NIH-funded research R21 grant

Colorimetric at-home test to detect premature rupture of membranes (PROM)

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

Funded at Brigham and Women's Hospital · NIH-11373861 · Data updated 2026-11-12

A simple vaginal insert changes color to indicate the presence of amniotic fluid, helping detect PROM or preterm PROM early and at home.

More Premature research and trials

Quick facts

Grant typeR21 grant
Study typeNIH-funded research
Funding institutionBrigham and Women's Hospital
NIH-funded
Lab location1 site (Boston, United States)
Project startJune 1, 2026
Project endMay 31, 2028
Funding year2026
Award (this year)$485,930
NIH project number1R21HD119469-01A1
Project IDNIH-11373861 on NIH RePORTER

Who could benefit from this research

Could help

Pregnant individuals at risk for PROM who may benefit from an at-home preliminary indication of amniotic fluid leakage.

Less likely to help

Individuals without PROM risk or those who are not experiencing vaginal discharge related to membranes rupture.

What this research studies

This project aims to create an easy-to-use vaginal insert that reacts to amniotic fluid with a visible color change, enabling women to identify PROM early. The device uses a pH-sensitive polymer and biocompatible dye to provide a clear signal in vaginal discharge. It is designed to be low-cost, minimally invasive, and suitable for home use, with the goal of improving access to timely diagnosis, especially in rural or underserved settings.

Why it matters

Potential benefit: If successful, this technology could enable earlier detection of PROM, potentially reducing maternal and neonatal complications by prompting timely medical care.

How similar studies have gone: Existing tests validate amniotic-fluid biomarkers, but this device offers a user-friendly at-home colorimetric approach which is novel in this context.

Where this research is happening

  • Brigham and Women's Hospital
    Boston, United States
    Active

Researchers

  • Principal investigator: Lee, Yuhan — Brigham and Women's Hospital
  • Study coordinator: Lee, Yuhan

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.