DAISY Uterine Drain for Postpartum Hemorrhage
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather feedback on a new tool called the DAISY uterine drain, designed to manage heavy bleeding after childbirth, particularly during cesarean deliveries or certain surgical procedures. The focus is on how effectively doctors can place and use the drain. Women scheduled for a planned cesarean delivery or a surgical procedure called D & C (dilation and curettage), who have not already started labor, might be suitable for this trial. Participants should not have certain medical conditions, such as active infections or ongoing pregnancies, that could affect the procedure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for many women.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the DAISY uterine drain is safe for postpartum hemorrhage?
Research has shown that the DAISY Uterine Drain is designed to help manage fluid drainage after pelvic surgery. While specific data on its safety for this use is limited, similar devices generally aim to reduce surgery risks, such as bleeding. The trial focuses on gathering feedback from surgeons using it and observing its performance, making safety a primary concern. As this trial is in an early stage, safety is still under evaluation. Participants should consider this when deciding whether to join the study.12345
Why are researchers excited about this trial?
The DAISY Uterine Drain is unique because it offers a direct and potentially quicker method for managing postpartum hemorrhage compared to traditional treatments like uterotonics and surgical interventions. Unlike these standard options, which can involve systemic medications or invasive procedures, the DAISY Uterine Drain is a device that directly targets the uterus to drain excess blood efficiently. Researchers are excited about this treatment because it could provide a less invasive, faster-acting solution that reduces the need for more complex interventions, improving outcomes for new mothers.
What evidence suggests that the DAISY uterine drain is effective for postpartum hemorrhage?
Research shows that the DAISY uterine drain helps manage heavy bleeding after childbirth, known as postpartum hemorrhage. This trial will evaluate the DAISY uterine drain, which drains fluid through the cervix after pelvic surgery. Although limited data exist on its effectiveness in humans, researchers believe the drain could reduce heavy bleeding after a cesarean delivery. The drain aims to improve care for women experiencing complications like excessive bleeding after surgery. Initial studies collect feedback from doctors and patients to assess its practicality and potential benefits.12345
Who Is on the Research Team?
Tetsuya Kawakita, MD
Principal Investigator
Eastern Virginia Medical School
Are You a Good Fit for This Trial?
This trial is for pregnant women scheduled for a cesarean delivery (C-section) who haven't started active labor. They must consent to having the DAISY Uterine Drain placed during surgery and meet all other study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Placement of the DAISY uterine drain during cesarean delivery or D & C, followed by continuous suction for at least two hours post-surgery
Follow-up
Evaluation of uterine tone and device placement using manual palpation and abdominal ultrasound
Device Evaluation
Obstetrical surgeons complete a questionnaire evaluating the DAISY drain's ease of use and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- DAISY Uterine Drain
Trial Overview
The DAISy Uterine Drain device is being evaluated in this study. Obstetrical surgeons, considered 'users', will place the drain in participants during C-sections and provide feedback on its use and effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Twenty women in whom the Daisy Drain is placed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Raydiant Oximetry, Inc.
Lead Sponsor
Citations
NCT06219538 | DAISY Uterine Drain Device Evaluation
The DAISY drain is intended to provide a channel through the cervix for fluid drainage after pelvic surgery.
DAISY Uterine Drain Device Evaluation
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction.
DAISY Uterine Drain for Postpartum Hemorrhage
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical ...
DAISY Uterine Drain Device Evaluation
The study aims to evaluate the effectiveness of the DAISY drain in preventing postpartum hemorrhage (PPH) after cesarean delivery (CD).
DAISY Uterine Drain Device Evaluation (NCT06219538)
The DAISY Uterine Drain Device Evaluation study is looking to improve care for women who have complications after cesarean sections, such as excessive bleeding.
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