New balloon method aims to stop Post-C-Section bleeding in High-Risk moms
NCT ID NCT07019623
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new method called U-CaVIT, which uses a balloon placed in the uterus to prevent severe bleeding after a C-section in women at high risk. About 70 participants will either get standard care or standard care plus the balloon. The goal is to see if the balloon reduces blood loss and is safe and easy to use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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University Hospital Zurich
RECRUITINGZurich, 8091, Switzerland
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