Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Contraception

• Registration Number: NCT04568980
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2020-09-30
• Primary Completion: 2022-05-02
• Study Completion: 2022-12-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 562

Inclusion Criteria

• Women with cystic fibrosis age 18-45 years
• Enrolled as a participant of the Cystic Fibrosis Foundation Patient Registry
• Working email address
• Can read written English

Read More

Exclusion Criteria

• History of organ transplant
• Does not have a phone number or email address in their record
• <18 years or >45 years at enrollment

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary exacerbations	2010-2018	Annual pulmonary exacerbation rate (PEx) (defined as episodes requiring intravenous antibiotic use at home or in hospital)

Secondary Outcome Measures

Name	Time	Method
Serum glucose trends	2010-2018	Incidence of insulin resistance or time to CF-related diabetes requiring insulin treatment
Unintended pregnancy	2010-2018	Absolute number of self-reported unplanned pregnancies. We will also correlate date of reported unplanned pregnancy with dates of taking a CFTR modulator
Pseudomonas aeruginosa	2010-2018	Rate of conversion from non-mucoid to mucoid P. aeruginosa
Nutritional status	2010-2018	BMI trends
Liver dysfunction	2010-2018	Incidence of gallstones requiring surgery, hepatic steatosis, hepatic cirrhosis and/or increased liver enzyme test values (ALT/GGT)
Bone health	2013-2018	DXA scan determination of osteopenia or osteoporosis
Lung function	2010-2018	Absolute change in FEV1 (in liters) measurements over time.
Thromboembolism	2010-2018	Incidence of venous or arterial thromboembolism. Noted on self-respondent survey (defined as blood clot requiring anticoagulation treatment)

Trial Locations

Locations (10)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Boston Children's Hospital/Harvard; 🇺🇸 Boston, Massachusetts, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California - San Diego; 🇺🇸 San Diego, California, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States