The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial

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. STUDY DESIGN: Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitte...

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Main Authors:	Meirik, O., Rowe, P. J., Peregoudov, A., Piaggio, G., Petzold, M.
Format:	Journal Article
Language:	EN
Published:	2012
Subjects:	Adolescent Adult Equipment Design Female Follow-Up Studies Humans Copper Intrauterine Devices Metrorrhagia Pelvic Inflammatory Disease Pregnancy Ectopic Pregnancy Unwanted Pregnancy Young Adult
Online Access:	http://hdl.handle.net/10986/5108

id	okr-10986-5108
recordtype	oai_dc
spelling	okr-10986-51082021-04-23T14:02:21Z The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial Meirik, O. Rowe, P. J. Peregoudov, A. Piaggio, G. Petzold, M. Adolescent Adult Equipment Design Female Follow-Up Studies Humans Copper Intrauterine Devices Metrorrhagia Pelvic Inflammatory Disease Pregnancy Ectopic Pregnancy Unwanted Pregnancy Young Adult 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. STUDY DESIGN: 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. 2012-03-30T07:31:19Z 2012-03-30T07:31:19Z 2009 Journal Article Contraception 1879-0518 (Electronic) 0010-7824 (Linking) http://hdl.handle.net/10986/5108 EN http://creativecommons.org/licenses/by-nc-nd/3.0/igo World Bank Journal Article
repository_type	Digital Repository
institution_category	Foreign Institution
institution	Digital Repositories
building	World Bank Open Knowledge Repository
collection	World Bank
language	EN
topic	Adolescent Adult Equipment Design Female Follow-Up Studies Humans Copper Intrauterine Devices Metrorrhagia Pelvic Inflammatory Disease Pregnancy Ectopic Pregnancy Unwanted Pregnancy Young Adult
spellingShingle	Adolescent Adult Equipment Design Female Follow-Up Studies Humans Copper Intrauterine Devices Metrorrhagia Pelvic Inflammatory Disease Pregnancy Ectopic Pregnancy Unwanted Pregnancy Young Adult Meirik, O. Rowe, P. J. Peregoudov, A. Piaggio, G. Petzold, M. The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
relation	http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description	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. STUDY DESIGN: 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.
format	Journal Article
author	Meirik, O. Rowe, P. J. Peregoudov, A. Piaggio, G. Petzold, M.
author_facet	Meirik, O. Rowe, P. J. Peregoudov, A. Piaggio, G. Petzold, M.
author_sort	Meirik, O.
title	The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
title_short	The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
title_full	The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
title_fullStr	The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
title_full_unstemmed	The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
title_sort	frameless copper iud (gynefix) and the tcu380a iud : results of an 8-year multicenter randomized comparative trial
publishDate	2012
url	http://hdl.handle.net/10986/5108
_version_	1764393975310974976

The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial

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