The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial.
Contraception
; 80(2): 133-41, 2009 Aug.
Article
en En
| MEDLINE
| ID: mdl-19631788
ABSTRACT
BACKGROUND:
Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared. STUDYDESIGN:
Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years.RESULTS:
Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI 4.4-6.4) per 100 and 2.5 (95% CI 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI 0.9-2.0) and 0.5 (95% CI 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI 0.7-1.9) and 2.5 (95% CI 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different.CONCLUSIONS:
The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Embarazo no Deseado
/
Dispositivos Intrauterinos de Cobre
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
Límite:
Adolescent
/
Adult
/
Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
Contraception
Año:
2009
Tipo del documento:
Article
País de afiliación:
Suiza