Uterine Drain Device for Cesarean Section

(RANI 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.

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.

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

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.

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