- Email: [email protected]
M122 LIPID PROFILE OF WOMEN ON EXTENDED REGIMENS OF COMBINED ORAL CONTRACEPTIVES: DO DIFFERENT TYPES OF PROGESTOGENS MAKE A DIFFERENCE?
Poster presentations / International Journal of Gynecology & Obstetrics 119S3 (2012) S531–S867
implanon inserted between 4 to 10 weeks of pospartum and were follow-up after 3 months and six months after the insertion. Results: There were 33 women enrolled in the study. Mean age of the patients was 30 years (range 24–41 years). Of those, 17 patients delivered by caesarean section while 16 patients had vaginal delivery. During first visit, 57.6% had amenorrhoea, 21.2% had prolonged bleeding while the incidence of normal, and irregular bleeding were 15.1% and 6.1% respectively. In second visit, 63.6% had amenorrhoea, 6.1% had prolonged bleeding while the incidence of normal and irregular bleeding were 21.2% and 9.1% respectively. Only two patients seek medical treatment due to prolonged bleeding. 28 patients continue to breast fed their babies while 5 patients stopped breast feeding while on implanon. The majority of women expressed satisfaction to her implano® use, only three patients were not satisfied mainly due to side-effects of prolonged or irregular bleeding. There was no removal after six months follow-up. Conclusions: Implano® is a good, well accepted long-term contraceptive method for post partum women and lactating mothers. Dissatisfaction of its use is mainly due to abnormal menstrual bleeding pattern. M122 LIPID PROFILE OF WOMEN ON EXTENDED REGIMENS OF COMBINED ORAL CONTRACEPTIVES: DO DIFFERENT TYPES OF PROGESTOGENS MAKE A DIFFERENCE? C.A. Guazzelli1 , F. Barreiros2 , R. Barbosa3 , M.R. Torloni1 , M. Barbieri1 , F. Assis2 , F.F. Araujo1 . 1 S˜ ao Paulo Federal University, S˜ ao Paulo, S˜ ao Paulo, Brazil; 2 Oeste Paulista University, Presidente Prudente, S˜ ao Paulo, Brazil; 3 School of Nursing, S˜ ao Paulo University, S˜ ao Paulo, S˜ ao Paulo, Brazil Objectives: The effects of extended regimens of combined oral contraception on clinical symptoms have been extensively studied but there are comparatively few studies on their metabolic effects. We aimed to assess and compare the lipid profile of women on extended regimens of combined oral contraceptives containing two different types of progestogens. Materials: This study enrolled 150 adult women (18–40 years) managed in 2011 at the same gynecology clinic of Oeste Paulista Universtity. Methods: Participants were randomized to take daily pills containing 30 mcg ethinylestradiol and either 75 mcg gestodene (Gr 1) or 150 mcg desonogestrel (Gr 2), continuously for 84 consecutive days followed by a 7 days pill-free interval, during 6 months. Exclusion criteria followed the WHO recommendations. Blood was collected at baseline and at three months intervals to assess total cholesterol, HDL-C, LDL-C, and triglycerides. The ANOVA test was used to compare results of these exams over time. Results: Patient characteristics did not differ between the two groups and the number of dropouts was similar (16% and 12%). There were no pregnancies during the study period. Total cholesterol, LDL-C, HDL-C and triglycerides levels increased slightly hroughout the study period in both groups, but did not differ significantly between the groups. Conclusions: Women on extended regimens of combined oral contraceptives for 6 months have similar changes in their lipid profile regardless of the type of progestagen used. M123 DIABETES MELLITUS AND CONTRACEPTION O. Tanko1 , M.V. Samoylova2 , G. Maltsev1 , E. Blagoveschenskiy1 . 1 Obstetrics and Gynecology #2, Kharkiv National Medical University, Kharkiv, Ukraine; 2 National O.O. Bohomolets Medical University, Kyiv, Ukraine Objectives: In recent ages in the world the steady growth of illness with diabetes mellitus becomes perceptible. Pregnancy with diabetes mellitus is accompanied by the high complications
S571
number, increasing perinatal death rate. That is why prevention of unwanted pregnancy, planning of possible pregnancy in the illness compensation phase are the important questions of contemporary reproductology. The aim of the research was a dynamic observation of hemostasis parameters in patients with diabetes mellitus type I on the basis of oral contraceptives (OC) containing estradiol valerate (E2V)/dienogest (DNG) taking. Materials: Patients with diabetes mellitus type I in the age up to 35 years were observed. Besides patients with high body mass index (BMI), hypertension, diabetes retinopathy, nephropathy and other vascular complications were excluded. Methods: For hemostasis system learning functional activity of thrombocytes, coagulative potential of blood and level of endothelin-1 were studied. Results: During estimation of hemostasis system on the basis of three months OC containing E2V/DNG taking in 12.5% of women with diabetes mellitus type I we noted extension of adenosindiphosphoric (ADP)-induced thrombocytes aggregation (p < 0.05), in 