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| ID | Type | Description | Link |
|---|---|---|---|
| PPH-02 | Other Identifier | Alydia Health |
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The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jada System | Device | 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: Rate of Participants With Cessation of Uterine Hemorrhaging | Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use | 24 hrs |
| Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants | Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary D'Alton, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| MedStar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18819848 | Background | Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25. | |
| 16581405 | Background | Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage. Jada System: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2019 |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| New York Presbyterian Queens | Flushing | New York | 11355 | United States |
| Nyph/Cumc | New York | New York | 10032 | United States |
| MetroHealth Case Western | Cleveland | Ohio | 44109 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| UPMC - Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| UT Health Science Center, McGovern School of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| 21668737 | Background | McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x. |
| 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. |
| 20129226 | Background | Schorn MN. Measurement of blood loss: review of the literature. J Midwifery Womens Health. 2010 Jan-Feb;55(1):20-7. doi: 10.1016/j.jmwh.2009.02.014. |
| 9703148 | Background | Sapadin AN, Lebwohl MG, Teich SA, Phelps RG, DiCostanzo D, Cohen SR. Periumbilical pseudoxanthoma elasticum associated with chronic renal failure and angioid streaks--apparent regression with hemodialysis. J Am Acad Dermatol. 1998 Aug;39(2 Pt 2):338-44. doi: 10.1016/s0190-9622(98)70385-8. |
| 18715412 | Background | Al-Zirqi I, Vangen S, Forsen L, Stray-Pedersen B. Prevalence and risk factors of severe obstetric haemorrhage. BJOG. 2008 Sep;115(10):1265-72. doi: 10.1111/j.1471-0528.2008.01859.x. |
| 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. |
| 32909970 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Jada Arm | Treatment Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging | Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use | Group of participants for whom Jada was activated | Posted | Count of Participants | Participants | 24 hrs |
|
|
| ||||||||||||||||||||||||||
| Primary | Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants | Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study. | Participants in whom Jada was activated | Posted | Count of Participants | Participants | 6 weeks |
|
|
Adverse events were collected from patient admission through 6-week follow-up visit post discharge (follow-up visit window was 42 days +/- 14 days).
Safety/Intent to Treat (ITT) Cohort: All subjects in whom treatment was attempted with Jada (i.e., device inserted, and vacuum turned on) were included in the Safety/ITT Cohort.
One subject was excluded from the Safety/ITT analysis population as the Jada System was unable to be inserted and therefore vacuum treatment was not turned on/connected, leaving 106 subjects for the Safety/ITT Cohort. Notably there were no adverse events reported for this one excluded subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ITT Population | Group where Jada treatment was applied | 0 | 106 | 18 | 106 | 45 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometritis | Infections and infestations | Systematic Assessment | Endometritis |
| |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Anemia |
| |
| Anemia leading to hysterectomy | Blood and lymphatic system disorders | Systematic Assessment | Anemia leading to hysterectomy |
| |
| Anemia and tachycardia and hypotension | Blood and lymphatic system disorders | Systematic Assessment | Anemia and tachycardia and hypotension |
| |
| Continued bleeding due to undiscovered retained placenta | Blood and lymphatic system disorders | Systematic Assessment | Continued bleeding due to undiscovered retained placenta |
| |
| Hypotension with complaint of dyspnea and nausea | Cardiac disorders | Systematic Assessment | Hypotension with complaint of dyspnea and nausea |
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| Pregnancy related hypertension | Cardiac disorders | Systematic Assessment | Pregnancy related hypertension |
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| C-section incision repair bleed | Surgical and medical procedures | Systematic Assessment | C-section incision repair bleed |
| |
| Constipation and hemorrhoid | Gastrointestinal disorders | Systematic Assessment | Constipation and hemorrhoid |
| |
| Laceration of cervix during difficult amniotomy | Skin and subcutaneous tissue disorders | Systematic Assessment | Laceration of cervix during difficult amniotomy |
| |
| Acute tubular necrosis | Renal and urinary disorders | Systematic Assessment | Acute tubular necrosis |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary edema |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Shortness of breath |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Anemia |
| |
| Anemia with tachycardia | Blood and lymphatic system disorders | Systematic Assessment | Anemia with tachycardia |
| |
| Lower uterine segment clot requiring removal | Blood and lymphatic system disorders | Systematic Assessment | Lower uterine segment clot requiring removal |
| |
