Uterine Drain Device for Cesarean Section
(RANI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Kira device, which monitors blood loss during and after c-sections. The device gently suctions blood from the uterus into a clear container, allowing doctors to easily see and measure it. The main goal is to assess the safety and effectiveness of this uterine drain device during c-sections. Women planning to have a c-section and able to provide informed consent might be suitable candidates for this trial. As an unphased trial, participants contribute to innovative research that may enhance surgical outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this device is safe for use during cesarean sections?
Research shows that the Kira device, a new tool for monitoring blood loss during c-sections, is in the early stages of testing with people. Although specific safety information is limited, similar devices have been used in hospitals. These tools help doctors see and measure blood loss, which is crucial during surgery. However, some devices used inside the uterus can sometimes cause hidden bleeding, where blood gathers above the device. The Kira device aims to address this issue. As the Kira device is still under study, safety information continues to be collected.12345
Why are researchers excited about this trial?
The Uterine Drain Device is unique because it offers a new way to assess blood loss immediately after a cesarean section. Traditional methods rely on visual estimation or weighing pads, which can be inaccurate. This device, however, provides a direct and precise measurement of blood loss, which can help doctors make quicker and more informed decisions about postpartum care. Researchers are excited about this approach because it could improve outcomes by identifying excessive bleeding much sooner than current methods allow.
What evidence suggests that this uterine drain device is effective for monitoring blood loss during c-sections?
Research has shown that monitoring blood loss during C-sections is crucial for patient safety. In this trial, all participants will join the interventional arm, where the uterine drain device, known as the Kira device, evaluates blood loss immediately after cesarean delivery. The Kira device aids by gently drawing blood from the uterus into a clear container, allowing the surgical team to easily see and measure the blood loss. Although specific data on the Kira device is not yet available, similar tools, such as balloon tamponades, have been about 85.9% successful in controlling blood loss after childbirth. This suggests that the Kira device could effectively measure blood loss during and after C-sections.23678
Are You a Good Fit for This Trial?
This trial is for adult individuals assigned female at birth, aged 18 or older, who can give informed consent and are undergoing a cesarean section. Specific details on who cannot participate are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
The Kira device is used to monitor blood loss during and immediately after cesarean deliveries
Follow-up
Participants are monitored for safety and effectiveness after the use of the device
What Are the Treatments Tested in This Trial?
Interventions
- Uterine Drain Device
Trial Overview
The Kira device is being tested in this study. It's a new medical tool designed to help the surgical team monitor blood loss during and after c-sections by suctioning blood into a container for measurement.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will be assigned to the interventional arm, in which the uterine drain is used to evaluate the blood loss immediately following cesarean delivery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lucie Medical Inc
Lead Sponsor
Citations
Efficacy of Intrauterine Bakri Balloon Tamponade in Cesarean ...
The overall success rate was 75% (48/64) for placenta previa patients. Previous cesarean section history, anterior placenta, peripartum platelet ...
KIRA Uterine Drain Device Evaluation- First-In- Human Study
The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor ...
Evidence-based surgical procedures to optimize ...
Opening the uterus using blunt instead of sharp dissection/expansion reduces operative time, probably reduces blood loss, and may reduce the ...
Intrauterine devices in the management of postpartum ...
There are a variety of balloon tamponade devices, both commercial and improvised, available for use. Efficacy of 85.9% was cited in a recent meta-analysis in ...
The Bakri balloon for the management of postpartum ...
In only one case was it inserted vaginally. The Bakri tamponade was effective in 22 cases (88%). There were three cases with failure: two patients needed an ...
Evidence-based surgical procedures to optimize caesarean ...
Current evidence suggests that several CS surgical procedures improve outcomes but also reveals a lack of or inconclusive evidence for many commonly used ...
DAISY Uterine Drain Device Evaluation
According to the American College of Obstetricians and Gynecologists (ACOG), between 54% and 93% of PPH-associated mortality may be preventable while 70-80% of ...
Efficacy and safety of intrauterine device placement during a ...
IUD placement during CS is effective in preventing unintended pregnancies within the first year after delivery, with operative outcomes unaffected.
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