Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage (NOVIC)
Postpartum Hemorrhage, Maternal Death
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Delivery at 34 weeks or greater
- Cumulative blood loss >1000ml within 24 hours after delivery
- Uterine atony
- Receipt of first-line uterotonics
- Cervix at least 3cm dilated at cesarean section
Exclusion Criteria:
- Patient unwilling or unable to provide informed consent
- Retained placenta or other known cause of postpartum hemorrhage
- Placenta accreta spectrum
- Coagulopathy
- Rupture uterus
- Surgical management immediately needed for life-threatening bleeding
- Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection
Sites / Locations
- Komfo Anokye Teaching Hospital
- Korle-bu Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Jada® System
Standard care
Patients in this group will have the Jada® System applied when the initial medical treatment fails, and estimated blood loss reaches 1000 mL. It is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted.
Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy