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New balloon method aims to stop Post-C-Section bleeding in High-Risk moms

NCT ID NCT07019623

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospital Zurich

    RECRUITING

    Zurich, 8091, Switzerland

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