Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
NCT ID: NCT02883673
Last Updated: 2022-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2017-09-17
2020-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Able to understand and provide informed consent to participate in the study.
3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
4. EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.
Exclusion Criteria
2. Delivery at a gestational age \< 34 weeks.
3. For C-sections: Cervix \< 3 cm dilated before Jada use.
4. PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
5. Known uterine anomaly.
6. Ongoing intrauterine pregnancy.
7. Placenta abnormality including any of the following: a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.
10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
11. Current cervical cancer.
12. Current purulent infection of the vagina, cervix, uterus.
13. Diagnosis of coagulopathy.
18 Years
FEMALE
No
Sponsors
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Alydia Health
INDUSTRY
Responsible Party
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Principal Investigators
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Mary D'Alton, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Presbyterian Queens
Flushing, New York, United States
Nyph/Cumc
New York, New York, United States
MetroHealth Case Western
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
UPMC - Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
UT Health Science Center, McGovern School of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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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.
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.
McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PPH-02
Identifier Type: OTHER
Identifier Source: secondary_id
CIP-01 v2.6
Identifier Type: -
Identifier Source: org_study_id
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