Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

— PEARLE  

Official title:

Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

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
• 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
• 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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

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