Principal Investigator: Marcela Smid
Keywords: Postpartum Hemorrhage Department: Obstetrics And Gynecology (Dept)
IRB Number: 00105890
Specialty: Maternal-Fetal Medicine
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Emily Callaway
emily.callaway@hsc.utah.edu
801-587-0975

Brief Summary

 
Purpose of the Study 
 
The purpose of this Pivotal Study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary PPH. 
 
Study Endpoints 
 
Primary Effectiveness Endpoint
 
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. 
 
Non-surgical, second line procedures include uterine balloon therapy, uterine packing, or uterine artery embolization.  Surgical intervention includes procedures such as uterine arterial ligation, uterine compression sutures or hysterectomy. 
 
Note:  Continuation of the administration of uterotonics concomitant with and post Jada use is standard of care as long as such use does not exceed the maximum dose of the drug and does not constitute failure of the primary effectiveness endpoint. 
 
Primary Safety Endpoint.
 
Safety: Incidence, severity and seriousness of device-related Adverse Events.
 
Secondary Endpoints  
  1. Time to control hemorrhage, defined as the time from turning on the vacuum source until the time the first of any of the following occurs:
    1. there is no blood being collected in the tubing or canister, or
    2. the blood loss is observed as leveled off in he canister, or
    3. blood loss is at a rate of <500 ml in 24 hours
  2. Rate of surgical intervention required to control PPH after Jada use.
  3. Rate of non-surgical intervention required to control PPH after Jada use.
  4. Assessment of device usability as reported by the clinician using a dedicated data collection form.
  5. Rate of blood product transfusion required after Jada use, and number of transfusion units when administered.
 

Inclusion Criteria

All patients must be carefully screened against all inclusion and exclusion criteria prior to enrollment in the study,  Each Jada Device will be shipped with a source worksheet listing all eligibiliy criteria, which should be used to ensure compliance with study eligibility criteria during subject enrollment. 

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, determined when investigator is ready to have the Jada peel pack opened:
    1. Vaginal delivery:  500 - 1500 ml EBL
    2. Ce-section delivery: 1000 - 1500 ml EBL
  5. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Note:  Uterotonic administration may continue concomitant with and post Jada use, as long as such use does not exceed the maximum dose of the drug.. 

Exclusion Criteria

Exclusion Criteria: 

  1. EBL >1500ml, 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 use of Jada.
  4. PPH that the investigator determines to require more aggressive treatment, including any of the following:
    1. hysterectomy;
    2. b-lynch suture;
    3. uterine artery embolization or ligation;
    4. hypogastric ligation.
  5. Known uterine anomaly.
  6. Ongoing intrauterine pregnancy.
  7. Placenta abnormality including any of the following:
    1. known placenta accreta;
    2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
    3. 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 Jada.
  11. Current cervical cancer.
  12. Current purulent infection of vagina, cervix, uterus.
  13. Diagnosis of coagulopathy.