The Study Cohort
The B-WELL-MOM study was established by Dr. Pauline Mendola at the National Institute of Child Health and Human Development, National Institutes of Health. B-WELL-MOM is an observational cohort study designed to evaluate biologic mechanisms (allergy, genetic, immunologic) underlying changes in asthma control during pregnancy. The cohort will be assembled over 2.5 years in 2 clinical sites: the University of Alabama at Birmingham and Northwestern University in Chicago, IL. The overall objective of this study is to evaluate predictors of asthma control variability during pregnancy accounting for changes in lung function and markers of inflammation associated with pregnancy in non-asthmatics. The primary study aims are:
Specific Aim 1: To assess whether atopy status, measured by total IgE at enrollment, predicts asthma control variability during pregnancy.
Specific Aim 2: To evaluate whether atopy status is associated with additional decrements in lung function and increased inflammation in pregnancy among women with asthma after considering the role of atopy in function among non-asthmatics.
Specific Aim 3: To evaluate the impact of Treg levels and its regulation by Foxp3 on asthma control variability during pregnancy.
Specific Aim 4: To evaluate whether changes in lung function and inflammation in all women will be associated with higher exposure to poor ambient air quality (traffic, commuting, ambient measures) and lower estimates of dietary antioxidants.
For the purposes of B-WELL-Mom, women with asthma will be in the “well controlled” group if their score on the Asthma Control Test (see table below) is greater than or equal to 20 (target n=200). Lower scoring women with asthma will be in the “poorly controlled” group (target n=200). The third (control) group will be comprised of women with no history of asthma, no current asthma symptoms or asthma medication use (target n=100).
Table: Assessing asthma control in adults
| Components of Control/Impairment | Well-Controlled | Not Well-Controlled | Very Poorly Controlled |
|---|---|---|---|
| Symptoms | ≤2 days/week | >2 days/week | Throughout the day |
| Nighttime awakening | ≤2x/month | >1-3x/week | ≥4x/week |
| Interference with normal activity | None | >Some limitation | Extremely limited |
| Short-acting beta agonist use for symptom control (not for exercise induced asthma) | ≤2 days/week | >2 days/week | Several times per day |
| FEV1 or peak flow | >80% predicted value | 60-80% predicted value | <60% predicted value |
| Validated asthma questionnaire scores Asthma Control Test | ≥20 | 16-19 | ≤15 |
Information Collected
The information collected and their collection time is described HERE.