RUBY Post-Market Registry on the Jada® System
- Conditions
- Postpartum Hemorrhage
- Interventions
- Device: Jada® System
- Registration Number
- NCT04995887
- Lead Sponsor
- Alydia Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 809
• Use of the Jada System (inserted into the patient and connected to vacuum).
NOTE: There is no Exclusion Criteria in this protocol.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description C-Section Delivery with EBL < 1500 mL Jada® System 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). Vaginal Delivery with EBL ≥ 1000 mL Jada® System 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). Vaginal Delivery with EBL < 1000 mL Jada® System 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). C-Section Delivery with EBL ≥ 1500 mL Jada® System 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).
- Primary Outcome Measures
Name Time Method Safety: device-related Adverse Events 24 hours through time of discharge. Rates of procedure- and device-related adverse events.
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.
- Secondary Outcome Measures
Name Time Method Transfusion rates 24 hours through time of discharge. Rate of blood transfusions
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
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
In-dwelling time of Jada during treatment 24 hours In-dwelling time (i.e., insertion of Jada to removal of Jada)
Trial Locations
- Locations (16)
ChristianaCare
🇺🇸Newark, Delaware, United States
Oshsner Baptist
🇺🇸New Orleans, Louisiana, United States
Ohio Health
🇺🇸Gahanna, Ohio, United States
Mount Sinai
🇺🇸New York, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Nyph/Cumc
🇺🇸New York, New York, United States
Charleston Birth Place
🇺🇸Mount Pleasant, South Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
UPMC - Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Allina (Abbott Northwestern)
🇺🇸Minneapolis, Minnesota, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States