- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02847208
Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Pierre-Benite, Frankrig, 69495
- Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- woman with cystic fibrosis
- followed in the Lyon adult centre in 2014
Exclusion Criteria:
- No exclusion criteria
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of patients with a regular gynecological follow-up and cervical screening
Tidsramme: At completion of the questionnaire (Day 1)
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At completion of the questionnaire (Day 1)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of women using contraception and contraceptive type
Tidsramme: At completion of the questionnaire (Day 1)
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At completion of the questionnaire (Day 1)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christine Rousset Jablonski, MD, Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69HCL16_0489
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Kliniske forsøg med Cystisk fibrose
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M.D. Anderson Cancer CenterRekrutteringFibrose | Lymfødem | Fibrosis syndrom | Hoved & amp; HalskræftForenede Stater
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National Cancer Centre, SingaporeMerck Sharp & Dohme LLC; National Cancer Center, JapanIkke rekrutterer endnuTilbagevendende adenoid cystisk karcinom | Papillært skjoldbruskkirtelcarcinom | Adenoid Cystic Carcinoma MetastatiskSingapore, Japan, Malaysia, Sydkorea
Kliniske forsøg med self-report written questionnaire
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Dr. Behcet Uz Children's HospitalAfsluttet
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Jena University HospitalRekrutteringIntrauterin vækstrestriktion | Pentaerithrityl-teratnitrat under graviditet | Langtidsvirkninger på børnTyskland