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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02883673
Other study ID # CIP-01 v2.6
Secondary ID PPH-02
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2017
Est. completion date March 25, 2020

Study information

Verified date August 2022
Source Alydia Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date March 25, 2020
Est. primary completion date January 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States University of Alabama Birmingham Birmingham Alabama
United States University of Virginia Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States MetroHealth Case Western Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Geisinger Medical Center Danville Pennsylvania
United States New York Presbyterian Queens Flushing New York
United States University of Texas Medical Branch Galveston Texas
United States UT Health Science Center, McGovern School of Medicine Houston Texas
United States Indiana University Indianapolis Indiana
United States Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey
United States Nyph/Cumc New York New York
United States UPMC - Magee Women's Hospital Pittsburgh Pennsylvania
United States University of Utah Salt Lake City Utah
United States MedStar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Alydia Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View Citation

Khan KS, Wojdyla D, Say L, Gülmezoglu 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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 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. 6 weeks
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