CASE4CF: Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

Sponsor

University of Washington (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04568980

Collaborator

(none)

562

Enrollment

Locations

Anticipated Duration (Months)

56.2

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Contraception

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 Design

Study Type:

Observational

Actual Enrollment :

562 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis: A Retrospective Analysis

Actual Study Start Date :

Sep 30, 2020

Actual Primary Completion Date :

May 2, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hormonal contraceptive users Persons exposed to any hormonal method of birth control. This includes combined oral contraceptive pills, combined transdermal patch, combined vaginal ring, progestin-only pills, depo-medroxyacetate, levonorgestrel intrauterine system/device, hormonal subdermal implant
Non-hormonal contraceptive users Persons exposed to any non-hormonal method of birth control. This includes male or female sterilization methods, Copper intrauterine device, internal/external condoms, diaphragm, cervical cap, withdrawal, sponge, fertility based methods, spermicide
Non-contraceptive users Persons who did not use any method of birth control

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Liver dysfunction [2010-2018]
Incidence of gallstones requiring surgery, hepatic steatosis, hepatic cirrhosis and/or increased liver enzyme test values (ALT/GGT)
Serum glucose trends [2010-2018]
Incidence of insulin resistance or time to CF-related diabetes requiring insulin treatment
Nutritional status [2010-2018]
BMI trends
Bone health [2013-2018]
DXA scan determination of osteopenia or osteoporosis
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California - San Diego	San Diego	California	United States	92093
3	National Jewish Health	Denver	Colorado	United States	80206
4	Johns Hopkins University	Baltimore	Maryland	United States	21218
5	Boston Children's Hospital/Harvard	Boston	Massachusetts	United States	02115
6	Mount Sinai Beth Israel	New York	New York	United States	10003
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260
9	University of Texas Southwestern	Dallas	Texas	United States	75390
10	University of Washington	Seattle	Washington	United States	98105