Postpartum Hemorrhage Clinical Trial
— NOVICOfficial title:
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial
This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.
Status | Recruiting |
Enrollment | 424 |
Est. completion date | April 30, 2027 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - 18 years or older - Delivery at 34 weeks or greater - Cumulative blood loss >1000ml within 24 hours after delivery - Uterine atony - Receipt of first-line uterotonics - Cervix at least 3cm dilated at cesarean section Exclusion Criteria: - Patient unwilling or unable to provide informed consent - Retained placenta or other known cause of postpartum hemorrhage - Placenta accreta spectrum - Coagulopathy - Rupture uterus - Surgical management immediately needed for life-threatening bleeding - Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection |
Country | Name | City | State |
---|---|---|---|
Ghana | Korle-bu Teaching Hospital | Accra | Greater Accra Region |
Ghana | Komfo Anokye Teaching Hospital | Kumasi | Ashanti Region |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island | Kwame Nkrumah University of Science and Technology, University of Ghana, Washington University School of Medicine |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal survival without surgical intervention | No maternal death postpartum up to 6 weeks and no use of surgical interventions | Delivery to 6 weeks post-delivery | |
Secondary | Time from randomization to control of bleeding | Time from use of first line treatment to control of bleeding | 6 weeks postpartum | |
Secondary | Concentration of postpartum hemoglobin | hemoglobin level postpartum | Postpartum day 1 | |
Secondary | Change in hemoglobin concentration from labor admission to postpartum day 1 | Hemoglobin change between labor admission and postpartum | Postpartum day 1 | |
Secondary | Rate of maternal transfusion of blood or blood products postpartum | Transfusion of blood or blood products postpartum | 6 weeks postpartum | |
Secondary | Number of units of blood products transfused | Number of units of blood products transfused | 6 weeks postpartum | |
Secondary | Volume of blood loss post-randomization | An estimate of blood loss from the time of randomization | 6 weeks postpartum | |
Secondary | Surgical procedures performed | Surgical procedures performed, including uterine vascular ligation, uterine compression sutures or hysterectomy | 6 weeks postpartum | |
Secondary | Rate of maternal death postpartum | Maternal death postpartum up to 6 weeks | 6 weeks postpartum | |
Secondary | Number of additional uterotonic used after randomization | Type and number of uterotonic used after the first line oxytocin | 6 weeks postpartum | |
Secondary | Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied) | Patient satisfaction assessed by a score on a scale of 0 (least satisfied) to 10 (most satisfied) | 6 weeks postpartum | |
Secondary | Composite adverse events potentially related to the Jada system | Composite adverse events potentially related to the Jada system, including genital tract injury, uterine perforation or rupture and endometriosis | 6 weeks postpartum | |
Secondary | Quality-adjusted Life-year | Quality-adjusted Life-year based on the literature and Quality of Life Questionnaire (EQ-5D-5L) | 6 weeks postpartum | |
Secondary | Incremental cost per quality-adjusted life-year | Incremental cost per quality-adjusted life-year | 6 weeks postpartum |
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