PROMISE
Official Title
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life (PROMISE)Purpose
The purpose of this study is to find out more about how health and exposures during pregnancy, such as having an infection, diet and growth may impact later risk of islet autoimmunity in the
child. We are also interested in finding out more about why having a father or sibling with type 1 diabetes increases risk of autoimmunity in the child than having a mother with type 1 diabetes.
Could this study be right for you?
Inclusion:
Pregnant women:
- who is between 8-24 weeks gestation with a singleton pregnancy
- have had type 1 diabetes for at least 12 months, or the father of the baby or a full sibling of the baby has type 1 diabetes
- is 18 years of age or older
- is willing to have blood collected and to complete questionnaires about prenatal exposures once per trimester during their pregnancy (up to 3 visits) and up to 12
weeks after they deliver their baby
- is willing to have their baby screened for genetic risk for type 1 diabetes, to complete online questionnaires, and to have their child followed for measurement
of islet autoimmunity according to the determined risk for type 1 diabetes, through 5-7 years of age.
o If low risk, two screenings: the first at 2 years of age and the second between 5-7 years of age
o If high risk, five screenings: every six months through 2 years of age, and one between 5-7 years of age
The father of the baby will also be asked to complete one visit during pregnancy but it is not mandatory.
Exclusion:
- Multiple Gestation pregnancy
- Mother unable to consent due to intellectual impairment
- Fetus with known medical issue that would affect study participation
- Surrogate / gestational mothers who are not biologically related to offspring they are carrying