Overview
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.
Eligibility
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
