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Doi:10.1016/j.contraception.2004.02.006

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system bReproductive Health Consultant, Vesancy, France Received 5 January 2003; received in revised form 3 February 2004; accepted 16 February 2004 Abstract
Objective: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix௡ 200 small) and a
copper-levonorgestrel (GynePlant™) intrauterine system (IUS) on the amount of menstrual blood loss (MBL).
Methods: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique.
Results: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant
users, mean MBL scores decreased by at least 50% in all but one user.
Conclusion: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL,
without causing amenorrhea, can be obtained by adding levonorgestrel. 2004 Elsevier Inc. All rights reserved.
Keywords: GyneFix copper contraceptive; Anchored IUS; Frameless IUD; GynePlant 1. Introduction
IUD As the increase in MBL in IUD users is propor-tional to the size of the IUD, it seemed logical to experiment The standard GyneFix௡ with effective copper surface with copper IUD models that have no plastic frame to limit area of 330 mm2 is a highly effective intrauterine contra- the size of the foreign body. The present study reports on the ceptive device (IUD). Cumulative failure rates range from MBL observed during use of the small GyneFix 200 IUD, 0.0/100 users to 2.5/100 users up to 10 years of use (data compared with before use. Previous studies demonstrated from published and unpublished randomized and nonran- the high efficacy of the small frameless IUD in a 3-year domized comparative clinical trials) The high efficacy of the GyneFix IUD is attributed to the fact that the frame- Furthermore, the knowledge that intrauterine progestin- less device is anchored to the fundus of the uterus, elimi- release drastically reduces MBL prompted the authors to nating downward displacement, which increases the failure assess the effect of a combined copper-levonorgestrel-re- rate, and because the total surface area of the copper sleeves (inner and outer surfaces) is available for release of copperions.
An important drawback of IUDs is their tendency to 2. Materials and methods
cause heavy, sometimes painful, menstrual bleeding. Heavybleeding is the most common cause for IUD discontinua- The use of the study products was approved by the tion. The GyneFix standard also increases menstrual blood loss (MBL), although to a lesser degree than the TCu380A 2.1. Description of the IUD and IUS The two intrauterine devices are described briefly below * Corresponding author, present affiliation. Piers de Raveschootlaan (see They use the same anchoring system as de- 125, 8300 Knokke, Belgium. Tel.: ϩ32-50-600900; fax: ϩ32-50-622429.
E-mail address: dirk.wildemeersch@contrel.be (D. Wildemeersch).
0010-7824/04/$ – see front matter 2004 Elsevier Inc. All rights reserved.
doi:10.1016/j.contraception.2004.02.006 D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172 Fig. 1. GyneFix௡ 200 (small) (left), GynePlant™ (right).
The GyneFix 200 (small) IUD consists of four copper sleeves only, with total length of 2 cm, and with total The statistical significance in the studies using the visual surface area of copper, including the inner and outer sur- assessment technique was calculated according to the Wil- coxon signed-rank test, p Ͻ 0.05 denoting significance.
The GynePlant IUS consists of the same number of 3. Results
copper sleeves as the GyneFix 200 IUD. Attached to thelower copper tube extends a fibrous delivery system of 1.2 mm in diameter and 1.5 cm in length deliveringapproximately 5 ␮g of levonorgestrel (LNG) per day for MBL was assessed in 60 Belgian parous (n ϭ 23) and nulliparous women (n ϭ 37) using the visual assessmentscoring technique as described. The trial covers a periodfrom a minimum of 9 months to more than 3 years. Women 2.2. Assessment of MBL using the visual assessment subjectively reported similar menstruation patterns with the GyneFix 200 IUD when compared with MBL before inser-tion. This corresponds closely with the menstrual scores Women with normal and with heavy menstrual periods The median bleeding score before treatment was were admitted in the study. A visual assessment tech- 110.5 (range, 28 –265) and 110 (range, 28 –260) after 3–51 nique was used as described by Janssen et al. Infor- months follow-up, which is not statistically different (p ϭ mation on menstrual bleeding was obtained by interview prior to entering the study using a pictorial chart form todescribe the degree to which the sanitary wear wassoiled. A score was calculated by multiplying the numberof slightly, moderately and heavily soiled pads and tam-pons by 1, 5 and 20 for pads and 1, 5 and 10 for tampons,respectively, according to their degree of staining The visual assessment technique does not yield anexact flow in milliliters but, in practice, the sensitivityand specificity is reasonably high and superior to a wom-an’s subjective assessment of MBL. For purposes ofevaluating the effect of treatment, the visual assessmenttechnique is highly practical compared with the quanti-tative method as women no longer have to carry used Fig. 2. The pictorial chart form. The numbers 1– 8 represent the consecu- D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172 however, does not affect MBL. Milson et al. showed that Characteristics of the study groupa and analysis of the visual menstrual women using MLCu250 do not have reduced MBL compared bleeding scores (MS) before and after use of the GyneFix® 200 IUD to women wearing a high-load MLCu375 IUD Further reduction of MBL can be achieved by adding a hormone- releasing system. Levonorgestrel has been extensively studied in this respect. The advantage of GynePlant is that the efficacy of the device is not dependent on the LNG release as its 200 mm2 of copper surface area exposed to the uterine environ- ment provides high contraceptive protection similar to the high copper-load conventional IUDs, which have a much lower Wilcoxon matched-pair signed-rank test: p ϭ 0.596 (NS).
proportion of exposed copper surface area a N ϭ 60, parous n ϭ 23, nulliparous n ϭ 37.
