U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.

Recruiting N/A Interventional Study
Postpartum Hemorrhage (Primary) Hemorrhage Postpartum Complication Delivery ,Complications,Maternal Pregnancy Complications Cesarean Delivery Balloon
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Christian Haslinger · Other
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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) du…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Maternal age ≥18 years * Gestational age ≥30+0 weeks of pregnancy at day of delivery * Vital pregnancy * Delivery mode: planned cesarean delivery * High-risk patient for PPH specified by the presence of at least one of the following characteristics: P…
Contacts

Christian Prof. Dr. med. Haslinger, MD

+41 43 253 75 75

Christian.haslinger@usz.ch

CONTACT

Janine Dünner, MSc

janine.duenner@usz.ch

CONTACT