Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis

NCT ID: NCT04568980

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 562 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-12-06

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.

Conditions

Cystic Fibrosis; Contraception

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Non-contraceptive users

Persons who did not use any method of birth control

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Emily Godfrey

Associate Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily M Godfrey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California - San Diego

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital/Harvard

Boston, Massachusetts, United States

Mount Sinai Beth Israel

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00008095

Identifier Type: -

Identifier Source: org_study_id