Cystic FibrosisIMPACTNCT03892304
Gynecological Health Improvement of Adult Women With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Self-report written questionnaire
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women at least 18 years old diagnosed with Cystic Fibrosis
Who may be able to join
- women with cystic fibrosis
- subjects followed by the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017
Who cannot join
- None
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Self-report written questionnaire
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report written questionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-report written questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2014 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Rousset-Jablonski, MD, Principal investigator, Hospices Civils de Lyon, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892304
- Sponsor's protocol ID
- 69HCL18_0530
- Acronym
- IMPACT
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecological Health of Adult Women With Cystic Fibrosis: Positive Impact of the Implementation of an On-site Gynecological Consultation
- ClinicalTrials.gov ID
- NCT03892304
- Acronym / sponsor ID
- IMPACT / 69HCL18_0530
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult women with Cystic Fibrosis | – | Other: Self-report written questionnaireCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women at least 18 years old diagnosed with Cystic Fibrosis
Key inclusion criteria (2 listed)
- women with cystic fibrosis
- subjects followed by the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-report written questionnairePatient 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). | Other | Adult women with Cystic Fibrosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Rousset-Jablonski, MD principal investigator
Hospices Civils de Lyon, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with regular gynecological follow-up (time frame: 2014 - 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.