U-CaVIT versus standard care to prevent atonic postpartum bleeding after cesarean in high-risk women
Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.
This pilot will try the U-CaVIT method—placing a Rüsch® silicone balloon catheter with vacuum tamponade during planned cesarean—to see if it prevents heavy postpartum bleeding in women at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT07019623 on ClinicalTrials.gov |
What this trial studies
This pilot interventional protocol applies the U-CaVIT method using the Rüsch® Brillant silicone balloon catheter for intrauterine vacuum-induced tamponade during planned cesarean deliveries in women identified as high risk for uterine atony. The study will record performance, safety, and feasibility measures and compare the U-CaVIT approach to the current standard of care for prevention of atonic postpartum hemorrhage. Placement is performed intraoperatively with ultrasonographic guidance as needed, and outcomes include blood loss, need for additional interventions, and device-related adverse events. Eligible participants are adults with gestational age ≥30+0 weeks undergoing planned cesarean who meet predefined high-risk criteria, while emergency cesareans and those unable to consent are excluded.
Who should consider this trial
Good fit: Adults (≥18 years) with a planned cesarean at ≥30 weeks who are considered high risk for PPH (for example prior PPH, BMI ≥30, parity ≥4, age ≥45, multiple gestation, polyhydramnios, or suspected fetal macrosomia) and who can give informed consent in German or English.
Not a fit: Women having vaginal delivery, undergoing emergency cesarean, those under 30 weeks' gestation, not meeting high‑risk criteria, or those unable to consent or communicate in the required languages are not likely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, U-CaVIT could reduce severe postpartum bleeding, lower the need for transfusions or surgical interventions, and help preserve the uterus.
How similar studies have performed: Intrauterine balloon tamponade (for example the Bakri balloon) is an established treatment for PPH, but proactively using a urological Rüsch® balloon as U-CaVIT for prevention at cesarean is relatively novel and supported mainly by local observational experience rather than large randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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: 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 * Submucous or intramural uterine fibroids which are buldging into the uterine cavity * Deep endometriosis \[16, 17\] * Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin * Previous MMC-repair (myelomeningocele-repair) * Clinical diagnosis of chorioamnionitis, sepsis * Known allergy to silicone * Known and proven diagnosis of bleeding disorder or thrombophilia * Known thrombocytopenia during second half of pregnancy with thrombocytes \< 100 G/L * Known anemia during second half of pregnancy with Hb\<80
Where this trial is running
Zurich
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Prof. Dr. med. Christian Haslinger, MD — University Hospital Zürich, Switzerland
- Study coordinator: Christian Prof. Dr. med. Haslinger, MD
- Email: Christian.haslinger@usz.ch
- Phone: +41 43 253 75 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.