VCU Pregnancy Study –Online Information
What is this study about?
Preterm births occur in approximately 13-18% of births in the U.S and are a major contributor to perinatal and infant mortality. We know that the likely hood of having a preterm birth is largely due to our genes. However, we also know that different environmental factors, like stress, can have a major impact on pregnancy health. What we are trying to understand is how these environmental factors “get under the skin” to affect biological processes like the timing of birth. We hope that we can ultimately use this information to develop better diagnostic and preventive treatments for preterm births.
Who can participate?
African American and European women who are self-identified as non-Hispanic and non-Middle Eastern white or black are eligible to participate. We are looking for women who are between the ages of 18 and 40, who are less than sixteen weeks pregnant (still in the first trimester) and who are expecting only one baby (not twins or multiplets).
What does the study involve?
You will complete four sessions throughout your pregnancy at VCU Medical Center. During these sessions, we will ask you questions about your education and racial background, about the environment you live in, such as aspects of your neighborhood or life stressors, and also about ways you feel about a variety of topics like your pregnancy and how you cope with stress. The baseline session will last approximately 2 hours while each follow-up session will last about 1 hour.
We will also collect 8 mL of blood (less than 2 teaspoons) at the baseline session and 4 mL of blood (about 1 teaspoon) at each follow-up session. A trained Research Nurse will conduct the blood draw, typically from a vein in your arm. To the best of our abilities, these sessions will be scheduled to correspond with your existing OB/GYN visits, or at whatever time is most convenient for you.
Finally, at the time of your child’s birth, a member of our research staff will collect cord blood (taken from the umbilical cord attached to the placenta that is usually discarded). These materials will allow the research team to assess for changes in biological factors that may be important indicators of pregnancy health.
Your participation is completely voluntary and you are allowed to leave the study at any point.
Will I be compensated for my time?
You can earn up to $250 in compensation for participating in this study. You will receive a $50 gift certificate to Wal-Mart after each of the four sessions session and one once your baby’s afterbirth materials have been collected. You are allowed to skip any of the questions asked of you during the sessions without it affecting your compensation.
How do you keep the data confidential?
All paper-based records are kept in a secure location that can only be accessed by authorized study personnel. All electronic records are only accessible by researchers through use of access controls and encryption. Names and other individually identifying information are removed before giving the data to researchers for analysis and are coded with a key and kept in a separate, secure location.