9.4% of women we observed some gain in coagulative potential of blood with Activated Partial thromboplastin time (APTT) shortening, increasing of fibrinogen concentration (p < 0.01). Tendency to endotheling-1 level extension was noted in 15.6% of women. However we didn’t find any thrombophylic complications on this stage among observed women. Described hemostasis system profile changed on the ninth month of OC containing E2V/DNG taking. During this period in observed women thrombocytes aggregation intensiveness lowering was noted. Changes in plasmatic factors of hemostasis were characterized by the APTT prolongation, lowering of fibrinogen level up to the physiologic values. Endothelin-1 level was higher comparing to the control only in two patients. Hence while prolonging time of OC containing E2V/DNG taking to the nine months we noted gradual restoration of coagulative blood system markers, rheologic blood features improvement, endothelial dysfunction elimination. Conclusions: Patients with non-complicated diabetes mellitus type I demonstrated favorable OC containing E2V/DNG acceptability profile while using it for contraceptive purposes. M124 WOMEN’S EXPECTATIONS AND SATISFACTION ON BLEEDING PATTERN WHEN USING IMPLANON NXT F. Beligotti1 , E. Mommers1 , M. Marintcheva-Petrova1 . 1 Merck Sharp & Dohme, Oss, Netherlands Objectives: To assess women’s expected and actual bleeding pattern and the impact of bleeding pattern on overall satisfaction as part of a phase 3 trial of a radiopaque contraceptive implant. Materials: Etonogestrel implant (Implanon NXT, Merck, USA). Methods: Participants (n = 301) in this open-label, non-controlled trial (NCT00620035), were fully informed about the product and asked whether they expected to experience any of 9 specified favourable (e.g. lighter bleeding than usual) or unfavourable (e.g. unpredictable) bleeding aspects before implant insertion. During treatment and at implant removal, women indicated whether they experienced these aspects and rated their impact on overall satisfaction with the implant (scale 1 to 5, from very negative to very positive). Results: In total, 156 (52%) women completed the 3-year study, 58 (19%) discontinued due to bleeding irregularities, and 87 (29%) discontinued due to other reasons (non-bleeding adverse events, personal reasons, loss to follow-up). Three favourable (amenorrhoea, less frequent, lighter bleeding) and 3 unfavourable (spotting, unpredictable, irregular bleeding) aspects were experienced by fewer women than expected prior to implant insertion. Painful bleeding occurred as expected, and prolonged
implanon inserted between 4 to 10 weeks of pospartum and were follow-up after 3 months and six months after the insertion. Results: There were 33 women enrolled in the study. Mean age of the patients was 30 years (range 24–41 years). Of those, 17 patients delivered by caesarean section while 16 patients had vaginal delivery. During first visit, 57.6% had amenorrhoea, 21.2% had prolonged bleeding while the incidence of normal, and irregular bleeding were 15.1% and 6.1% respectively. In second visit, 63.6% had amenorrhoea, 6.1% had prolonged bleeding while the incidence of normal and irregular bleeding were 21.2% and 9.1% respectively. Only two patients seek medical treatment due to prolonged bleeding. 28 patients continue to breast fed their babies while 5 patients stopped breast feeding while on implanon. The majority of women expressed satisfaction to her implano® use, only three patients were not satisfied mainly due to side-effects of prolonged or irregular bleeding. There was no removal after six months follow-up. Conclusions: Implano® is a good, well accepted long-term contraceptive method for post partum women and lactating mothers. Dissatisfaction of its use is mainly due to abnormal menstrual bleeding pattern. M122 LIPID PROFILE OF WOMEN ON EXTENDED REGIMENS OF COMBINED ORAL CONTRACEPTIVES: DO DIFFERENT TYPES OF PROGESTOGENS MAKE A DIFFERENCE? C.A. Guazzelli1 , F. Barreiros2 , R. Barbosa3 , M.R. Torloni1 , M. Barbieri1 , F. Assis2 , F.F. Araujo1 . 1 S˜ ao Paulo Federal University, S˜ ao Paulo, S˜ ao Paulo, Brazil; 2 Oeste Paulista University, Presidente Prudente, S˜ ao Paulo, Brazil; 3 School of Nursing, S˜ ao Paulo University, S˜ ao Paulo, S˜ ao Paulo, Brazil Objectives: The effects of extended regimens of combined oral contraception on clinical symptoms have been extensively studied but there are comparatively few studies on their metabolic effects. We aimed to assess and compare the lipid profile of women on extended regimens of combined oral contraceptives containing two different types of progestogens. Materials: This study enrolled 150 adult women (18–40 years) managed in 2011 at the same gynecology clinic of Oeste Paulista Universtity. Methods: Participants were randomized to take daily pills containing 30 mcg ethinylestradiol and either 75 mcg gestodene (Gr 1) or 150 mcg desonogestrel (Gr 2), continuously