| Passed clots at 4 weeks postpartum with pain | Blood and lymphatic system disorders | Systematic Assessment | Passed clots at 4 weeks postpartum with pain |
| |
| Pretibial edema | Blood and lymphatic system disorders | Systematic Assessment | Pretibial edema |
| |
| Chest pain, SOB, diplopia, nausea without lab evidence of MI resolved without sequalae | Cardiac disorders | Systematic Assessment | Chest pain, SOB, diplopia, nausea without lab evidence of MI resolved without sequalae |
| |
| Pregnancy related hypertension | Cardiac disorders | Systematic Assessment | Pregnancy related hypertension |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Cellulitis |
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| Cellulitis with yeast | Skin and subcutaneous tissue disorders | Systematic Assessment | Cellulitis with yeast |
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| labial cyst | Skin and subcutaneous tissue disorders | Systematic Assessment | labial cyst |
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| Leg rash associated with medication for hypertension | Skin and subcutaneous tissue disorders | Systematic Assessment | Leg rash associated with medication for hypertension |
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| Constipation | Gastrointestinal disorders | Systematic Assessment | Constipation |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment | Dyspepsia |
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| Hemorrhoid | Gastrointestinal disorders | Systematic Assessment | Hemorrhoid |
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| Presumed endometritis | Infections and infestations | Systematic Assessment | Presumed endometritis |
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| Presumed endometritis with pre-existing chorioamnionitis | Infections and infestations | Systematic Assessment | Presumed endometritis with pre-existing chorioamnionitis |
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| upper respiratory tract influenza | Infections and infestations | Systematic Assessment | upper respiratory tract influenza |
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| Presumed endometritis with leukocytosis | Infections and infestations | Systematic Assessment | Presumed endometritis with leukocytosis |
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| bacterial vaginosis | Infections and infestations | Systematic Assessment | bacterial vaginosis |
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| Chlamydia | Infections and infestations | Systematic Assessment | Chlamydia |
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| Endometritis | Infections and infestations | Systematic Assessment | Endometritis |
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| Mastitis | Infections and infestations | Systematic Assessment | Mastitis |
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| Uncomplicated urinary tract infection | Infections and infestations | Systematic Assessment | Uncomplicated urinary tract infection |
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| Vaginal yeast | Infections and infestations | Systematic Assessment | Vaginal yeast |
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| Migraine headache | Nervous system disorders | Systematic Assessment | Migraine headache |
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| Spinal headache | Nervous system disorders | Systematic Assessment | Spinal headache |
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| Vaginal pain and light bleeding from pre-existing laceration | Skin and subcutaneous tissue disorders | Systematic Assessment | Vaginal pain and light bleeding from pre-existing laceration |
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| Breast rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Breast rash |
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| Breast pain possibly blocked duct | Reproductive system and breast disorders | Systematic Assessment | Breast pain possibly blocked duct |
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| Dysuria | Renal and urinary disorders | Systematic Assessment | Dysuria |
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| Headache | Nervous system disorders | Systematic Assessment | Headache |
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| Pelvic and perineal pain | Reproductive system and breast disorders | Systematic Assessment | Pelvic and perineal pain |
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| Anxiety | Psychiatric disorders | Systematic Assessment | Anxiety |
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| Depression | Psychiatric disorders | Systematic Assessment | Depression |
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| Depression, anxiety, PTSD | Psychiatric disorders | Systematic Assessment | Depression, anxiety, PTSD |
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| acute tubular necrosis | Renal and urinary disorders | Systematic Assessment | acute tubular necrosis |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hypoxia |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary edema |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Shortness of breath |
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| Disruption of laceration repair | Skin and subcutaneous tissue disorders | Systematic Assessment | Disruption of laceration repair |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Wine, VP Clinical Operations | Alydia Health | 415-990-4104 | kathryn@alydiahealth.com |
| Apr 29, 2021 |
| Prot_SAP_000.pdf |
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| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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|