A considerable reduction in MBL was seen in all but one woman treated with the “low-dose” (5 ␮g/d) GynePlant copper-releasing IUS. The development of the framelessdevice is a response to the growing need to develop high- MBL was assessed in 21 Belgian parous (n ϭ 7) and performing, long-acting, reversible and acceptable contra- nulliparous women (n ϭ 14) using the visual assessment ceptives with a high continuation of use. The GynePlant is scoring technique. The trial period ranged from 8 months to a further development that may offer additional advantages, more than 2 years. All women reported reduced bleeding particularly with respect to reduced bleeding. This device except one. In the latter, menstrual bleeding remained the could be useful in women with heavy menstruation and who same as before. No cases of amenorrhea (absence of men- do not accept the amenorrhea associated in many cases with strual bleeding during a period of 3 months) resulting from the levonorgestrel intrauterine system. Another advantage endometrial suppression were encountered The of the GynePlant is that the contraceptive efficacy should be mean bleeding score before treatment was 222.6 (range, maintained after the drug reservoir is exhausted.
40 –530) and dropped to a mean score of 64.4 (range,5–150) after 8 –28 months follow-up, which is highly sta-tistically significant (p Ͻ 0.001).
5. Conclusion
The impact on MBL with copper IUDs can be minimized 4. Discussion
by reducing the surface area of the foreign body. Reduction ofMBL, without causing amenorrhea, can be obtained by adding This article evaluated ways to minimize the effect on levonorgestrel. The small frameless GyneFix IUD minimizes MBL and to reduce the amount of menstrual bleeding with the impact on MBL. It would appear likely that the contracep- copper-releasing IUDs. Although the mechanism by which tive efficacy of the GynePlant will even be enhanced due to the this occurs is complex, the remedy seems to be simple. The effect of the added potent contraceptive hormone.
present studies suggest that by significantly reducing thesurface area of the foreign body, the impact on the amountof menstrual bleeding will be minimized. A previous MBL Acknowledgments
study found that the frameless copper-releasing IUD hasless impact on MBL than the larger TCu380A IUD The The authors greatly acknowledge Prof. Dr. G. Van frameless IUD may also reduce prolonged or intermenstrual Maele, Dr. Sc., of the Department of Medical Informatics bleeding due to the absence of a frame, eliminating the risk and Statistics, University Hospital Ghent, Belgium, for pro- of endometrial trauma. Reducing the copper surface area, viding statistical data analysis for the study. Dirk Wilde-meersch is a Belgian gynecologist and Medical Director ofContrel Research, a company that was established to man- age clinical research and to develop and study innovative Visual menstrual bleeding scores (MS) before and during treatment drug delivery technologies (www.contrel.be). Contrel is the (observation from 8 months to 24 months) in 21 GynePlant™ users manufacturer of GyneFix and GynePlant.
References
[1] Wildemeersch D, Bata´r I, Affandi B, et al. The ‘frameless’ intrauterine system for long-term, reversible contraception: a review of 15 years of clinical experience. J Obstet Gynaecol Res 2003;290:160 –9.
Wilcoxon matched-pair signed-rank test: p Ͻ 0.001 (highly significant).
[2] Andrade ATL, Souza JP, Andrade GN, Rowe PJ, Wildemeersch D.
D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172 Assessment of menstrual blood loss in Brazilian users of the frameless [5] Janssen CA, Scholten PC, Heintz APM. A simple visual assessment copper-releasing IUD with copper surface area of 330 mm2 and users technique to discriminate between menorrhagia and normal menstrual of the levonorgestrel-releasing intrauterine system. Contraception blood loss. Obstet Gynecol 1995;85:977– 82.
[6] Milson I, Rybo G, Lindstedt G. The influence of copper surface area on [3] Cao X, Zhang W, Zhao X, et al. Three-year efficacy and acceptability menstrual blood loss and iron stores in women fitted with an IUD.
of the GyneFix® 200 intrauterine system (IUS). Contraception 2004; [7] Wildemeersch D, Dhont M, Temmerman M, et al. GyneFix®-LNG: [4] Wu S, Hu J, Wildemeersch D. Performance of the Frameless GyneFix preliminary clinical experience with a copper and levonorgestrel re- and the TCu380A IUDs in a three-year multicenter randomized com- leasing intrauterine system. European J Contracept Reprod Health Care parative trial in parous women. Contraception 2000;61:91–9.

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