New device aims to stop deadly postpartum bleeding when drugs fail

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery. 4. EBL, determined when investigator is ready to have the Alma peel pack opened: Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL 5. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria 1. EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened. 2. Delivery at a gestational age \< 34 weeks. 3. For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma. 4. PPH that the investigator determines to require more aggressive treatment, including any of the following: 1. hysterectomy; 2. b-lynch suture; 3. uterine artery embolization or ligation; 4. hypogastric ligation. 5. Known uterine anomaly. 6. Ongoing intrauterine pregnancy. 7. Placenta abnormality including any of the following: 1. known placenta accreta; 2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa); 3. retained placenta without easy manual removal. 8. Known uterine rupture. 9. Unresolved uterine inversion. 10. Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma. 11. Current cervical cancer. 12. Current purulent infection of vagina, cervix, uterus. 13. Diagnosis of coagulopathy.