Postpartum Hemorrhage
Conditions
Keywords
Postpartum Hemorrhage
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.
Interventions
DEVICEJada 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.
Sponsors
Alydia Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging | 24 hrs | 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 |
| Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jada Arm Treatment Arm | 107 |
| Total | 107 |
Baseline characteristics
| Characteristic | Jada Arm |
|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 5.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Region of Enrollment United States | 107 participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 45 / 106 |
| serious Total, serious adverse events | 18 / 106 |
Outcome results
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
Time frame: 24 hrs
Population: Group of participants for whom Jada was activated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ITT Population | Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging | 100 Participants |
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.
Time frame: 6 weeks
Population: Participants in whom Jada was activated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ITT Population | Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants | 8 Participants |