Cystic FibrosisNCT02847208
Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis (CF). Only few studies have described contraceptive practices in cohorts of CF women. The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon adult centre. 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
- Pill or oral medicine
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Dec 2014
- 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: It was a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.
Who may be able to join
- woman with cystic fibrosis
- followed in the Lyon adult centre in 2014
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis (CF). Only few studies have described contraceptive practices in cohorts of CF women.
The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.
Read more
One hundred and twenty women (100%) answered the questionnaire, among whom two were post-menopausal (46 and 59 years of age), and five were pregnant.
Seventy-four per cent of the women declared they had undergone gynaecological followup (89% of the women with transplantation), and only 55% reported having at least one previous Pap smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic women, it was 61%. Among contraception users; 65% used oral contraception, predominantly combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only contraception. Intrauterine device accounted for 10% of patients using contraception, and tubal ligation only 4%.
This study is limited by its cross-sectional design. Despite an internal validation of the questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken into account.
This study of practices highlights the importance of improved information regarding sexuality, fertility and reproductive health in young women with CF. A regular gynaecological follow-up and cervical screening is mandatory in this population.
Better gynaecological care and contraceptive advice would help to avoid unplanned pregnancies, and optimize contraceptive selection in relationship to specific clinical conditions.
- Conditions
- Cystic Fibrosis
- Being tested
- self-report written questionnaire
- Keywords
- cystic fibrosis, contraception, gynaecological follow-up, screening, Pap smear, counselling
- 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
The questionnaire was filled-in by the patients in presence of a clinical nurse. The gynaecological healthcare options and contraceptive choices were recorded. All following questions were closed-ended (answer yes/no): use of contraception; use of contraceptive pill; use of contraceptive implant; use of intrauterine device; use of tubal sterilization; use of mechanical contraception; use of other type of contraception; previous delivery (term pregnancy); gynaecological follow-up; previous Pap smear. In case of a positive answer to one of these questions, more details were requested (depending on the situation: name of the contraception, date of delivery, frequency of the gynaecological follow-up, date of the last pap smear). An internal validation of the questionnaire was performed on a subgroup of patients.
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis women | It was a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry. 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 patients with a regular gynecological follow-up and cervical screening
Measured: At completion of the questionnaire (Day 1)
Secondary outcomes (1)
Proportion of women using contraception and contraceptive type
Measured: At completion of the questionnaire (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- 155 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, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847208
- Sponsor's protocol ID
- 69HCL16_0489
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02847208
- Acronym / sponsor ID
- 69HCL16_0489
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, contraception, gynaecological follow-up, screening, Pap smear, counselling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis (CF). Only few studies have described contraceptive practices in cohorts of CF women.
The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.
One hundred and twenty women (100%) answered the questionnaire, among whom two were post-menopausal (46 and 59 years of age), and five were pregnant.
Seventy-four per cent of the women declared they had undergone gynaecological followup (89% of the women with transplantation), and only 55% reported having at least one previous Pap smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic women, it was 61%. Among contraception users; 65% used oral contraception, predominantly combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only contraception. Intrauterine device accounted for 10% of patients using contraception, and tubal ligation only 4%.
This study is limited by its cross-sectional design. Despite an internal validation of the questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken into account.
This study of practices highlights the importance of improved information regarding sexuality, fertility and reproductive health in young women with CF. A regular gynaecological follow-up and cervical screening is mandatory in this population.
Better gynaecological care and contraceptive advice would help to avoid unplanned pregnancies, and optimize contraceptive selection in relationship to specific clinical conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis women | – | Other: self-report written questionnaireIt was a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It was a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.
Key inclusion criteria (2 listed)
- woman with cystic fibrosis
- followed in the Lyon adult centre in 2014
Key exclusion criteria (1 listed)
- No exclusion criteria
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 questionnaireThe questionnaire was filled-in by the patients in presence of a clinical nurse. The gynaecological healthcare options and contraceptive choices were recorded. All following questions were closed-ended (answer yes/no): use of contraception; use of contraceptive pill; use of contraceptive implant; use of intrauterine device; use of tubal sterilization; use of mechanical contraception; use of other type of contraception; previous delivery (term pregnancy); gynaecological follow-up; previous Pap smear. In case of a positive answer to one of these questions, more details were requested (depending on the situation: name of the contraception, date of delivery, frequency of the gynaecological follow-up, date of the last pap smear). An internal validation of the questionnaire was performed on a subgroup of patients. | Other | cystic fibrosis women |
Primary outcome
Proportion of patients with a regular gynecological follow-up and cervical screening
Time frame: At completion of the questionnaire (Day 1)
1 secondary outcome
Proportion of women using contraception and contraceptive type
Time frame: At completion of the questionnaire (Day 1)
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 28 Jul 2016.
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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
Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 patients with a regular gynecological follow-up and cervical screening (time frame: At completion of the questionnaire (Day 1)). 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 28 Jul 2016.