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.
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