U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Sec… (NCT07019623) | Clinical Trial Compass
RecruitingNot Applicable
U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.
Switzerland70 participantsStarted 2025-05-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: Previous PPH, obesity (BMI ≥30 kg/m2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \> 25 cm or deepest amniotic fluid pocket \> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)
Exclusion Criteria:
* 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
* Women with regular and painful contractions and women who do not have time for sufficient consideration
* Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:
* Uterine or vaginal anomalies (genital tract congenital anomalies)
* Cesarean section due to placenta previa or suspected placenta accreta spectrum
* Suspected uterine rupture
* Injuries of the cervix or vagina
* Submuco…
What they're measuring
1
Change in hemoglobin
Timeframe: From baseline (shortly before cesarean delivery) and 48 hours (range 36 to 60 hours) after cesarean delivery