Evaluation of the DAISY uterine drain for cesarean section complications
DAISY Uterine Drain: Device Evaluation With Standard Wall Suction
This study is testing a new uterine drain to see if it helps prevent complications from bleeding after cesarean sections and other related procedures for pregnant women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Raydiant Oximetry, Inc. Industry-sponsored |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT06219538 on ClinicalTrials.gov |
What this trial studies
This study aims to gather user feedback on the DAISY uterine drain, which is designed to manage postpartum hemorrhage by facilitating fluid drainage after cesarean deliveries or dilation and curettage procedures. Obstetrical surgeons will place the drain and observe its effectiveness in preventing complications associated with uterine atony. Participants will be pregnant women undergoing these procedures who meet specific inclusion criteria. The study focuses on improving maternal outcomes by addressing a leading cause of maternal mortality.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women scheduled for a planned cesarean delivery or dilation and curettage who have not entered active labor.
Not a fit: Patients with known intrauterine or cervical pathologies, ongoing pregnancies, or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the incidence of postpartum hemorrhage and improve maternal safety during and after cesarean deliveries.
How similar studies have performed: While the approach of using a uterine drain is not widely tested, the focus on addressing postpartum hemorrhage through innovative mechanical means shows promise based on existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participants consist of women undergoing planned CD or D \& C for reasons unrelated to this study. Exclusion Criteria: * Known intrauterine or cervical pathology that would interfere with device placement and/or use * Ongoing intrauterine pregnancy * Untreated uterine rupture * Unresolved uterine inversion * Current cervical cancer * Current purulent infection of vagina, cervix, or uterus * Retained products of conception * Arterial bleeding requiring surgical or angiographic embolization * Indication for hysterectomy * Lack of study consent or unable to provide informed consent, * Plan for IUD placement after D \& C, * Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures
Where this trial is running
Norfolk, Virginia
- Eastern Virginia Medical School — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Tetsuya Kawakita, MD — Eastern Virginia Medical School
- Study coordinator: Kristin Ayers, MPH
- Email: ayerskl@evms.edu
- Phone: 757.446.0529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.