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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol No. PPH-05 | Other Identifier | Alydia Health |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-Section Delivery with EBL ≥ 1500 mL | 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). |
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| C-Section Delivery with EBL < 1500 mL | 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). |
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| Vaginal Delivery with EBL ≥ 1000 mL | 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). |
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| Vaginal Delivery with EBL < 1000 mL | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jada® System | Device | 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. |
| 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. |
| 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 |
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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.
Conditions treated occur only in females of childbearing age (i.e., postpartum hemorrhage or abnormal postpartum uterine bleeding).
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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):
Up to a maximum of 50 sites can be included in this registry. Each IRB approval constitutes a "site."
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| Name | Affiliation | Role |
|---|---|---|
| Dena Goffman, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States | ||
| ChristianaCare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27227224 | Background | Gulmezoglu AM, Lawrie TA, Hezelgrave N, Oladapo OT, Souza JP, Gielen M, Lawn JE, Bahl R, Althabe F, Colaci D, Hofmeyr GJ. Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In: Black RE, Laxminarayan R, Temmerman M, Walker N, editors. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Apr 5. Chapter 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK361904/ | |
| 20350642 |
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It is not yet known if there will be a plan to make IPD available.
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|
|
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. |
| Newark |
| Delaware |
| 19718 |
| United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Oshsner Baptist | New Orleans | Louisiana | 70115 | United States |
| Allina (Abbott Northwestern) | Minneapolis | Minnesota | 55409 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Nyph/Cumc | New York | New York | 10032 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Ohio Health | Gahanna | Ohio | 43230 | United States |
| UPMC - Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Charleston Birth Place | Mt. Pleasant | South Carolina | 29464 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25302 | United States |
| Background |
| 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. |
| 11844171 | Background | Mulic-Lutvica A, Bekuretsion M, Bakos O, Axelsson O. Ultrasonic evaluation of the uterus and uterine cavity after normal, vaginal delivery. Ultrasound Obstet Gynecol. 2001 Nov;18(5):491-8. doi: 10.1046/j.0960-7692.2001.00561.x. |
| Background | Andersen HF, Hopkins MP. Chapter 80: postpartum hemorrhage. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004. |
| Background | Lyon DS. Chapter 90: postpartum care. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004. |
| 11089490 | Background | Baskett TF. A flux of the reds: evolution of active management of the third stage of labour. J R Soc Med. 2000 Sep;93(9):489-93. doi: 10.1177/014107680009300913. No abstract available. |
| 26241269 | Background | Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869. |
| 30609429 | Background | Goffman D, Ananth CV, Fleischer A, D'Alton M, Lavery JA, Smiley R, Zielinski K, Chazotte C; Safe Motherhood Initiative Obstetric Hemorrhage Work Group. The New York State Safe Motherhood Initiative: Early Impact of Obstetric Hemorrhage Bundle Implementation. Am J Perinatol. 2019 Nov;36(13):1344-1350. doi: 10.1055/s-0038-1676976. Epub 2019 Jan 4. |
| 22083059 | Background | Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. Am J Obstet Gynecol. 2011 Oct;205(4):368.e1-8. doi: 10.1016/j.ajog.2011.06.084. Epub 2011 Jun 29. |
| 20809871 | Background | 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. |
| 21698554 | Background | 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. |
| 17012482 | Background | 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. |
| 21173639 | Background | Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available. |
| 27275795 | Background | 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. |
| 32909970 | Background | 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. |
| 39924257 | Derived | Rood KM, Bianco A, Biggio JR, Smid MC, Simhan HN, Li J, Yong C, Carney PI, Croft DJ, Goffman D. Real-world use of a vacuum-induced hemorrhage-control device in births <34 weeks gestational age. J Matern Fetal Neonatal Med. 2025 Dec;38(1):2451658. doi: 10.1080/14767058.2025.2451658. Epub 2025 Feb 9. |
| 37713322 | Derived | Goffman D, Rood KM, Bianco A, Biggio JR, Dietz P, Drake K, Heilman E, Hopkins M, De Four Jones M, Katz T, Martin C, Prasad M, Smid MC, Wine KD, Ryan R, Yong C, Carney PI, Simhan HN. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstet Gynecol. 2023 Nov 1;142(5):1006-1016. doi: 10.1097/AOG.0000000000005366. Epub 2023 Sep 13. |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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