DAISY Uterine Drain Device Evaluation

Launched by RAYDIANT OXIMETRY, INC. · Jan 12, 2024

Keywords

ClinConnect Summary

The DAISY Uterine Drain Device Evaluation study is looking to improve care for women who have complications after cesarean sections, such as excessive bleeding. The main goal of this trial is to gather feedback from doctors who will use a special uterine drain to help manage these issues. This study involves pregnant women who are having planned cesarean deliveries and have agreed to participate.

To be eligible for this study, women must be undergoing a cesarean delivery for reasons not related to the trial. However, certain conditions like ongoing pregnancies or infections may prevent someone from participating. If a woman joins the study, she can expect to have the uterine drain placed during her surgery, and doctors will monitor its use and effectiveness. This trial is important because it aims to enhance the treatment options available for managing postpartum bleeding and improve overall care during cesarean deliveries.

Gender

FEMALE

Eligibility 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