What:
The Bill & Melinda Gates Foundation awarded a $100,000 Grand Challenges Explorations grant to Scott Sullivan, M.D. The funds will help with the development of a vaginal pessary that will extract a 17-alpha hydroxyprogesterone caproate (17-OHP) during a 20-week period to prevent preterm delivery in low-resource settings. The device would be inexpensive, easily shipped and could be inserted either by patients themselves or by a health attendant, if available.

Dr. Scott Sullivan, at the Prenatal Wellness Center, with models of pessaries, which are used for uterine prolapse. He is developing a novel pessary with fiber-eluting materials to prevent premature births.

The Need:
A pessary provides structural support to the maternal cervix and a steady concentration of 17-OHP throughout the critical weeks of pregnancy where inflammation and cervical shortening can lead to preterm delivery.

The Researcher:
Sullivan, M.D., is an associate professor of maternal-fetal medicine and the director of residency training and co-director of the Premature Birth Prevention Clinic.

"We are grateful to be able to develop this project that may reduce preterm birth in areas of the greatest need. We are also grateful that we may be able to bring the newest treatments to low resource settings through the use of bioengineering and are fortunate to be able to leverage the expertise at Clemson and MUSC for this grant."

How it Works
This device allows the timed release of 17-OHP directly to the maternal cervix, rather than the traditional weekly intra-muscular injections or a daily vaginal tablet. This is particularly advantageous in low-resource settings where health care providers may not be available to give injections and a steady supply of medication may be difficult to obtain.

An artist's rendering of the proposed device. The cut-away demonstrates the inner core of reloadable fiber coated with progesterone. The permanent outer core provides support and positional benefit to the pregnant cervix.

Potential Impact:
If the pessary proves to be well tolerated and to work as expected, the next step would include a comparative trial between the device and conventional injectable or vaginal medication. Overall performance in reducing preterm birth would be the primary outcome with particular attention to differences in compliance and completion of recommended therapy. This trial would be completed in either a developing country or in a critically underserved, high-risk area of the United States.