RUBY Post-Market Registry on the Jada® System

Alydia Health809 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

809

Conditions

Postpartum Hemorrhage

Interventions

Jada® SystemDEVICE

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: • Use of the Jada System (inserted into the patient and connected to vacuum). NOTE: There is no Exclusion Criteria in this protocol.

Locations (16)

Loma Linda University

Loma Linda, California, United States

ChristianaCare

Newark, Delaware, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Safety: device-related Adverse Events

Rates of procedure- and device-related adverse events.

Time frame: 24 hours through time of discharge.

Secondary Outcomes

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

Time frame: 24 hours

Transfusion rates

Rate of blood transfusions

Time frame: 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)

Time frame: 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

Time frame: 24 hours through time of discharge.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.