Milena Bastos Brito

Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study.

BACKGROUND The effects of etonogestrel (ETG)-releasing contraceptive implant during the immediate postpartum period on maternal safety are unknown. STUDY DESIGN Forty healthy women exclusively breastfeeding were randomized to receive either ETG-releasing implant 24-48 h after delivery (n=20) or depot medroxyprogesterone acetate (DMPA group; n=20) at the sixth week postpartum. We measured blood pressure, maternal and neonatal weight, body mass index (BMI; kg/m(2)), waist circumference (WC), complete blood count, C-reactive protein, interleukin-6, tumor necrosis factor (TNF-alpha), lipid profile, fasting serum glucose and maintenance of exclusive lactation up to the 12th week postpartum. RESULTS Decreases in mean maternal weight, BMI (kg/m(2)) and WC were significantly greater in the ETG-releasing implant group than in the DMPA group during the first 6 weeks postpartum (-4.64+/-2.71 kg vs. -2.6+/-2.45 kg mean+/-SD, p=.017; -1.77+/-1.06 kg/m(2) vs. -0.97+/-0.95 kg/m(2), p=.026; -15.3+/-6.72 cm vs. -9.05+/-5.84 cm, p=.003, respectively). In addition, total cholesterol and HDL, were lower in DMPA users, and TNF-alpha and leukocytes were higher in DMPA users compared to in the implant group, between 6 and 12 weeks after delivery. The newborns of implant users showed a trend towards gaining more weight, as compared with the infants of the DMPA mothers during the first 6 weeks of life (implant group: +1460.50+/-621.34 g vs. DMPA group: +1035.0+/-562.43 g, p=.05). The remaining variables, including the duration of exclusive breastfeeding, were similar between the groups. CONCLUSION The insertion of ETG-releasing contraceptive implant during the immediate postpartum period was not associated with deleterious maternal clinical effects or with significant maternal metabolic alterations or decreased infant weight gain.

Effect of antiretroviral therapy including lopinavir/ritonavir or efavirenz on etonogestrel-releasing implant pharmacokinetics in HIV-positive women.

Objective:Data on the interaction between the etonogestrel (ENG) implant and antiretroviral therapy are lacking. We evaluated the effect of 2 highly active antiretroviral therapy (HAART) regimens (1 including efavirenz and the other ritonavir-boosted lopinavir) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in HIV-positive women. Design:Prospective nonrandomized PK study. Methods:Forty-five HIV-positive women who desired to use ENG implants were included: 15 had received zidovudine/lamivudine + lopinavir/ritonavir for ≥3 months (LPV/r-based HAART group), 15 had received zidovudine/lamivudine + efavirenz for ≥3 months (EFV-based HAART group), and 15 had not received HAART (non-HAART group). PK parameters were measured using ultra-performance liquid chromatography–mass spectrometry at baseline and 2, 4, 6, 8, 10, 12, 16, 20, and 24 weeks after implant placement. Results:The EFV-based HAART regimen was associated with a reduction in the bioavailability of ENG, which showed decreases of 63.4%, 53.7%, and 70% in the area under the curve (AUC), maximum concentration (Cmax), and minimum concentration (Cmin) of ENG, respectively, compared with the non-HAART group. The LPV/r-based HAART regimen was associated with an increase in ENG bioavailability, which showed 52%, 60.6%, and 33.8% increases in the ENG AUC, Cmax, and Cmin, respectively, compared with the non-HAART group. Conclusions:The coadministration of EFV decreased the bioavailability of ENG released from the implant, which could impair contraceptive efficacy. However, the coadministration of LPV/r increased the bioavailability of ENG released from the implant, which suggests that this antiretroviral combination does not impair the ENG implant efficacy.

Hormonal contraception and cardiovascular system

Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.

Contracepção hormonal e sistema cardiovascular

Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.

Effects of the etonogestrel-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis: a randomized controlled trial.

