We examined data from the ESCF that documented the clinical course and treatment of 24,000 individuals with CF living in the United States and Canada who were followed up for up to 9 years. Sites providing care for > 10 patients with a documented diagnosis of CF who elected to participate obtained patient consent, as required by local investigational review boards, and collected data, including those on specific pulmonary and nutritional therapies for each patient encounter. All patient therapy decisions were made at the discretion of the local care providers, although the use of guidelines developed by the Cystic Fibrosis Foundation was encouraged. With the analyses reported here, we sought to characterize health outcomes and CF-related therapies in pregnant women with CF. read
We considered all women between 14 and 40 years of age who had at least 10 encounters recorded in the ESCF. Because the database does not capture the dates of the last menstrual period, delivery, or termination of pregnancy and does not record fetal outcomes, pregnancy was identified if a woman was reported as being pregnant on at least two visits > 30 days apart. The clinic visit prior to the first visit recording the pregnancy was considered to be the index visit and was required to occur within 180 days before the first pregnancy visit. We then considered the 18 months of time up to and including the index visit to be the baseline period; the 12 months of time following the index visit as the during pregnancy period; and the subsequent 18 months as the follow-up period (Fig 1). In addition to the two pregnancy visits occurring at least 30 days apart, patients were required to have an index visit and at least one visit in the follow-up period. For women with multiple pregnancies, defined by a span of > 300 days from the first to the last reported visit in which the patient was pregnant, the first qualifying pregnancy was included. A qualifying pregnancy required that the woman not be pregnant for 18 months before the pregnant visit and for 18 months after the pregnancy period was completed.
Figure 1. Timeline and required visits during the three periods of the study (baseline, during pregnancy, and follow-up).