A low-cost, rapid swab test to help prevent and better manage cases of prematurity
CHALLENGE
Pre-labor rupture of fetal membranes (PROM) and premature, pre-labor rupture of fetal membranes (P-PROM) represent a life-threatening pregnancy complication that requires early detection and management. Occurring in up to 7% of pregnancies, PROM happens when the amniotic sac is breached before the onset of labor, causing amniotic fluid to leak into the vaginal – leading to a 6x higher rate of neonatal sepsis and contributing to 30-40% of premature births.
SOLUTION
The Amnicator is an FDA- and CE-certified screening tool for quick, cost-effective, and non-invasive detection of amniotic fluid in the vagina, enabling quicker time to care and preventing unnecessary or expensive diagnostic testing. The Amnicator is designed to detect a change in pH level from the leakage of amniotic fluid, providing color-coded results in real-time to help inform clinical decision-making.
KEY FEATURES
- Nitrazine-based swab test providing color-coded results within 30 seconds
- Non-invasive method that can be used by a health provider during speculum analysis
- Aligned with most international and national PROM guidelines
- Stable at room temperature with a shelf-life of 2 years
- No laboratory required
