fFN Study – Women Less than 22 Weeks Pregnant

STUDY BASICS

Are you less than 22 weeks pregnant and considered to be at high-risk for giving birth prematurely (due to previous premature birth, twin pregnancy, or other risk factor)? If so, you may be able to participate in a 1-visit research study to help find out if measuring a protein called fFN in vaginal fluid can help identify which women are likely to give birth early. Compensation provided.

STUDY PURPOSE

Babies born before the 37th week of pregnancy are at risk for various health problems, but identifying which women are likely to give birth too early can be a challenge. However, research has shown that the presence of a protein called fetal fibronectin (fFN) in vaginal fluid during weeks 22-35 may be a sign that a woman’s body is preparing to deliver early. Fetal fibronectin (fFN) is a glue-like substance that holds the developing baby in place in the womb throughout pregnancy. The purpose of this study is to find out if measuring fFN in the vaginal fluid samples of women who are between 16-22 weeks pregnant can help identify which women are likely to give birth prematurely. Researchers hope their findings will lead to better ways to assess pregnant women in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women who are between 16-22 weeks pregnant
• Considered at risk for giving birth prematurely as indicated by at least one of the following: - You have had a previous preterm birth (this means that you have delivered a baby between 20-37 weeks) - You have a short cervical length (will be confirmed by ultrasound) - You are currently pregnant with twins - You had a cervical stitch (also known as cervical cerclage) in a prior pregnancy - You had a prior surgical procedure in which a cone-shaped tissue sample from the cervix was removed for examination (also called a cone biopsy) - You received prior treatment for abnormal cells on the cervix

WHAT PARTICIPANTS CAN EXPECT

Participation involves one in-person visit during which the study doctor will use a swab to collect a vaginal fluid sample. Participants will also answer questions about their current pregnancy and any past pregnancies. No blood is drawn during this study.