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Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02847208
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


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

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Study Type : Observational
Actual Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: self-report written questionnaire
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.




Primary Outcome Measures :
  1. Proportion of patients with a regular gynecological follow-up and cervical screening [ Time Frame: At completion of the questionnaire (Day 1) ]

Secondary Outcome Measures :
  1. Proportion of women using contraception and contraceptive type [ Time Frame: At completion of the questionnaire (Day 1) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • woman with cystic fibrosis
  • followed in the Lyon adult centre in 2014

Exclusion Criteria:

- No exclusion criteria


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 ClinicalTrials.gov identifier (NCT number): NCT02847208


Locations
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France
Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Benite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Christine Rousset Jablonski, MD Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02847208     History of Changes
Other Study ID Numbers: 69HCL16_0489
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
cystic fibrosis
contraception
gynaecological follow-up
screening
Pap smear
counselling
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs