Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

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.