INTRODUCTION The puerperium is the period of highest risk for thrombosis during a womans reproductive life and it is an important time for initiating an effective contraceptive method in order to increase intergestational interval. Thus, the objective of the present study was to evaluated the effects of the etonogestrel (ENG)-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis markers during the first six weeks of delivery. MATERIALS AND METHODS Forty healthy women aged 18 to 35 years-old were randomized to receive either the ENG-releasing implant 24-48 h after delivery (implant group; n=20) or nothing (control group) until the sixth postpartum week. Blood samples were collected at 24-48 h and at 6 weeks after delivery, and hemostatic variables, including fibrinogen, coagulation factors, protein C, free protein S, antithrombin, α2-antiplasmin, plasminogen activator inhibitor 1, thrombin-antithrombin complex (TAT), prothrombin fragment (PF)1+2, and D-dimers, as well as normalized activated protein C sensitivity ratio (nAPCsr), thrombin time, activated partial thromboplastin time, and prothrombin time were evaluated. RESULTS Insertion of the ENG-releasing contraceptive implant did not change the physiological reduction in overall coagulation (TAT and PF1+2) and fibrinolysis (D-dimer) markers, or nAPCsr. Reductions in factors II, VII, X and fibrinogen and increases in factor V were greater in the control than in the implant group. Clotting factors remained within normal limits throughout the study. CONCLUSION The ENG-releasing contraceptive implant inserted immediately postpartum did not have negative effects on physiological variations of the hemostatic system during the first 6 weeks postpartum.

Contracepção no puerpério

Uma adequada contracepcao no puerperio e recomendada para prevenir morbidades maternas e infantis. Os beneficios materno-fetais da lactacao sao indiscutiveis e a amamentacao exclusiva em pacientes amenorreicas e um metodo contraceptivo eficaz. No entanto, o reinicio da fertilidade e variavel entre as mulheres e deve-se considerar que o acesso ao servico de saude em muitas regioes nao e garantido, comprometendo a prescricao de um metodo eficaz, quando ocorre o retorno dos ciclos ovulatorios. Foram pesquisados no Medline (PubMed) os artigos relacionados ao tema publicados entre 1971 e abril de 2008 e selecionados os artigos relevantes na literatura sobre contracepcao no puerperio. Curtos intervalos intergestacionais aumentam complicacoes maternas e fetais, portanto uma contracepcao eficaz no puerperio e imperiosa. O ideal e que o metodo prescrito seja eficaz e seguro (nao interfira na lactacao e nem altere o sistema hemostatico). Apesar do metodo contraceptivo da lactacao-amenorreia representar um metodo eficaz de prevencao de gestacao, o retorno a fertilidade e impreciso. Em populacoes de risco para intervalo intergestacional curto e/ou acesso dificil ao servico de saude, outros metodos deverao ser associados apos seis semanas, como os nao hormonais ou os de progestagenios isolados, podendo ser utilizados antes em situacoes especiais.

Bleeding patterns of HIV-infected women using an etonogestrel-releasing contraceptive implant and efavirenz-based or lopinavir/ritonavir-based antiretroviral therapy.

Abstract Objectives: The use of progestogen-only contraceptives may cause a change in bleeding pattern, which is a common cause of discontinuation of these methods. Co-administration with some antiretroviral therapies (ART) changes the bioavailability of the etonogestrel (ENG)-releasing contraceptive implant, possibly affecting the bleeding pattern. Bleeding patterns were evaluated in HIV-positive users of the ENG implant co-administered with two common ART regimens. Methods: Forty-five HIV-positive women who wished to use an ENG implant were included in this study: 15 had received zidovudine/lamivudine (AZT/3TC) + lopinavir/ritonavir (LPV/r) for ≥3 months (LPV/r-based ART group), 15 had received AZT/3TC + efavirenz (EFV) for ≥3 months (EFV-based ART group), and 15 had not received ART (non-ART group). Bleeding patterns were evaluated at 3 and 6 months after implant placement using a standard bleeding calendar. Results: Amenorrhoea and infrequent bleeding rates were higher in the LPV/r-based ART group (50% and 36%, respectively) than in the other groups (non-ART group, 36% and 29%, respectively; EFV-based ART group, 7% and 14.5%, respectively; p = 0.01). The EFV-based ART group more frequently had regular bleeding (71.5%) compared with the other groups (LPV/r-based ART group, 7%; non-ART group, 21%; p = 0.01). The proportions of women with frequent and prolonged bleeding were similar (p > 0.05) in the three groups. Conclusions: The co-administration of EFV-based or LPV/r-based ART with the ENG implant affected the expected bleeding patterns during use of the implant, although unfavourable bleeding (frequent and prolonged) was not associated with the medications under evaluation.

