This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery.
The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.
Signed informed consent
Maternal age ≥18 years
Gestational age ≥30+0 weeks of pregnancy at day of delivery
Vital pregnancy
Insufficient language skills in German or English to understand and sign informed consent
Participation in another interventional study
Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)
Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization
Parallel
Rüsch® Balloon Catheter Ch. 24
DeviceAfter cesarean delivery, patients in the intervention group receive the following intervention: The Rüsch® Balloon Catheter Ch. 24 will be inserted directly into the uterus before uterotomy closure. After insertion of the catheter, the catheter balloon is filled up to 80 ml of 0.9% saline solution and connected to the vacuum device whereby an intrauterine vacuum of -60 to a maximum of -70 kPa is applied once the uterotomy is closed. Once the catheter has been positioned, it is left in place for one hour as a prophylactic measure while a vacuum is applied. The device will be removed by draining the liquid in the balloon, after 1 hour of vacuum-induced tamponade. The final decision for removal of the catheter in this study is made by the senior physician responsible for the woman.
Ultrasonography
Other interventionThe position of the balloon catheter as well as the condition of the uterine cavity are assessed immediately postoperatively using ultrasonography.
Change in hemoglobin
The primary outcome is to evaluate the postpartum change in hemoglobin (g/L) after cesarean delivery, comparing patients in the intervention group (treated with standard of care (SOC) plus U-CaVIT) to patients in the control group (treated with SOC).
Postpartum hemoglobin (g/L)
Change of postpartum hemoglobin (g/L): Difference between prepartum and postpartum levels at hospital discharge
Blood loss
Blood loss (ml): Estimated blood loss within 24 hours and during secondary PPH (if applicable).
Further PPH treatment/intervention.
Need for further PPH treatment/intervention
Surgical revision
Second operation within 24 hours
Other outcomes: usability of U-CaVIT
The usability of U-CaVIT will be assessed by the investigators. From 2 days post-procedure until hospital discharge, a patient survey will be conducted to assess a woman's sensations of safety, anxiety, distress, and insecurity, as well as to evaluate personal peripartum satisfaction and experiences with U-CaVIT treatment (if applicable), including measures of discomfort, pain, and other related factors.
Safety Outcome
Incidence of device-related serious adverse events, critical non-serious adverse events and device deficiencies.
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Christian Haslinger
Lead sponsor
University of Zurich
Sponsor institution
University of Zurich
Collaborator
