What is the P3 Study? The P3 Study is also known as the Path to Prevent Preterm Birth Study. This study collects detailed data and biologic samples. It will help researchers to understand why some women have more than one preterm birth. For example, information from this study may help doctors know which medications or medical care will work best to help women deliver full term.
The P3 study is funded by R01-MD011609 (National Institutes of Health - Minority Health & Health Disparities).
Why am I being asked to participate? You are being asked to be in the study because you have had a previous preterm birth. We are also asking some women who have delivered only full term babies to participate.
What will I have to do? We will discuss the study with you in detail. If you agree to participate, you will review an online consent form and HIPAA form in detail.
Once you agree to participate and sign the consent form and the HIPAA form, we will ask you additional questions about your medical history and pregnancy history. We will also collect an extra sample of your blood up to twice during pregnancy and at delivery at the time of routine clinical lab draws. We will obtain samples from the placenta/ umbilical cord, and cord blood after delivery (this tissue is normally discarded). We will ask you to complete some surveys about stress, your relationships now and during your childhood, your daily activities, and symptoms you are experiencing.
Your study visits:
Visit 1: up to 20 weeks - complete interview questions with research staff and surveys by email; provide blood sample, vaginal swabs, urine sample, wear wrist band for environmental exposure assessment (5-7 days)
Visit 2: 18-24 weeks - complete interview questions with research staff and surveys by email ; provide blood sample, vaginal swabs, urine sample, wear wrist band for environmental exposure assessment (5-7 days)
Survey visit 1: 24-30 weeks - complete surveys by email only
Survey visit 2: 28-34 weeks - complete surveys by email only
Delivery: blood sample (mom), cord blood samples, placental & membrane samples only (these tissues are typically discarded). There are no surveys or interview questions at delivery.
There are no study-only visits to the hospital or clinic. We will attempt to obtain blood samples at the time of a clinical sample but there may be times when we obtain blood at another time, for research purposes only.
Are there any risks? Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
Will it cost me anything to be in the study? There are no costs to participate.
Will I be paid to participate? You will receive a $25 gift card for each of the 5 visits above. There are a up to 5 total study visits, so the maximum you will receive is $125. Additionally, you will receive parking vouchers for your on-site visits if they are at UNC-main campus and require