Effect of Coadministration of Etonogestrel Implant and AntiretroviralTherapies Containing Efavirenz or Lopinavir/Ritonavir on the Metabolismof Women Living with HIV/AIDS

Background: Concomitant use of antiretroviral therapy (ART) and hormonal contraceptives should be safe for women while maintaining medication efficacy without causing significant immunological or metabolic changes. However, the metabolic effect of the concomitant use of etonogestrel (ENG)-releasing implant and commonly used ARTs is not known. Objective: To evaluate the effect of coadministration of ENG-releasing implant and ARTs containing lopinavir/ ritonavir or efavirenz on the metabolic parameters of women living with human immunodeficiency virus (HIV) infection/ acquired immune deficiency syndrome (AIDS). Methods: This is an open, prospective, non-randomized exploratory study. Forty-five women who sought to receive the ENG contraceptive implant were selected, including 15 non-ART users, 15 zidovudine/lamivudine (AZT/3TC)+lopinavir/ritonavir users and 15 AZT/3TC+efavirenz users for at least 3 months. Clinical and metabolic parameters were assessed before, during and 24 weeks after implant insertion. Results: At 24 weeks after ENG implant insertion, the group without ART showed a 4.7% increase in albumin level (p=0.03), a 6.2% decrease in total cholesterol level (p=0.03) and a 5.6% increase in alkaline phosphatase level (p<0.01), whereas the lopinavir/ritonavir group showed a 12.5% increase in aspartate aminotransferase (p=0.03). The efavirenz group showed a 12.9% decrease in low-density lipoprotein (p=0.03). The other results showed no significant changes during the 24 week study. The observed changes remained within the normal values for the parameters. Conclusion: Co-administration of ENG implant with ARTs containing lopinavir/ritonavir or efavirenz is not associated with clinically relevant metabolic changes in women living with HIV infection/AIDS, after a 6 month followup period.

Comparison of the hemostatic effects of a levonorgestrel-releasing intrauterine system and leuprolide acetate in women with endometriosis: a randomized clinical trial.

INTRODUCTION The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic inflammatory disease affecting 10% of women. The objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis: the levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog (GnRHa) leuprolide acetate. MATERIALS AND METHODS In this randomized open-label controlled trial, 44 women with endometriosis were randomly allocated to one of two groups: 22 women were assigned to use LNG-IUS and 22 to use GnRHa. The assessed variables were D-dimers, fibrinogen, prothrombin time, activated partial thromboplastin time, coagulation factors (F) II, V, VII, VIII, IX, X, and XI, antithrombin (AT), protein C, free protein S, tissue plasminogen activator (t-PA), α2-antiplasmin, thrombin-antithrombin complex, and prothrombin fragment 1+2. All variables were assessed before treatment and six months after treatment onset. RESULTS In the LNG-IUS group, FVIII decreased 10% after six months of use. In the GnRHa group, there was a 6% increase in AT, 29% reduction in D-dimers, and 19% increase in t-PA. The LNG-IUS users exhibited a significantly greater reduction of FVIII than the GnRHa users (LNG-IUS: -6.4 ± 14.3% vs. GnRHa: 4.2 ± 12.3%, p=0.02). The women in the GnRHa group exhibited a greater increase of AT than the LNG-IUS users (LNG-IUS: -0.7 ± 9.5% vs. GnRHa: 6.5 ± 10.1%, p=0.02). CONCLUSION Both hormonal treatments for endometriosis exhibited no association with a procoagulant profile.

Contracepción hormonal y sistema cardiovascular

Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.Hormonal contraception is the most widely used method to prevent unplanned pregnancies. The literature has shown an association between cardiovascular risk and use of hormone therapy. With the purpose of providing better guidelines on contraception methods for women with risk factors for cardiovascular disease, we have reviewed the literature on the subject. This review describes the latest data from the scientific literature concerning the influence of hormonal contraceptives on arterial thrombosis, venous thrombosis and systemic high blood pressure, which are diseases that have become increasingly prevalent among young females.