N/A
Completed N=107
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Source: ClinicalTrials.gov NCT02883673 ↗Enrolled (actual)
107
Serious AEs
17.0%
Results posted
Apr 2022
Primary outcomePrimary: Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging — 100 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging |
100 | — |
| PRIMARY Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants |
8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02883673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.