for 84 consecutive days followed by a 7 days pill-free interval, during 6 months. Exclusion criteria followed the WHO recommendations. Blood was collected at baseline and at three months intervals to assess total cholesterol, HDL-C, LDL-C, and triglycerides. The ANOVA test was used to compare results of these exams over time. Results: Patient characteristics did not differ between the two groups and the number of dropouts was similar (16% and 12%). There were no pregnancies during the study period. Total cholesterol, LDL-C, HDL-C and triglycerides levels increased slightly hroughout the study period in both groups, but did not differ significantly between the groups. Conclusions: Women on extended regimens of combined oral contraceptives for 6 months have similar changes in their lipid profile regardless of the type of progestagen used. M123 DIABETES MELLITUS AND CONTRACEPTION O. Tanko1 , M.V. Samoylova2 , G. Maltsev1 , E. Blagoveschenskiy1 . 1 Obstetrics and Gynecology #2, Kharkiv National Medical University, Kharkiv, Ukraine; 2 National O.O. Bohomolets Medical University, Kyiv, Ukraine Objectives: In recent ages in the world the steady growth of illness with diabetes mellitus becomes perceptible. Pregnancy with diabetes mellitus is accompanied by the high complications
S571
number, increasing perinatal death rate. That is why prevention of unwanted pregnancy, planning of possible pregnancy in the illness compensation phase are the important questions of contemporary reproductology. The aim of the research was a dynamic observation of hemostasis parameters in patients with diabetes mellitus type I on the basis of oral contraceptives (OC) containing estradiol valerate (E2V)/dienogest (DNG) taking. Materials: Patients with diabetes mellitus type I in the age up to 35 years were observed. Besides patients with high body mass index (BMI), hypertension, diabetes retinopathy, nephropathy and other vascular complications were excluded. Methods: For hemostasis system learning functional activity of thrombocytes, coagulative potential of blood and level of endothelin-1 were studied. Results: During estimation of hemostasis system on the basis of three months OC containing E2V/DNG taking in 12.5% of women with diabetes mellitus type I we noted extension of adenosindiphosphoric (ADP)-induced thrombocytes aggregation (p < 0.05), in 9.4% of women we observed some gain in coagulative potential of blood with Activated Partial thromboplastin time (APTT) shortening, increasing of fibrinogen concentration (p < 0.01). Tendency to endotheling-1 level extension was noted in 15.6% of women. However we didn’t find any thrombophylic complications on this stage among observed women. Described hemostasis system profile changed on the ninth month of OC containing E2V/DNG taking. During this period in observed women thrombocytes aggregation intensiveness lowering was noted. Changes in plasmatic factors of hemostasis were characterized by the APTT prolongation, lowering of fibrinogen level up to the physiologic values. Endothelin-1 level was higher comparing to the control only in two patients. Hence while prolonging time of OC containing E2V/DNG taking to the nine months we noted gradual restoration of coagulative blood system markers, rheologic blood features improvement, endothelial dysfunction elimination. Conclusions: Patients with non-complicated diabetes mellitus type I demonstrated favorable OC containing E2V/DNG acceptability profile while using it for contraceptive purposes. M124 WOMEN’S EXPECTATIONS AND SATISFACTION ON BLEEDING PATTERN WHEN USING IMPLANON NXT F. Beligotti1 , E. Mommers1 , M. Marintcheva-Petrova1 . 1 Merck Sharp & Dohme, Oss, Netherlands Objectives: To assess women’s expected and actual bleeding pattern and the impact of bleeding pattern on overall satisfaction as part of a phase 3 trial of a radiopaque contraceptive implant. Materials: Etonogestrel implant (Implanon NXT, Merck, USA). Methods: Participants (n = 301) in this open-label, non-controlled trial (NCT00620035), were fully informed about the product and asked whether they expected to experience any of 9 specified favourable (e.g. lighter bleeding than usual) or unfavourable (e.g. unpredictable) bleeding aspects before implant insertion. During treatment and at implant removal, women indicated whether they experienced these aspects and rated their impact on overall satisfaction with the implant (scale 1 to 5, from very negative to very positive). Results: In total, 156 (52%) women completed the 3-year study, 58 (19%) discontinued due to bleeding irregularities, and 87 (29%) discontinued due to other reasons (non-bleeding adverse events, personal reasons, loss to follow-up). Three favourable (amenorrhoea, less frequent, lighter bleeding) and 3 unfavourable (spotting, unpredictable, irregular bleeding) aspects were experienced by fewer women than expected prior to implant insertion. Painful bleeding occurred as expected, and prolonged