A colourimetric early detectiondevice for premature rupture of membrane (PROM)

Premature rupture of membranes (PROM) and preterm PROM (pPROM) affect up to 10% and 4% of pregnancies globally, respectively, leading to significant maternal and fetal health risks if not detected and managed promptly. These risks include maternal chorioamnionitis, neonatal sepsis, umbilical cord prolapse, placental abruption, and preterm labor. Current detection methods, such as the Nitrazine test and immunoassays for biomarkers like PAMG-1 and IGFBP-1, are effective but are often costly, invasive, and depend on the mother's ability to identify abnormal vaginal discharge. Such dependency on patient recognition is problematic, especially in persistent low-volume leakage where symptoms are easily mistaken for normal discharge, delaying diagnosis and treatment. These challenges are further compounded in rural or underserved areas, where limited access to healthcare can delay diagnosis and increase risks. Our research aims to develop a novel colorimetric detection system that functions as a vaginal insert for the early identification of premature rupture of membranes (PROM) and preterm PROM (pPROM). This insert is specifically designed to distinguish amniotic fluid from other vaginal discharges, offering an at-home, minimally invasive solution that integrates into a patient’s daily routine. By utilizing a pH-sensitive polymer, the device reacts to the presence of amniotic fluid by releasing a biocompatible dye, causing a visible color change in vaginal discharge. This allows for early detection, even with small leaks, enabling patients to seek timely medical care without frequent clinical visits. The system leverages the design of pessary devices, which are already widely used by pregnant women for long-term use, ensuring comfort and improving patient compliance. Placing the device close to the uterus maximizes contact with amniotic fluid while minimizing interference from other secretions. The device uses FDA-approved materials to ensure biocompatibility and safety for both mother and fetus. In contrast to costly and time-consuming biomarker assays, this solution provides a simple, cost-effective alternative by utilizing the pH difference between amniotic fluid and vaginal discharge. Ultimately, this system offers a user-friendly, accessible, and highly sensitive method to detect PROM and pPROM, improving maternal and fetal health outcomes, especially in low-resource settings. Aim 1: Optimize the formulation of a pH-responsive polymer with additives to ensure stability in an acidic vaginal environment while maintaining high sensitivity to amniotic fluid. Aim 2: Refine device designs, including geometric configurations and material placement, to enhance detection sensitivity and specificity, minimizing false positives and negatives. Aim 3: Assess the biocompatibility, stability, and effectiveness (i.e., sensitivity and selectivity) of the prototype devices for detecting amniotic fluid leakage using a mouse model Project Number: 1R21HD119469-01A1 | Fiscal Year: 2026 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Yuhan Lee | Institution: BRIGHAM AND WOMEN'S HOSPITAL, BOSTON, MA | Award Amount: $485,930 | Activity Code: R21 | Study Section: Instrumentation and Systems Development Study Section[ISD] View on NIH RePORTER: https://reporter.nih.gov/project-details/11373861