Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847208
• Other study ID #: 69HCL16_0489
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• woman with cystic fibrosis

• followed in the Lyon adult centre in 2014

Exclusion Criteria:

• No exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
France	Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a regular gynecological follow-up and cervical screening		At completion of the questionnaire (Day 1)	No
Secondary	Proportion of women using contraception and contraceptive type		At completion of the questionnaire (Day 1)	No