Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
Eligibility Criteria
Inclusion Criteria: * Adult Female, 18 years of age or older at time of consent. * Subject is able to understand and provide informed consent to participate in the study. * Diagnosis of abnormal postpartum uterine bleeding (500 - 999 ml for vaginal birth) or postpartum hemorrhage (1000 - 1500 ml for vaginal or Cesarean birth) with suspected atony within 24 hours after vaginal or cesarean birth. * EBL, to be determined when investigator is ready to have the KOKO packaging opened: Vaginal birth: 500 - 1500 ml EBL or Cesarean birth: 1000 - 1500 ml EBL. * Failed first - line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitant with and post KOKO use. Exclusion Criteria: * EBL \>1500ml, to be determined when investigator is ready to have the KOKO packaging opened. * Delivery at a gestational age \< 34 weeks or, if multiples, uterus is judged \<34 weeks size. * For cesarean births: Cervix \< 2.5 cm