Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Condition: Cystic Fibrosis; Contraception
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The long-term goal is to study the safety and effectiveness of hormonal contraception for
      women with cystic fibrosis (CF) and contribute to national guidelines that the Cystic
      Fibrosis Foundation and the Centers for Disease Control and Prevention (CDC) provide to
      clinicians. The study objectives are to determine whether hormonal contraceptive methods
      improve overall pulmonary health, worsen CF-related disease or CF liver disease, or are
      effective against unwanted pregnancy with concomitant CF transmembrane conductance regulator
      (CFTR) modulator use. The hypothesis is that hormonal contraceptive methods are safe and do
      not worsen CF-related complications over time,improve FEV-1 when compared to non-hormonal
      users, and oral birth control methods with CFTR modulator use.
    

Detailed description: 
      This is a non-randomized, non-interventional, observational cohort design among
      reproductive-aged women (ages 18-45 years) with CF. The investigators intend to ask about 625
      female participants to provide information about their types of past contraceptive use from
      2008 through the most recent data available from CFFPR (2018 or 2019). Before initiating our
      trial among up to 625 respondents, the investigators intend to pre-test the survey questions
      on our self-respondent questionnaire among as many as 50 women with and without CF through
      CFF Community Voice, the Cystic Fibrosis Research, Inc. (CFRI), and the Cystic Fibrosis
      Reproductive and Sexual Health Collaborative (CFReSHC). Pre-testing the study survey
      questions will help ensure contraceptive, pregnancy, and other reproductive health data from
      respondents for the larger phase of this study are as complete and accurate as possible. Once
      the survey has been piloted and revised accordingly, the investigators will collect past
      contraceptive, pregnancy and other reproductive health data from up to 625 women at 10
      different CF centers. The investigators may over-sample by 25 participants because it is
      possible that some participants from UW, UTSW and National Jewish may have participated an
      earlier published study related to contraceptive use and CFFPR. Recruiting through the CF
      centers will help ensure that women with a confirmed diagnosis of CF respond to the finalized
      survey. The investigators will link respondent self-reported contraceptive and reproductive
      health data with CFFPR clinical data. The investigators will ask for EMR data from the 10
      different CF centers to validate DXA scan results with findings regarding osteoporosis,
      osteopenia, and bone fracture in the CFFPR. The investigators plan to randomly select about
      10 consented subjects from each of the centers for the EMR DXA scan chart review. Because of
      the need to link questionnaires and clinical case report forms correctly to the same women
      with CF in the CFFPR clinical data, this study requests identifiable information, including
      the CFFPR member ID number.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with cystic fibrosis who have not used any form of contraception, or who have used
        contraception for protection against pregnancy or for treatment of dysmenorrhea, pelvic
        pain, abnormally heavy or prolonged menstrual bleeding, endometriosis, acne or amenorrhea.
      
Keywords: birth control; contraception; cystic fibrosis; bone mineral density; CFTR modulator; women