Orientador: Ilza Maria Urbano Monteiro / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas / Made available in DSpace on 2018-08-19T23:33:10Z (GMT). No. of bitstreams: 1 Makuch_MariaValeriaBahamondes_D.pdf: 16535785 bytes, checksum: be3709b6137735be64ac9a6dfffdc1a5 (MD5) Previous issue date: 2012 / Resumo: Introdução: O sistema intrauterino liberador de levonorgestrel (SIU-LNG) é um contraceptivo altamente efetivo com benefícios não contraceptivos, entre eles o tratamento da menorragia. Restam dúvidas sobre o uso do SIU-LNG em mulheres nuligestas, especialmente no tocante à taxa de expulsão e o custo-beneficio para o tratamento da menorragia quando se compara com tratamentos cirúrgicos. Os objetivos deste estudo foram avaliar a facilidade de inserção e o desempenho clínico do SIU-LNG em mulheres nuligestas durante um ano de seguimento; verificar a correlação entre o comprimento da cavidade uterina e as taxas de expulsão em usuárias de dispositivo intrauterino com cobre (DIU TCu380A) e de SIU-LNG, e avaliar os recursos e procedimentos envolvidos na inserção do SIU-LNG quando comparado à realização da histerectomia em mulheres com menorragia atendidas em um hospital público do Brasil. Métodos: Foi feito o seguimento de duas coortes de mulheres que inseriram o SIU-LNG no mesmo dia, 159 nuligestas e 477 mulheres com filhos, pareadas na razão1:3. A inserção foi classificada em fácil ou difícil, e quando foi difícil avaliou-se o uso de velas de Hegar ou misoprostol, e as falhas de inserção foram registradas separadamente. O segundo estudo admitiu 235 mulheres nuligestas e mulheres com filhos que inseriram o DIU TCu380A ou o SIU-LNG, com o seguimento de um ano. O comprimento da cavidade uterina foi medido por histerometria e por ultrassom, e a taxa de expulsão foi correlacionada com o tamanho uterino. O terceiro estudo teve duas coortes de mulheres com menorragia, mulheres que inseriram o SIU-LNG (n=124) pareadas com mulheres que realizaram uma histerectomia (n=122). Avaliamos o número de procedimentos realizados em cada grupo antes de escolherem o tratamento, os que foram realizados para a inserção do SIU-LNG e/ou histerectomia, e os procedimentos decorrentes das complicações registradas após um ano de seguimento. Resultados: Em quase 80% dos casos não foi encontrada dificuldade na inserção do SIU-LNG e o uso de dilatadores e misoprostol não foi frequente; entretanto, o uso de dilatadores foi três vezes maior no grupo das nuligestas. Houve uma falha da inserção no grupo de nuligestas e duas no grupo de mulheres com filhos. Não houve uma única gravidez, a taxa de expulsão foi de aproximadamente 4/100 mulheres/ano e a taxa de continuação do método foi superior a 90%, em ambos os grupos, após um ano de seguimento. A medida do comprimento da cavidade uterina foi menor que 3,2cm em 2 usuárias e de pelo menos 3,2cm de comprimento em 87 usuárias de SIU-LNG, com taxas de expulsão de 0 (0,0%) e 2 (2,3%), respectivamente (p>0,999). A média de comprimento da cavidade uterina foi de 3,9cm ± 0,3cm por ultrassom entre as 10 mulheres que expulsaram o dispositivo, comparada com a média de comprimento de 3,9 ± 0,0cm naquelas que não expulsaram o dispositivo (p=0,799). No terceiro estudo, a idade e duração da menorragia foram significativamente menores no grupo de usuárias de SIU-LNG do que no grupo de mulheres que realizaram histerectomia. Os números de consultas ginecológicas e de coleta de citologia oncológica foram levemente maiores no grupo do SIU-LNG, mas as mulheres que realizaram histerectomia realizaram testes mais complexos, como exames de laboratório, ultrassom, radiografia de tórax e eletrocardiograma. No grupo da histerectomia as principais complicações foram: hemorragia (6), perfuração de bexiga/intestino (4), complicações anestésicas (1), reimplantação ureteral (1) e dor abdominal (2). Aos 12 meses de seguimento, a menorragia foi controlada em 83,1% das mulheres no grupo do SIU-LNG e 106 mulheres continuaram usando o dispositivo. Conclusões: O SIU-LNG mostrou-se um método seguro para uso em mulheres nuligestas. A inserção é um procedimento simples e o desempenho clínico foi bom em mulheres com e sem filhos. O comprimento da cavidade uterina não foi associado a maior risco de expulsão do SIU-LNG. Ambos os tratamentos, SIU-LNG e histerectomia, foram efetivos para controlar a menorragia. O grupo de usuárias de SIU-LNG usou menos recursos e teve menos complicações que o grupo da histerectomia. O SIU-LNG mostrou-se um bom método para reduzir o número de histerectomias e de recursos usados no tratamento de mulheres com menorragia / Abstract: Background: Despite the high contraceptive efficacy and the additional non-contraceptive benefits such as treatment of heavy menstrual bleeding (HMB) of the levonorgestrel-releasing intrauterine system (LNG-IUS), concerns persist with respect to its use in nulligravidas, the expulsion rate in this group and the cost-effectiveness when compare to surgical treatments in the treatment of HMB. The objectives of this study were to evaluate the ease of insertion and clinical performance of the LNG-IUS in nulligravida women up to one year after insertion; the correlation between endometrial cavity length and expulsion rate in acceptors of the TCu380A intrauterine device (IUD) or LNG-IUS; and to evaluate the resources and procedures involved in the placement of an LNG-IUS compared to performing hysterectomy in women with HMB in a public sector hospital in Brazil. Methods: Two cohorts were formed following LNG-IUS insertion, one consisting of 159 nulligravidas and the other of 477 parous women. Each nulligravida women was paired with 3 parous women who had an LNG-IUS inserted on the same day. Insertion was classified as easy or difficult and when classified as difficult, the use of Hegar dilators and/or misoprostol, and insertion failure were also recorded. The second study included 235 nulligravida and parous women who received a TCu380A IUD or LNG-IUS and who were followed up to 1 year. The length of the uterine cavity was measured by uterine sounding and ultrasonography, and the expulsion rate was correlated to uterine size. The third study had two cohorts of women: women who accepted an LNG-IUS (n=124) and a matched woman who underwent hysterectomy on the same day (n=122), due to HMB. We evaluate the number of procedures carried out in each group of women, including those performed before the decision was made to insert an LNG-IUS or to perform hysterectomy, the insertion of the device itself and the surgical procedure and the procedures and complications registered up to one year after LNG-IUS insertion or hysterectomy. Results: In almost 80% of cases, no difficulty was encountered during insertion, and dilators and misoprostol were seldom required; however, when necessary, dilator use was almost three-fold higher in nulligravida women. Insertion failed in one nulligravida women and in two parous women. The clinical performance of the device showed zero pregnancy rate, expulsion rates of ~4/100 women/year and one-year continuation rate of over 90% in both groups. When we measured the endometrial cavity, we showed that it was shorter than 3.2 cm in 2 LNG-IUS users and at least 3.2 cm long in 87 LNG-IUS users, with expulsions occurring in 0 (0.0%) and 2 (2.3%) of these women, respectively (p>0.999). The mean length of the endometrial cavity evaluated by ultrasonography among the 10 women whose devices were expelled was 3.9 ± 0.3 cm, compared with 3.9 ± 0.0 cm in those who retained their devices (P=0.799). On the third study, age and the duration of HMB were significantly lower in the LNG-IUS acceptors than women at the hysterectomy group. The number of gynecological consultations and Pap smears were similar in both groups; however, women in the hysterectomy group also underwent laboratory tests, ultrasonography, chest X-ray and electrocardiogram. In the hysterectomy group, the main complications were: hemorrhage (6), bladder/bowel perforation (4), complications with anesthesia (1), ureteral reimplantation required (1) and abdominal pain (2). At one year, HMB was controlled in 83.1% of women in the LNG-IUS group and 106 women continued with the device. Conclusions: The LNG-IUS was suitable for use by nulligravidas. It is simple to insert and its clinical performance in nulligravidas was similar to that found in parous women. The length of the endometrial cavity do not support the hypothesis of an association between uterine length and risk of LNG-IUS expulsion. Both treatments were effective in HMB control. Fewer resources and complications were observed in LNG-IUS acceptors when compared to hysterectomy. The LNG-IUS represents a good strategy for reducing the number of hysterectomies and the resources required for women with HMB / Doutorado / Fisiopatologia Ginecológica / Doutor em Ciências da Saúde

OBJECTIVE: The objective of this study was to evaluate outcomes for women following endometrial ablations due to abnormal uterine bleeding (AUB). These outcomes included patient-reported quality of life, satisfaction with the procedure, and treatment failure. Women experiencing heavy/regular bleeding were compared with women experiencing heavy/irregular bleeding. DESIGN: The study was designed as a prospective cohort study of women aged 18-55 years presenting to Women and Infants Hospital (WIH) in Providence, Rhode Island, for endometrial ablations due to AUB. Sixty-three participants in the study completed the Baseline Health Form, the Short Form-36 Health Survey (SF-36), and the Menstrual Bleeding Questionnaire (MBQ) upon enrollment. At the 3-month, 6-month, and 1-year follow-ups participants completed the SF-36 and the MBQ. RESULTS: Baseline responses from the participants who were undergoing endometrial ablation found that 95.2% of women (n = 60) identified their periods as being heavy. From the total participants, 60.3% of women (n = 38) indicated their periods as being irregular. The SF-36 total score results demonstrate women with heavy/irregular bleeding experienced a greater negative impact in their quality of life. When broken down to the physical component score (PCS) and the mental component score (MCS) this difference, between women with heavy/regular bleeding and women with heavy/irregular bleeding, was minimized. Results from the MBQ revealed that women with heavy/irregular menstrual bleeding experienced a greater negative impact on their quality of life compared with women with heavy/regular bleeding. DISCUSSION: Heavy bleeding is one of the defining factors in determining whether women seek further treatment for their menstrual bleeding, and when they do, they will usually attempt other therapies before pursuing surgery. The MBQ revealed a difference in quality of life between women with heavy/irregular bleeding and women with heavy/regular bleeding because this questionnaire measures bleeding and its impact on a woman’s life. The SF-36 total scores also showed a difference between heavy/irregular bleeding and heavy/regular bleeding. Breaking down the total SF-36 total score into the PCS and MCS minimized this difference. This questionnaire focused more on overall general health rather than bleeding and this focus may account for the smaller scoring differences among bleeding patterns. CONCLUSION: Similar proportions of women experiencing heavy/regular and heavy/irregular bleeding pursue endometrial ablations as a treatment for AUB. The SF-36 demonstrated a greater burden on women’s general health when they have heavy/irregular bleeding. The MBQ provides a better measure to compare both bleeding patterns, aspects of bleeding, and demonstrates a more negative impact on quality of life for women with heavy/irregular bleeding.