Helping women gain control of their asthma.
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Ancillary Studies

In addition to the main study, participants are asked to participate in one of the following optional sub-studies:

Local mobility study

During the consent process, participants are asked whether or not they want to participate in mobile tracking to estimate pollution exposure. The app allows the data coordinating center (DCC) to track the location and movement of the participant during a four-week period (during each trimester and one week after delivery). The participant’s location is recorded at specific times and the participants have to grant permission for the information to be sent to the research team using the tablet. Participants are allowed to leave and come back to tracking any time they wish; they only have to change the setting on the app or inform their study coordinator. The participant’s location information is coded so that it remains confidential.

Air pollution study

Subjects of the B-Well-Mom Study will be asked if they want to participate in the Air Pollution Substudy. The Air Pollution Substudy aims to collect two full days of personal exposure data and two full days of indoor levels from each participant.

Table 1. Study Subgroups of the Air Pollution Substudy Participants

Monitoring subgroups Sequential Parallel
Description of monitoring design One monitor box requires personal monitoring for 48 hours and then indoor monitoring for another 48 hours. The MicroPEM™ and CairClip are used for personal and indoor monitoring. The Ogawa badge with a blue dot is used for personal monitoring and the other badge with a yellow dot is used for indoor monitoring. Requires two monitor boxes. Clinic staff will mark the extra two Ogawa badges from the second box as “do not use” and leave them in the box to return to RTI. Yellow dots will also need to be applied to the Box 2 MicroPEM™ and CairClip to identify them as indoor monitoring devices.
Number of monitoring devices to be used
  • 1 MicroPEM™ for PM
  • 1 CairClip for NO2
  • 2 Ogawa badges for O3 from 1 monitoring device set
  • 2 MicroPEM™ for PM
  • 2 CairClip for NO2
  • 2 Ogawa badges for O3 from 2 monitoring device sets
    (two Ogawa badges from one of the two boxes will not be used and returned to RTI)
Total monitoring period 96 hours (48 hours for personal monitoring; another 48 hours for indoor monitoring) 48 hours (concurrent personal and indoor monitoring)

The purpose of the Air Pollution Substudy is to see the difference in immune systems of asthmatic and non-asthmatic women when exposed to indoor and outdoor pollutants. The study team is interested in particulate matter 2.5 micrometers or smaller (PM2.5), nitrogen dioxide (NO2), and ozone (O3) because these are known to be asthma and respiratory triggers. There are three small machines for the study that can monitor these pollutants.

PM2.5 Monitoring using MicroPEM™

The MicroPEM™ measures PM in the air and detects if the participant actually wears the device. The MicroPEM™ is very quiet and lightweight.

Nitrogen Dioxide Monitoring using CairClip

The CairClip takes samples of the air. The CairClip is a lightweight, rechargeable device. It last up to 36 hours on a full charge. The monitor measures NO2 and this information can be downloaded onto a PC.

Ozone Monitoring using Ogawa Badges

The Ogawa Badge is ideal for monitoring ozone indoors and outdoors. To use the badge, remove it from the airtight bag and put it back in the bag when you are finished.