What is the P3-Remote 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. We hope that this research will help improve outcomes for moms and babies in North Carolina and beyond!
We have been working on the P3 study for more than 3 years. We are now starting the P3-Remote study to enable us to continue this important work during social distancing and the coronavirus pandemic. The P3-Remote study will recruit women ONLY when social distancing is required / we are not permitted to recruit women or interact with research participants in person.
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 call to 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:
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks? Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. 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 be paid $20 in gift card for each visit and for each survey visit you complete.
There are a up to 4 total study visits, so the maximum you will receive is $80.
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. We hope that this research will help improve outcomes for moms and babies in North Carolina and beyond!
We have been working on the P3 study for more than 3 years. We are now starting the P3-Remote study to enable us to continue this important work during social distancing and the coronavirus pandemic. The P3-Remote study will recruit women ONLY when social distancing is required / we are not permitted to recruit women or interact with research participants in person.
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 call to 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
- Visit 2: 18-24 weeks - complete interview questions with research staff and surveys by email
- Survey visit 1: 24-30 weeks - complete surveys by email only
- Survey visit 2: 28-34 weeks - complete surveys by email only
- Delivery: samples only (no surveys or interview questions)
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks? Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. 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 be paid $20 in gift card for each visit and for each survey visit you complete.
There are a up to 4 total study visits, so the maximum you will receive is $80.