Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Prospective, Single-Arm Confirmatory Clinical Investigation to Demonstrate the Effectiveness, Performance, and Safety of the Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).

Inclusion Criteria:

• Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
• Female Adult subjects (>18 years of age).
• Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery.
• Subjects with coagulation disorders can be included
• Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section.
• Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use.
• Subjects with PPH of cervical or vaginal origin.

Exclusion Criteria:

Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE).

• Pregnancy or incomplete multiple pregnancy
• Unresolved uterine inversion.
• Current cervical cancer.
• Current purulent infection of the vagina, cervix, uterus.
• Planned c-section with closed cervix.
• Patients requiring trans-abdominal insertion of Celox™ PPH.