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Completed
NCT06452355
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Conditions: Postpartum Hemorrhage, Immediate Postpartum Hemorrhage, Hemorrhage, Postpartum
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 73
Sponsor: KOKO Medical Inc.
Location: University of Alabama Birmingham Alabama
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 \
Source: ClinicalTrials.gov (NCT06452355). StuddyBuddy aggregates publicly available trial information.
