Cesarean Delivery Procedures
Conditions
Keywords
cesarean delivery, surgical drain, blood loss measurement
Brief summary
The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor blood loss during and immediately after cesarean deliveries (c-sections). This study will assess the safety of the device and the device's ability to gently suction blood from the uterus into a clear container where it can be seen and measured by the surgical team.
Interventions
DEVICEUterine drain for use in cesarean section
The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.
Sponsors
Lucie Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult, sex female at birth, age 18 years or older at the time of consent. * Able to understand and provide informed consent to participate in the study. * Undergoing c-section
Exclusion criteria
* Ongoing intrauterine pregnancy * Untreated uterine rupture * Unresolved uterine inversion * Known uterine, cervical, or vaginal anomaly that would prohibit device placement. * Placenta abnormality including a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal. * Diagnosis of coagulopathy * Current cervical cancer * Current purulent infection of vagina, cervix or uterus. * History of allergy to device materials (thermoplastic elastomers (TPE), acrylonitirile butadiene styrene plastic (ABS), cyanoacrylate) * Lack of study consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity and seriousness of device related Adverse Events (ADE's) | Measured at study exit, approximately 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use questionnaire | Within 2 weeks of study completion | Likert type scale with higher scores indicating agreement with the statement. |
| Cumulative blood loss | Measured through 24 hours from time of delivery | — |
Countries
United States
Outcome results
None listed