About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent
Maternal age ≥18 years
Gestational age ≥30+0 weeks of pregnancy at day of delivery
Vital pregnancy
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rüsch® Balloon Catheter Ch. 24
- Ultrasonography
Treatment groups
Sponsors and collaborators
Christian Haslinger
Lead sponsor
University of Zurich
Sponsor institution
University of Zurich
Collaborator