Gynecological Health Improvement of Adult Women With Cystic Fibrosis (IMPACT)

Gynecological Health of Adult Women With Cystic Fibrosis: Positive Impact of the Implementation of an On-site Gynecological Consultation

Following the results of the research team's cross-sectional study conducted in 2014 describing insufficient gynecological care, the research team implemented an on-site gynecological consultation in the adult Cystic Fibrosis (CF) centre in 2015. The study aimed to compare the results of two surveys conducted successively in 2014 and in 2017 on a cohort of women with CF attending the Lyon CF adult referral centre. All the women attending the adult CF center in 2017 were asked to complete the same self-report written questionnaire that was completed in 2014 about their contraceptive choices, gynecological follow-up and cervical screening. Questions concerning gynecological comorbidities were added to the 2017 questionnaire.

This current study aimed to evaluate the impact of the implementation of an on-site gynecological consultation on gynecological health of women with CF, as measured through 3 indicators: the proportion of women with regular gynecological follow-up, cervical screening coverage, and contraceptive coverage. The identification of specific gynecological comorbidities was the other objective of this study.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Self-report written questionnaire

• Study Type: Observational
• Enrollment (Actual): 164

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult women at least 18 years old diagnosed with Cystic Fibrosis

Description

Inclusion Criteria:

• women with cystic fibrosis
• subjects followed by the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult women with Cystic Fibrosis; Cohort of 164 women diagnosed with Cystic Fibrosis (CF) who were patients at the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017 (compared to 155 in 2014). Women attending the CF adult centre in 2017 were asked to complete a written questionnaire.

Other: Self-report written questionnaire; Patient questionnaire filled-out in presence of clinical nurse. Gynecological options and contraceptive choices were recorded. Close-ended questions used ("yes/no"): contraception use; contraceptive pill use; contraceptive implant; intrauterine device; tubal sterilization; mechanical contraception; other type of contraception use; previous term delivery; gynecological follow-up; previous Pap smear. If "Yes" was noted, more details were requested (contraception name, delivery date, gynecological follow-up frequency, last Pap smear date). Other gynecological history and management data not included in the 2014 questionnaire: age at first menstruation, menstrual cycle regularity without hormonal contraception, age at menopause, previous human papilloma virus vaccination, recurrent vulvovaginal candidiasis, urinary incontinence, fertility/infertility data, and infertility treatment with assisted reproductive technologies. Results were compared with those obtained in 2014 (121 women).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women with regular gynecological follow-up	Comparison of the proportion of patients with a regular gynecological follow-up (at least yearly) between 2014 and 2017.	2014 - 2017

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Christine Rousset-Jablonski, MD, Hospices Civils de Lyon, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 69HCL18_0530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No