Clinical trial NCT02883673: Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Official title: Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Hemorrhage
Lead sponsor: Alydia Health
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

Eligibility criteria: Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.
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:

1. EBL \> 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
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.

Primary outcomes:
measure: Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging
timeFrame: 24 hrs
measure: Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Flushing
country: United States
facility: New York Presbyterian Queens
state: New York
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Cleveland
country: United States
facility: MetroHealth Case Western
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Magee Women's Hospital
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: UT Health Science Center, McGovern School of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Columbia University
name: Mary D'Alton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.
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.
citation: 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.
citation: 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.
citation: 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.
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.