemorrhage
Brief summary
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
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.
Interventions
DEVICEJada® System
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.
Sponsors
Alydia Health
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
• Use of the Jada System (inserted into the patient and connected to vacuum). NOTE: There is no
Exclusion criteria
in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Cessation of PPH | 24 hours | 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. |
| Safety: device-related Adverse Events | 24 hours through time of discharge. | Rates of procedure- and device-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-dwelling time of Jada during treatment | 24 hours | In-dwelling time (i.e., insertion of Jada to removal of Jada) |
| Rate of non-surgical or surgical procedures other than Jada | 24 hours | Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used |
| Length of stay | 24 hours through time of discharge. | Length of stay (LOS) from delivery to discharge |
| Time spent in care settings | 24 hours through time of discharge. | Time spent in care settings (e.g., L&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge |
| Transfusion rates | 24 hours through time of discharge. | Rate of blood transfusions |
Countries
United States
Outcome results
None listed