Clinical trial NCT04995887: RUBY Post-Market Registry on the Jada® System
Official title: RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: Vacuum-Induced Hemorrhage-Control (VHC)
Jada
Postpartum Hemorrhage
Lead sponsor: Alydia Health
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 809
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included are all identified through review of the medical charts as having received Jada treatment starting from the center's first commercial use of the Jada System. This chart review will be ongoing until the specified date or until a minimum of 100 patients are enrolled in each of the groups described below (whichever occurs first):

1. ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion (C-S)
2. \< 1500 mL EBL at time of Jada insertion (C-S)
3. ≥ 1000 mL EBL at time of Jada insertion (vaginal)
4. \< 1000 mL EBL at time of Jada insertion (vaginal)

Up to a maximum of 50 sites can be included in this registry. Each IRB approval constitutes a "site."

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.

Eligibility criteria: Inclusion Criteria:

• Use of the Jada System (inserted into the patient and connected to vacuum).

NOTE: There is no Exclusion Criteria in this protocol.

Primary outcomes:
measure: Efficacy: Cessation of PPH
timeFrame: 24 hours
measure: Safety: device-related Adverse Events
timeFrame: 24 hours through time of discharge.
Secondary outcomes:
measure: Rate of non-surgical or surgical procedures other than Jada
timeFrame: 24 hours
measure: Transfusion rates
timeFrame: 24 hours through time of discharge.
measure: In-dwelling time of Jada during treatment
timeFrame: 24 hours
measure: Time spent in care settings
timeFrame: 24 hours through time of discharge.
measure: Length of stay
timeFrame: 24 hours through time of discharge.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Newark
country: United States
facility: ChristianaCare
state: Delaware
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: New Orleans
country: United States
facility: Oshsner Baptist
state: Louisiana
city: Minneapolis
country: United States
facility: Allina (Abbott Northwestern)
state: Minnesota
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Gahanna
country: United States
facility: Ohio Health
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC - Magee Women's Hospital
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Charleston Birth Place
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: Columbia University
name: Dena Goffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011.
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citation: Rossen J, Okland I, Nilsen OB, Eggebo TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324.
citation: Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22.
citation: American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.
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citation: Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.
citation: D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.