NCT02883673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

September 17, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 12, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2.4 years

First QC Date

August 25, 2016

Results QC Date

April 29, 2021

Last Update Submit

August 18, 2022

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.

Device: Jada System

Interventions

Jada SystemDEVICE

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Female, 18 years of age or older at time of consent.
  • Able to understand and provide informed consent to participate in the study.
  • Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
  • 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.
  • 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.

You may not qualify if:

  • EBL \> 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
  • Delivery at a gestational age \< 34 weeks.
  • For C-sections: Cervix \< 3 cm dilated before Jada use.
  • 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.
  • Known uterine anomaly.
  • Ongoing intrauterine pregnancy.
  • 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.
  • Known uterine rupture.
  • Unresolved uterine inversion.
  • Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
  • Current cervical cancer.
  • Current purulent infection of the vagina, cervix, uterus.
  • Diagnosis of coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

New York Presbyterian Queens

Flushing, New York, 11355, United States

Location

Nyph/Cumc

New York, New York, 10032, United States

Location

MetroHealth Case Western

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

UPMC - Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

UT Health Science Center, McGovern School of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (9)

  • 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.

    PMID: 18819848BACKGROUND

  • 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.

    PMID: 16581405BACKGROUND

  • McLintock C, James AH. Obstetric hemorrhage. J Thromb Haemost. 2011 Aug;9(8):1441-51. doi: 10.1111/j.1538-7836.2011.04398.x.

    PMID: 21668737BACKGROUND

  • 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.

    PMID: 17012482BACKGROUND

  • 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.

    PMID: 20129226BACKGROUND

  • 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.

    PMID: 9703148BACKGROUND

  • 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.

    PMID: 18715412BACKGROUND

  • 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.

    PMID: 37713322DERIVED

  • 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.

    PMID: 32909970DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kathryn Wine, VP Clinical Operations
Organization
Alydia Health
kathryn@alydiahealth.com
415-990-4104

Study Officials

  • Mary D'Alton, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

September 17, 2017

Primary Completion

January 26, 2020

Study Completion

March 25, 2020

Last Updated

August 22, 2022

Results First Posted

April 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(15)