DAISY Uterine Drain for Postpartum Hemorrhage
Trial Summary
What is the purpose of this trial?
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 surgeons as "users" and the patients in whom the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD) or D \& C, who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.
Research Team
Tetsuya Kawakita, MD
Principal Investigator
Eastern Virginia Medical School
Eligibility Criteria
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
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
Treatment Details
Interventions
- DAISY Uterine Drain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Raydiant Oximetry, Inc.
Lead Sponsor