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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03892304
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Other: Self-report written questionnaire

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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gynecological Health of Adult Women With Cystic Fibrosis: Positive Impact of the Implementation of an On-site Gynecological Consultation
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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).

Primary Outcome Measures :
  1. Proportion of women with regular gynecological follow-up [ Time Frame: 2014 - 2017 ]
    Comparison of the proportion of patients with a regular gynecological follow-up (at least yearly) between 2014 and 2017.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult women with Cystic Fibrosis
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult women at least 18 years old diagnosed with Cystic Fibrosis

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03892304

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

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03892304     History of Changes
Other Study ID Numbers: 69HCL18_0530
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases