Data Management
Patient data forms were handled by the clinical midwives or study staff only, all of whom
completed training in research ethics and patient confidentiality. Data forms were collected
from the hospital several times per week, and entered into a database written especially for this
project. The Study Administrator and principal investigator also performed bi-annual chart
reviews to retrieve limited data from the 6-week postpartum office visit. The database for the
study contained range and frequency checks to reduce the likelihood of data entry errors. After
data from 400 births were entered into the database, a 10% random sample of paper records
was systematically compared with the computer-entered data, and errors were found to be
fewer than one per 1,000 data items.