The TOPS study

STUDY BASICS

Are you between 16-23 weeks pregnant and planning on delivering at Magee? Do you have a short cervix? If so, you may be able to participate in a research study to help find out if the Arabin cervical pessary can prevent preterm birth in women who have a short cervix. Compensation provided.

STUDY PURPOSE

Women who have a short cervix (the lower, narrow part of the womb) are more likely to deliver their babies preterm (before 37 weeks of pregnancy). Babies born preterm can have serious, life-threatening health problems. The purpose of this research study is to find out if a device called a pessary lowers the risk of preterm birth in women with a short cervix. A pessary is a round, soft silicone device that goes around the cervix to give the cervix support.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women less than 24 weeks pregnant with one baby
• Planning to deliver at Magee Women’s Hospital
• Have been told that they have a short cervix by their physician (after having a vaginal ultrasound)

WHAT PARTICIPANTS CAN EXPECT

Participation involves up to 7 visits (about once every 4 weeks). During visit 1, participants will have a physical exam and will be randomized (like a flip of a coin) to either the pessary group or a group that will receive routine prenatal care from their regular physician. If randomized to the pessary group, a pessary will be placed around the cervix. Following visit 1, participants will be seen for monthly visits during which they will answer questions about symptoms and treatment. Participants in the pessary group will also be asked questions about their experience with the pessary. A vaginal fluid sample will be collected on 2 occasions. At the final visit, the pessary device will be removed from participants randomized to that group.