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

Launched by CHRISTIAN HASLINGER · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method called U-CaVIT, which uses a special balloon catheter to help prevent a serious condition known as atonic postpartum hemorrhage (PPH) in women who are at high risk during cesarean deliveries. Atonic PPH occurs when the uterus doesn't contract effectively after childbirth, leading to excessive bleeding. The trial is taking place at the University Hospital of Zurich, where the U-CaVIT method has been found to be user-friendly and effective for treating this condition, especially when traditional treatments don’t work.

To participate in this study, women must be at least 18 years old, be pregnant for at least 34 weeks, and have a planned cesarean delivery. They also need to be considered at high risk for PPH due to factors like previous instances of postpartum hemorrhage, obesity, or having had many previous births. Participants will receive the U-CaVIT treatment during their cesarean section and will be monitored for safety and effectiveness. It’s important for potential participants to know that certain health conditions or situations may exclude them from the study, so a careful assessment will be done before they can join.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent
• • Maternal age ≥18 years
• • Gestational age ≥34+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)
• • 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
• • Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin
• • Previous MMC-repair (myelomeningocele-repair)
• • Clinical diagnosis of chorioamnionitis, sepsis
• • Allergy to any component of the device
• • 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 g/L
• The following exclusion criteria will only be checked during the intra-operative assessment before randomization takes place:
• • Cervix deemed too stiff and/or stenotic for U-CaVIT application, judged by the surgeon during the intra-operative assessment.
• • Unexpected intraoperative findings incompatible with application of U-CaVIT (see above described clinical situations in exclusion criteria, in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated).