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Title: Headache induced by the use of combined oral contraceptives.
Author: Allais G; Gabellari IC; Airola G; Borgogno P; Schiapparelli P; Benedetto C
Source: Neurological Sciences. 2009 May;30 Suppl 1:S15-7.
Abstract: Although combined oral contraceptives (COCs) are a safe and highly effective method of birth control, they may also give rise to problems of clinical tolerability in migraine patients. Indeed, headache is among the most common side effects reported with the use of COCs, frequently leading to their being discontinued. The latest International Classification of Headache Disorders identified at least two entities evidently related to the use of COCs, i.e., exogenous hormone-induced headache and estrogen-withdrawal headache. As to the former, the newest formulations of COCs are generally well tolerated by migraine without aura patients, but can worsen headache in migraine with aura patients. Headache associated with COCs, generally, tends to improve as their use continues. However, although it is not yet clear if there is an association between headache and the composition of COCs (both in the type and amount of hormones), it has been observed that the incidence of headache during COC use seems greater if migraine is associated with menstrual trigger. The estrogen-withdrawal headache is a headache that generally appears within the first 5 days after cessation of estrogen use and resolves within 3 days, even if in some cases it may appear on the sixth or seventh day after pill suspension and lasts more than 3 days.
Language: English

Keywords:
ITALY | LITERATURE REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | HEADACHE | MIGRAINE | INCIDENCE | HORMONES | ESTROGENS | Developed Countries | Europe, Southern | Europe | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Signs and Symptoms | Diseases | Vascular Diseases | Measurement | Research Methodology | Endocrine System | Physiology | Biology
Document Number: 342617  

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Title: Oral contraceptives in migraine.
Author: Allais G; Gabellari IC; De Lorenzo C; Mana O; Benedetto C
Source: Expert Review of Neurotherapeutics. 2009 Mar;9(3):381-93.
Abstract: Combined oral contraceptives are a safe and highly effective method of birth control, but they can also raise problems of clinical tolerability and/or safety in migraine patients. It is now commonly accepted that, in migraine with aura, the use of combined oral contraceptives is always contraindicated, and that their intake must also be suspended by patients suffering from migraine without aura if aura symptoms appear. The newest combined oral contraceptive formulations are generally well tolerated in migraine without aura, and the majority of migraine without aura sufferers do not show any problems with their use; nevertheless, the last International Classification of Headache Disorders identifies at least two entities evidently related to the use of combined oral contraceptives: exogenous hormone-induced headache and estrogen-withdrawal headache. As regards the safety, even if both migraine and combined oral contraceptive intake are associated with an increased risk of ischemic stroke, migraine without aura per se is not a contraindication for combined oral contraceptive use. Other risk factors (tobacco use, hypertension, hyperlipidemia, obesity and diabetes) must be carefully considered when prescribing combined oral contraceptives in migraine without aura patients, in particular in women aged over 35 years. Furthermore, the exclusion of a hereditary thrombophilia and of alterations of coagulative parameters should precede any decision of combined oral contraceptive prescription in migraine patients.
Language: English

Keywords:
ITALY | RESEARCH REPORT | CLIENTS | WOMEN | MIGRAINE | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE SAFETY | CONTRACEPTIVE USE-EFFECTIVENESS | Developed Countries | Europe, Southern | Europe | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Vascular Diseases | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Health | Contraceptive Effectiveness
Document Number: 330561  

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Peer Reviewed

Title: Hormonal contraception, sickle cell trait, and risk for venous thromboembolism among African American women.
Author: Austin H; Lally C; Benson JM; Whitsett C; Hooper WC; Key NS
Source: American Journal of Obstetrics and Gynecology. 2009 Jun;200:620e1-620e3.
Abstract: OBJECTIVE: We evaluated the effect of oral and other hormonal contraceptive (HC) use on venous thromboembolism risk among African American women and investigated whether the association was modified by the sickle cell trait. STUDY DESIGN: We report the findings of a case-control study that included 60 African American women with an idiopathic, first episode of venous thromboembolism and 196 African American controls. RESULTS: The odds of current HC use compared with noncurrent use contrasting cases and controls is 3.8 (95% confidence interval [CI], 1.7-8.1; P < .001). Among subjects with sickle cell trait, the odds ratio is higher (odds ratio [OR], 6.7; 95% CI, 1.0-43) than the odds ratio among subjects without sickle cell trait (OR, 2.6; 95% CI, 1.1-6.2), but the difference is not statistically significant. CONCLUSION: This study provides persuasive evidence that hormonal contraceptive use increases venous thromboembolism risk among African American women and that the increase in risk may be larger among women with sickle cell trait.
Language: English

Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | CASE STUDIES | BLACKS | WOMEN | CONTRACEPTION | CONTRACEPTIVE AGENTS | THROMBOEMBOLISM | DISEASES | RISK FACTORS | Developed Countries | North America | Americas | Studies | Research Methodology | Ethnic Groups | Cultural Background | Population Characteristics | Demographic Factors | Population | Family Planning | Embolism | Vascular Diseases | Health
Document Number: 330853  

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Title: Limited knowledge on progestogen-only contraception and risk of venous thromboembolism.
Author: Bergendal A; Odlind V; Persson I; Kieler H
Source: Acta Obstetricia et Gynecologica Scandinavica. 2009;88(3):261-266.
Abstract: Objective. To assess the current knowledge concerning progestogen-only contraception (POC) and risks of venous thromboembolism (VTE). Design and setting. Systematic review of the literature on observational and analytical studies reporting risk estimates for VTE in women exposed to POCs. Methods and main outcome measures. We performed a computerized literature search in the Pub Med, Embase, and the Cochrane Library for studies published between 1966 and February 13, 2008. Based on the evaluated studies we calculated an overall risk estimate for VTE in association with POC. Results. Four case-control studies and one cohort study were included. Of the case-control studies, three reported an increased risk and one a decreased risk of VTE. The cohort study found divergent results depending on the type of statistical analysis used. None of the results was statistically significant. The overall odds ratio for POC-associated VTE in the four case-control studies was 1.45 (95% CI=0.92-2.26). Conclusions. The risk of VTE associated with use of POCs is poorly investigated. The slightly elevated overall risk estimate might suggest an association between POC and an increased risk for VTE. The results must, however, be interpreted with caution due to the possibility of residual confounding. Well-designed studies with sufficient statistical power to evaluate risks of VTE with POC are warranted.
Language: English

Keywords:
SWEDEN | RESEARCH REPORT | EPIDEMIOLOGY | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | THROMBOEMBOLISM | RISK FACTORS | KNOWLEDGE | Europe, Northern | Europe | Developed Countries | Public Health | Health | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Embolism | Vascular Diseases | Diseases | Sociocultural Factors
Document Number: 329655  

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Title: Risk factors for deep vein thrombosis in women aged 18 to 50: a retrospective analysis.
Author: Binder B; Lackner HK; Salmhofer W; Hofmann-Wellenhof R
Source: Dermatologic Surgery. 2009 Mar;35(3):451-6.
Abstract: BACKGROUND: Deep vein thrombosis (DVT) occurs in one of every 1,000 individuals per year. Various inherited and acquired risk factors are known. We investigated the importance of oral contraceptives (OCs) as a risk factor in women of child-bearing age. OBJECTIVES: To evaluate the risk factors for DVT in a female patient collective. METHODS: We analyzed the records of 99 women aged 18 to 50 with DVT. We documented age, identifiable risk factor of DVT, location of the thrombus, use of OCs, and thrombophilia. RESULTS: 52.5% of patients suffering from DVT were aged between 40-50 years. Forty-six patients had an unprovoked DVT; the most common risk factor was immobilization in 41. Thrombophilia was found in 18 cases. Twenty-nine patients used OCs; no influence of OCs on any of the other risk factors was found. CONCLUSIONS: In our patient group, the most important risk factors were older age and immobilization. DVT is typically idiopathic and may be caused by subtle nondetectable thrombophilic disorders. The use of OCs was distributed in DVT patients just as in the general Austrian community and seems not to be a severe additional risk factor. Examining the whole lower extremity during ultrasonography is important so as not to overlook a DVT of the lower leg.
Language: English

Keywords:
AUSTRIA | RESEARCH REPORT | RETROSPECTIVE STUDIES | WOMEN | PREGNANT WOMEN | THROMBOSIS | AGE FACTORS | RISK FACTORS | Developed Countries | Europe, Central | Europe | Studies | Research Methodology | Demographic Factors | Population | Population Characteristics | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health
Document Number: 331221  

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Peer Reviewed

Title: Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: Does it make a difference in the mind and the daily practice of gynaecologists and general practitioners?
Author: Bitzer J; Frey B; von Schonau M; Sabler N; Tschudin S
Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun 5;:1-10.
Abstract: Objectives Currently, evidence-based guidelines concerning the use of oral contraceptives (OCs) containing either 20 or 30 mug ethinyloestradiol (EE) and the same progestogen, are lacking. We wanted to identify whether Swiss gynaecologists and general practitioners (GPs) have specific criteria on which they base their prescribing habit. Methods Two questionnaires were submitted to 158 physicians. The first one contained a list of possible criteria relevant for decision making and a description of specific clinical situations. The second one concerned actual patients who received either a 20 mug (Yasminelle(R)) or a 30 mug (Yasmin(R)) OC containing the same progestogen drospirenone. Results The most relevant criteria for decision making (in hierarchical order) were family history of venous thromboembolic disease (VTE), headache, smoking, age beyond 35, stability of the menstrual cycle, breast tenderness, body mass index, irregular bleeding and acne. The 20 mug dosage was preferred for women older than 35, those smoking more than 15 cigarettes per day, those with a family history of VTE, and those complaining of breast tenderness or headache. The 30 mug dosage was preferred for patients with a history of irregular bleeding, a family history of osteoporosis, expected poor compliance and acne. Conclusion Swiss gynaecologists and GPs do not preferentially prescribe the lowest possible dosage of EE. They use indirect markers they consider relevant for differential prescribing. For some markers, there is inconsistency, indicating that preferences for 20 mug and 30 mug preparations may be influenced by other factors.
Language: English

Keywords:
SWITZERLAND | RESEARCH REPORT | PHYSICIANS | WOMEN | CLIENTS | DECISION MAKING | TOBACCO USE | HEADACHE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, SIDE EFFECTS | THROMBOEMBOLISM | AGE FACTORS | ADMINISTRATION AND DOSAGE | Developed Countries | Europe, Central | Europe | Health Personnel | Delivery of Health Care | Health | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Behavior | Signs and Symptoms | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Embolism | Vascular Diseases | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services
Document Number: 341601  

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Peer Reviewed

Title: Effect of human immunodeficiency virus treatment on maternal mortality at a tertiary center in South Africa: a 5-year audit.
Author: Black V; Brooke S; Chersich MF
Source: Obstetrics and Gynecology. 2009 Aug;114(2 Pt 1):292-9.
Abstract: OBJECTIVE:: To review facility-based maternal deaths at a tertiary-level center in Johannesburg, South Africa, during a 5-year period (2003 to 2007) and to investigate the proportion of deaths attributable to human immunodeficiency virus (HIV), the etiology of deaths, and the effects of antiretroviral treatment introduced in late 2004. METHODS:: Patient case files, birth registers, death certificates, and mortality summaries were reviewed. Cause of death was assigned through clinical case discussion. Annual maternal mortality ratios were calculated and disaggregated by HIV status. RESULTS:: During the 5-year period, 106 maternal deaths occurred out of 36,708 births (facility-based maternal mortality ratios 289/100,000 live births, 95% confidence interval [CI] 237-349/100,000). In 72% of cases, HIV status was known (76/106), with the majority being HIV-infected (78%, 59/76). Among HIV-infected women, only two had initiated antiretroviral treatment, and 70% of deaths were HIV-related (41/59), mainly from tuberculosis (21) and pneumonia (12). Direct obstetric causes of death such as hypertension and pregnancy-related sepsis predominated in women who were HIV-negative or of unknown status (48.9%, 23/47). Maternal mortality ratios in HIV-infected women were 776/100,000 (95% CI 591-1,000/100,000), 6.2-fold higher (95% CI 3.6-11.4) than in HIV-negative women (124/100,000, 95% CI 72-199/100,000). Changes in mortality over time were not detected. Although HIV testing increased 1.4-fold each year (95% CI 1.3-1.4) and estimated coverage of antiretroviral treatment for pregnant women reached 59.2% in 2007, levels remain suboptimal. CONCLUSION:: In Johannesburg, HIV remains the major cause of maternal mortality despite integration of antiretroviral treatment into prenatal services. Maternal health services should target barriers to uptake of HIV treatment and care. LEVEL OF EVIDENCE:: III.
Language: English

Keywords:
SOUTH AFRICA | RESEARCH REPORT | PREGNANT WOMEN | HYPERTENSION | MATERNAL-CHILD HEALTH SERVICES | HIV INFECTIONS | AIDS | MATERNAL MORTALITY | CAUSES OF DEATH | HIV/FP INTEGRATION | TREATMENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Population Characteristics | Demographic Factors | Population | Vascular Diseases | Diseases | Primary Health Care | Health Services | Delivery of Health Care | Health | Viral Diseases | Mortality | Population Dynamics | Medical Procedures | Medicine
Document Number: 342270  

8.
Title: Venous thromboembolism in women using hormonal contraceptives. Findings from the RIETE Registry.
Author: Blanco-Molina A; Trujillo-Santos J; Tirado R; Canas I; Riera A; Valdes M; Monreal M
Source: Thrombosis and Haemostasis. 2009;101(3):478-482.
Abstract: There is scarce information on the clinical characteristics of contraceptive users who develop venous thromboembolism (VTE). RIETE is an ongoing registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We analyzed the clinical characteristics and additional risk factors for VTE in all enrolled women aged <50 years who were using or not using contraceptives at presentation with VTE. Of 1,667 women aged <50 years enrolled in RIETE as of December 2007, 593 (36%) were contraceptive users. Of 270 aged <25 years, 190 (70%) were users. Ninety-two contraceptive users (16%) had overweight, 89 (15%) were obese. Of 951 women with no additional risk factors for VTE (i.e. recent surgery, immobility or cancer) 457 (48%) were contraceptive users. Eighty-seven (15%) users had recent immobility for >/=4 days, 44 (7.4%) were postoperative. The most common reason for immobility was lower limb trauma not requiring surgery; 25% of users with recent immobility had received thromboprophylaxis. The most common type of surgery was non-major orthopaedic surgery. Twenty-one (48%) users with postoperative VTE had received prophylaxis. The percentage of users and non-users who tested positive for thrombophilia was similar. Contraceptive use remains the most frequent risk factor for VTE in women at fertile age. Identifying those at increased risk for VTE seems to be difficult. In the meanwhile, a higher use of thromboprophylaxis during immobility or minor surgery should be warranted.
Language: English

Keywords:
SPAIN | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | PREVALENCE | THROMBOEMBOLISM | RISK FACTORS | CONTRACEPTIVE AGENTS, FEMALE | HORMONES | SIDE EFFECTS | COMPLICATIONS | SURGERY | POSTOPERATIVE PROCEDURES | Developed Countries | Europe, Southwestern | Europe | Research Methodology | Demographic Factors | Population | Measurement | Embolism | Vascular Diseases | Diseases | Health | Contraceptive Agents | Contraception | Family Planning | Endocrine System | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care
Document Number: 330607  

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Peer Reviewed

Title: [Spatial distribution of elderly individuals in a medium-sized city in São Paulo State, Brazil, according to key socio-demographic and morbidity characteristics] Distribuição espacial dos idosos de um município de médio porte do interior paulista segundo algumas características sócio-demográfi cas e de morbidade.
Author: Campos FG; Barrozo LV; Ruiz T; Cesar CL; Barros MB; Carandina L; Goldbaum M
Source: Cadernos de Saude Publica. 2009 Jan;25(1):77-86.
Abstract: Geographic Information Systems serve as important public health tools for analyzing population disease distribution and thus for identifying individuals with chronic non-communicable diseases. The current study performed a spatial analysis of the distribution of the population 60 years and older in the city of Botucatu, São Paulo State, Brazil, studying the socio-demographic profile and the presence of diabetes mellitus and arterial hypertension. Data were analyzed from 468 elderly individuals from a population survey conducted in 2001-2002. Elders with the highest socioeconomic status live in the census tracts with the highest social strata, as proven statistically by spatial analysis techniques for income and schooling. No spatial distribution pattern was found for elderly individuals with hypertension and diabetes, who were located heterogeneously on the map. The study suggests the use of geoprocessing techniques for digital mapping of areas covered by primary health care units, aimed at better monitoring of the distribution of elderly individuals with chronic diseases and their care by health professionals.
Language: Portuguese

Keywords:
BRAZIL | RESEARCH REPORT | EPIDEMIOLOGY | GEOGRAPHIC FACTORS | POPULATION DISTRIBUTION | DISEASES | HYPERTENSION | DIABETES | SOCIOECONOMIC STATUS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Public Health | Health | Population | Vascular Diseases | Socioeconomic Factors | Economic Factors
Document Number: 341870  

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Title: Massive Pulmonary Embolism Associated With Factor V Leiden, Prothrombin, and Methylenetetrahydrofolate Reductase Gene Mutations in a Young Patient on Oral Contraceptive Pills: A Case Report.
Author: Charafeddine KM; Mahfouz R; Ibrahim G; Taher A; Hoballah J; Taha A
Source: Clinical and Applied Thrombosis / Hemostasis. 2009 Jun 10;
Abstract: Factor V Leiden (Factor V G1691A), prothrombin gene mutation G20210A, and homozygous C677T mutation in the methylenetetrahydrofolate reductase (MTHFR) gene are known to predispose venous thromboembolism (VTE). We present herein a rare case of a young woman heterozygous for these mutations and taking oral contraceptive pills for less than 2 months, diagnosed to have massive deep venous thrombosis and bilateral pulmonary embolism. The patient was managed for 10 days in the hospital and discharged home on oral anticoagulants. This case suggests that screening for these factors in people with family history of thrombosis and in relatives of patients with these mutations is highly recommended to prevent fatal consequences. In addition, a new guideline for treatment and prophylaxis with anticoagulant for these patients and others who are at risk of developing VTE (American College of Chest Physicians [ACCP] guidelines-Chest 2008) has been published recently. Our recommendation is to promote for the internationally published algorithms through their application, where necessary, to prevent any future thrombotic morbidity or mortality incidents.
Language: English

Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | PREVALENCE | PULMONARY EMBOLISM | THROMBOEMBOLISM | MORBIDITY | Developed Countries | North America | Americas | Measurement | Research Methodology | Embolism | Vascular Diseases | Diseases
Document Number: 341600  

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Title: Women's health and gender-based clinical trials on etoricoxib: methodological gender bias.
Author: Chilet-Rosell E; Ruiz-Cantero MT; Horga JF
Source: Journal of Public Health. 2009 Sep;31(3):434-45.
Abstract: BACKGROUND: The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. METHODS: The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). RESULTS: Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors.
Language: English

Keywords:
GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTIVE AGENTS, FEMALE | HORMONE REPLACEMENT THERAPY | SIDE EFFECTS | THROMBOSIS | SEX FACTORS | PREGNANCY | VALIDITY | Clinical Research | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Thromboembolism | Embolism | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Reproduction | Measurement
Document Number: 342950  

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Title: Cerebral venous and sinus thrombosis in women.
Author: Coutinho JM; Ferro JM; Canhao P; Barinagarrementeria F; Cantu C; Bousser MG; Stam J
Source: Stroke. 2009 Jul;40(7):2356-61.
Abstract: BACKGROUND AND PURPOSE: Little is known about the gender-specific manifestations of cerebral venous and sinus thrombosis, a disease that is much more common in women than men. METHODS: We used data of the International Study on Cerebral Vein and Dural sinus Thrombosis (ISCVT), a multicenter prospective observational study, to analyze gender-specific differences in clinical presentation, etiology, and outcome of cerebral venous thrombosis. RESULTS: Four hundred sixty-five of a total of 624 patients were women (75%). Women were significantly younger, had less often a chronic onset of symptoms, and had more often headache at presentation. There were no gender differences in ancillary investigations or treatment. A gender-specific risk factor (oral contraceptives, pregnancy, puerperium, and hormonal replacement therapy) was present in 65% of women. Women had a better prognosis than men (complete recovery 81% versus 71%l P=0.01), which was entirely due to a better outcome in female patients with gender-specific risk factors. Women without gender-specific risk factors are similar to men in clinical presentation, risk factor profile, and outcome. Logistic regression analysis confirmed that the absence of gender-specific risk factors is a strong and independent predictor of poor outcome in women with sinus thrombosis (OR, 3.7; CI, 1.9 to 7.4). CONCLUSIONS: Our study identified important differences between women and men in presentation, course, and risk factors of cerebral venous and sinus thrombosis and showed that women with a gender-specific risk factor have a much better prognosis than other patients.
Language: English

Keywords:
GLOBAL | RESEARCH REPORT | PROSPECTIVE STUDIES | STATISTICAL REGRESSION | CLIENTS | WOMEN | CEREBROVASCULAR EFFECTS | THROMBOSIS | RISK FACTORS | SEX FACTORS | SIGNS AND SYMPTOMS | Studies | Research Methodology | Data Analysis | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Physiology | Biology | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health | Population Characteristics
Document Number: 342314  

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Peer Reviewed

Title: Safety of Contraceptive Method Use Among Women With Systemic Lupus Erythematosus: A Systematic Review.
Author: Culwell KR; Curtis KM; Del Carmen Cravioto M
Source: Obstetrics and Gynecology. 2009 Aug;114(2, Part 1):341-353.
Abstract: OBJECTIVE:: To evaluate the evidence on the safety of contraceptive method use among women with systemic lupus erythematosus (SLE). DATA SOURCES:: We searched the PubMed, MEDLINE, and LILACS databases for peer-reviewed articles published from database inception through January 2009, concerning the safety of contraceptive use among women with SLE. METHODS OF STUDY SELECTION:: We included studies that examined health outcomes among women using a contraceptive method after the diagnosis of SLE. The quality of each individual piece of evidence was assessed using the U.S. Preventive Services Task Force grading system. TABULATION, INTEGRATION, AND RESULTS:: Our search yielded 275 articles. A total of 14 articles that reported on 13 studies met our inclusion criteria. Available evidence, including two good-quality randomized controlled trials, indicates that use of combined oral contraceptives does not lead to increased flares of disease or worsening disease activity in women with inactive or stable active SLE. No increase in disease activity with use of progestogen-only contraceptives was noted in four studies. Limited evidence indicates a possible increased risk of thrombosis in women with positive antiphospholipid antibodies and history of oral contraceptive use. Limited evidence indicates that the use of the copper intrauterine device is not associated with worsening disease activity or infection in women with SLE. CONCLUSION:: Available evidence indicates that many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives. The benefits of contraception for many women with SLE likely outweigh the risks of unintended pregnancy in this population. Women with positive antiphospholipid antibodies are not good candidates for combined hormonal contraception given their elevated baseline risk of thrombosis.
Language: English

Keywords:
GLOBAL | LITERATURE REVIEW | CLIENTS | WOMEN | SYSTEMIC LUPUS ERYTHEMATOSUS | CONTRACEPTIVE METHODS | CONTRACEPTIVE SAFETY | RISK FACTORS | ANTIBODIES | CARDIOVASCULAR EFFECTS | THROMBOSIS | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Diseases | Contraception | Family Planning | Safety | Public Health | Health | Immunologic Factors | Immunity | Immune System | Physiology | Biology | Thromboembolism | Embolism | Vascular Diseases
Document Number: 342215  

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Peer Reviewed

Title: Use of contraceptive methods by women with current venous thrombosis on anticoagulant therapy: a systematic review.
Author: Culwell KR; Curtis KM
Source: Contraception. 2009 Oct;80(4):337-45.
Abstract: BACKGROUND: As nearly all women with venous thromboembolism (VTE) will be treated with anticoagulant therapy, it is important to consider how anticoagulation affects the safety of contraceptive use. STUDY DESIGN: We conducted a systematic review of the literature regarding use of contraceptive methods in women with current VTE on anticoagulant therapy. Due to the limited direct evidence that was identified, we expanded our search to include women on anticoagulant therapy for indications other than VTE and women with bleeding disorders. RESULTS: Six articles met our inclusion criteria. Three observational studies found the levonorgestrel-releasing IUD (LNG-IUD) was an effective treatment for menorrhagia for women on anticoagulation therapy or with bleeding disorders. Prevention of recurrent hemorrhagic ovarian cysts was seen in women on chronic anticoagulation treated with depot-medroxyprogesterone acetate (DMPA) in one small observational study. Among women with bleeding disorders, no complications were seen in 16 women with placement of the LNG-IUD. One pharmacokinetic study found no statistically significant interaction between combined oral contraceptives and warfarin. Other than one case report, no evidence was found regarding the risk of recurrent thrombosis in women on anticoagulation therapy using a contraceptive method. CONCLUSION: The majority of studies in this review examined treatment effects of the LNG-IUD or DMPA on complications of anticoagulation and found overall beneficial effects of their use in these circumstances. Minimal evidence in women with inherited bleeding disorders suggests that insertion of the LNG-IUD does not pose major bleeding risks in these women with appropriate management.
Language: English

Keywords:
GLOBAL | LITERATURE REVIEW | THROMBOSIS | COMPLICATIONS | DRUGS | IUD, HORMONE RELEASING | IUD SIDE EFFECTS | INSERTION | DEPO-PROVERA | BLOOD COAGULATION EFFECTS | HEREDITARY DISEASES | MENSTRUATION DISORDERS | CONTRACEPTIVE SAFETY | Thromboembolism | Embolism | Vascular Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | IUD | Contraceptive Methods | Contraception | Family Planning | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Hematological Effects | Hemic System | Physiology | Biology | Safety | Public Health
Document Number: 342773  

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Title: Thrombophilic conditions in the adolescent: the gynecologic impact.
Author: Dietrich JE; Yee DL
Source: Obstetrics and Gynecology Clinics of North America. 2009 Mar;36(1):163-75.
Abstract: As Virchow's triad suggests, a fine balance exists between the vascular wall, intravascular contents, and dynamic blood flow, such that a shift in this balance predisposes to thrombosis. Although thromboembolic events (TEs) are relatively infrequent in adolescents, the morbidity and mortality associated with TEs can be significant. Over the past 15 years, TEs and inherited and acquired thrombophilic conditions underlying them have become increasingly recognized in teens at risk, with combined hormonal contraception constituting one of the most significant of these risk factors. Therefore, managing gynecologic problems in teens who have thrombophilic conditions can be challenging. It is important to have a clear understanding about safe options available to help address adolescent gynecologic concerns in this setting and to manage situations collaboratively with a hematologist.
Language: English

Keywords:
UNITED STATES OF AMERICA | RECOMMENDATIONS | ADOLESCENTS, FEMALE | GYNECOLOGY | THROMBOSIS | RISK FACTORS | HEREDITARY DISEASES | CONTRACEPTIVE AGENTS, FEMALE | ORAL CONTRACEPTIVES, COMBINED | BLOOD COAGULATION EFFECTS | SCREENING | PROGESTERONE | CONTRACEPTIVE METHODS | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medicine | Health Services | Delivery of Health Care | Health | Thromboembolism | Embolism | Vascular Diseases | Diseases | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Hematological Effects | Hemic System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Progestational Hormones | Hormones | Endocrine System
Document Number: 342856  

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Peer Reviewed

Title: Eligibility criteria in venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users.
Author: Dore DD; Norman H; Seeger JD
Source: Obstetrics and Gynecology. 2009 Jul;114(1):175.
Abstract: An erratum printed in Obstetrics & Gynecology in June of 2008 corrected the stated eligibility criterion in a study of venous thromboembolism, myocardial infarction (MI), and stroke in transdermal contraceptive users reported by Cole and colleagues. Originally, it was reported that the authors excluded women with malignancies other than nonmelanoma skin cancer. The actual exclusion implemented was slightly broader: women with a neoplasm other than benign skin disorders. We applied the originally stated exclusion of women to the original study population, so that women with evidence in the claims data of malignancy other than nonmelanoma skin cancer (International Classification of Diseases, 9th revision: 140.xx-208.xx, except 173.xx) were excluded rather than the broader version actually implemented (International Classification of Diseases, 9th revision: 140.xx-239.xx, except 232.xx). There were approximately 423,000 women in the source population before application of exclusions, and 2.4% of them were excluded because of the nonmalignancy neoplasm codes used. In the originally reported case-control analysis comparing use of the transdermal contraceptive to norgestimate- containing oral contraceptives with 35 micrograms of ethinyl estradiol, the odds ratio (OR) for venous thromboembolism was 2.0 (95% confidence interval [CI] 1.0-4.1) overall and 2.4 (95% CI 1.1-5.5) after exclusion of women with high-risk factors and 2.1 (95% CI 0.3-15.5) for MI. No strokes were observed among transdermal contraceptive users. Application of the narrower exclusion criterion (consistent with the originally stated exclusion by Cole and colleagues), yielded six additional cases matched to 24 controls, leading to ORs for venous thromboembolism of 2.0 (95% CI 1.0-4.0) overall and 2.5 (95% CI 1.1-5.5) after exclusion of women with high-risk factors and 2.1 (95% CI 0.3-15.5) for MI. No strokes were observed in transdermal contraceptive users. The broader definition of neoplasm that was used for exclusion in the original analysis did not materially affect the observed association measures. This finding is consistent with the study design principle that the application of broader exclusions will lead to noticeably different estimates than application of narrower exclusions only in settings where the effect (not just the risk) among excluded participants is substantially different from what it is among included participants. (full-text)
Language: English

Keywords:
UNITED STATES OF AMERICA | CRITIQUE | THROMBOEMBOLISM | MYOCARDIAL INFARCTION | CEREBROVASCULAR EFFECTS | CONTRACEPTIVE IMPLANTS | Developed Countries | North America | Americas | Embolism | Vascular Diseases | Diseases | Heart Diseases | Physiology | Biology | Contraceptive Methods | Contraception | Family Planning
Document Number: 341716  

17.    Full text document

Title: The growing chronic disease burden: implications for reproductive health.
Author: Drake JK
Source: Outlook. 2009 Jul;26(1):8 p.
Abstract: Approximately 80 percent of deaths from chronic disease occur in low- and middle-income countries, where people tend to develop these diseases at younger ages, suffer longer, and die sooner. A recent analysis found that chronic disease is an "important cause of female death, even during childbearing years, and for women with young families." The newsletter provides background on the growing chronic disease burden in developing countries, and explores current and anticipated impacts of cardiovascular conditions, diabetes, and obesity on reproductive health. Examples include hypertension and diabetes in pregnancy and contraceptive choice and access for women with cardiovascular conditions and risk factors.
Language: English

Keywords:
DEVELOPING COUNTRIES | SUMMARY REPORT | EPIDEMIOLOGY | DISEASES | REPRODUCTIVE HEALTH | MATERNAL MORTALITY | DEATH RATE | HYPERTENSION | DIABETES | SCREENING | FAMILY PLANNING | TREATMENT | PREVENTION AND CONTROL | Public Health | Health | Mortality | Population Dynamics | Demographic Factors | Population | Vascular Diseases | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care
Document Number: 341982  

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Peer Reviewed

Title: Pill scare: communication conundrum.
Author: Edouard L
Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):121-2.
Abstract: Adverse publicity for combined oral contraceptives (COCs) has led to pill scares on numerous occasions such as reproductive cancers in 1983 and venous thromboembolism (VTE) in 1995. Misinformation should be avoided, especially through the correct interpretation of relative risk to avoid confusion and decrease unnecessary anxiety. Reassurance is usually important, as the absolute risk is infinitely small. The popular media are very effective for the prompt dissemination of information, and authoritative statements are useful for improving communications with providers, patients and public.
Language: English

Keywords:
ALGERIA | HISTORICAL REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | MISINFORMATION | FEAR | RISK ASSESSMENT | CANCER | THROMBOEMBOLISM | INFORMATION DISTRIBUTION | PUBLIC HEALTH | Africa, North | Africa | Developing Countries | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Health | Communication | Emotions | Psychological Factors | Behavior | Evaluation | Neoplasms | Diseases | Embolism | Vascular Diseases
Document Number: 341650  

19.
Title: Consequences of thrombophilia screening for life quality in women before prescription of oral contraceptives and family members of VTE patients.
Author: Eichinger S
Source: Hamostaseologie. 2009 Feb;29(1):110-1.
Abstract: A large number of hereditary and acquired alterations in the coagulation system that are associated with an increased risk of venous thrombosis have been described. Screening for these thrombophilic defects has become particularly popular in women before the prescription of oral contraceptives. The relevance of the results with regard to the management of the patients remains, however, to be questioned. In a recent review of six articles that were aimed to determine the nature and extent of psychological impact of thrombophilia screening, no valid conclusions could be drawn about the psychological impact due to heterogeneity of the data and lack of methodological accuracy. We performed a questionnaire-based study in 247 women with and in 132 women without factor V Leiden who were referred for factor V Leiden testing before oral contraceptive intake. A large proportion (76%) of the women reported being emotionally disturbed by genetic testing. 16% of women with wildtype factor V were discouraged from OC use, while 3% of women with factor V Leiden were encouraged to take OC. This indicates that recommendations after testing are not consistently driven by the test result, which compromises the quality of patient care. Given the large number of women who are taking oral contraceptives unequivocal guidelines for counseling prior to their prescription are urgently needed. These guidelines should integrate the risks and benefits of oral contraceptives but also the impact of screening on quality of life and aspects of counselling.
Language: English

Keywords:
AUSTRIA | RESEARCH REPORT | WOMEN | ORAL CONTRACEPTIVES | COUNSELING | THROMBOSIS | RISK FACTORS | SCREENING | GENETIC TECHNIQUES | EMOTIONS | QUALITY OF LIFE | Developed Countries | Europe, Central | Europe | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Clinic Activities | Program Activities | Programs | Organization and Administration | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Laboratory Examinations and Diagnoses | Psychological Factors | Behavior | Social Welfare | Economic Factors
Document Number: 329794  

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Title: Migraine: a question and answer review.
Author: Evans RW
Source: Medical Clinics of North America. 2009 Mar;93(2):245-62, vii.
Abstract: Internists commonly treat migraine, which affects more than 29 million Americans yearly. This article reviews epidemiology, pathophysiology, comorbidity, clinical features, diagnostic testing, acute and preventive treatment, and women's issues. Physicians and migraineurs would like to see more effective and more tolerable medications.
Language: English

Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | CLASSIFICATION | CELEBRITIES | PREVALENCE | MIGRAINE | SEX FACTORS | AGE FACTORS | GENETICS | COMPLICATIONS | EXAMINATIONS AND DIAGNOSES | SIGNS AND SYMPTOMS | HEADACHE | Developed Countries | North America | Americas | Research Methodology | Influentials | Knowledge Sources | Communication | Measurement | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Biology | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health
Document Number: 341118  

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Title: Effects of the contraceptive patch, the vaginal ring and an oral contraceptive on APC resistance and SHBG: a cross-over study.
Author: Fleischer K; van Vliet HA; Rosendaal FR; Rosing J; Tchaikovski S; Helmerhorst FM
Source: Thrombosis Research. 2009;123(3):429-35.
Abstract: INTRODUCTION: The transdermal patch (20 microg ethinylestradiol+150 microg norelgestromin daily) and the vaginal ring (15 microg ethinylestradiol+120 microg etonogestrel daily) are new contraceptives, designed to deliver a low dose of hormones, suggesting a low exposure. However, few data are available about their risk of venous thrombosis. The objective was to investigate the effect of the patch, the ring, and an oral contraceptive (30 microg ethinylestradiol+150 microg levonorgestrel daily) on activated protein C sensitivity ratio (APC-sr) and on sex hormone-binding globulin (SHBG) levels in plasma. MATERIALS AND METHODS: After a two month wash-out, 13 volunteers were randomly assigned to either the patch followed by the oral contraceptive or vice versa, or the ring followed by the oral contraceptive or vice versa. All treatments lasted two cycles and were separated by a wash-out of two cycles. APC-sr and SHBG levels were determined on day 18-21 of the second cycle of the wash-out and of each treatment period. RESULTS: Compared to the oral contraceptive, both the patch and the ring led to higher APC resistance (mean difference APC-sr 1.1; 95% CI 0.67-1.52 and 0.55; 95% CI 0.11-1.00, respectively) and higher SHBG levels (mean difference 210 nmol/l; 95% CI 134-286 and 148 nmol/l; 95% CI 48-248, respectively). CONCLUSION: The activity of the protein C system in plasma was impaired more by contraceptive patch and vaginal ring than by an oral contraceptive containing the second generation progestagen levonorgestrel.
Language: English

Keywords:
NETHERLANDS | RESEARCH REPORT | ETHINYL ESTRADIOL | VAGINAL RING | ORAL CONTRACEPTIVES | THROMBOSIS | RISK FACTORS | Europe, Western | Europe | Developed Countries | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health
Document Number: 330863  

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Title: Hematologic changes associated with zidovudine following single-drug substitution from stavudine in a home-based AIDS care program in rural Uganda.
Author: Forna F; Moore D; Mermin J; Brooks JT; Were W
Source: Journal of the International Association of Physicians in AIDS Care. 2009 Mar-Apr;8(2):128-138.
Abstract: Background. The authors evaluated hematologic changes associated with zidovudine (ZDV) following single-drug substitution from stavudine (D4T) in HIV-infected persons in Uganda. Methods. From May 2003 through February 2007, the authors evaluated incidence rates (IR) of hematologic abnormalities from quarterly blood draws among adults prescribed highly active antiretroviral therapy (HAART) before and after single-drug substitution of D4T to ZDV. Results. A total of 1089 adults received D4T-containing HAART (median observation time 35.9 months), and 290 (27%) had ZDV substituted for D4T. While taking D4T, IR for anemia was 0.35/100 person-months (PMs), leukopenia was 0.29/100PM, and thrombocytopenia was 0.32/100 PM. While taking ZDV, IR for anemia was 0.44/100 PM, leukopenia was 1.05/100 PM, and thrombocytopenia was 0.30/100 PM. Conclusions. Patients had a higher incidence of anemia and leukopenia after substitution from D4T to ZDV, but hematologic toxicity was not a major complication in this population. Patients on ZDV-containing HAART regimens are still at risk for anemia and need close monitoring.
Language: English

Keywords:
UGANDA | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | PERSONS LIVING WITH HIV/AIDS | ADULTS | RURAL POPULATION | HIV INFECTIONS | PREVALENCE | HOME CARE | ANTIRETROVIRAL THERAPY | HEMIC SYSTEM | SIDE EFFECTS | THROMBOSIS | ANEMIA | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | Measurement | Care and Support | Health Services | Delivery of Health Care | Health | HIV | Physiology | Biology | Treatment | Medical Procedures | Medicine | Thromboembolism | Embolism | Vascular Diseases
Document Number: 331335  

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Title: Spontaneous hepatic hemorrhage secondary to prolonged use of oral contraceptives.
Author: Jaffar R; Pechet L; Whalen GF; Banner BF
Source: Pathology, Research and Practice. 2009 Jul 3;
Abstract: Oral contraceptive pills (OCP) are the most commonly used form of contraception throughout the United States of America. The prolonged usage of oral contraceptives leads to a variety of complications, ranging from subclinical modifications of liver function tests to the development of benign and malignant tumors of the liver. Spontaneous hepatic hemorrhage secondary to oral contraceptive use was only reported once in the early 1980s. We report a case of spontaneous hepatic hemorrhage secondary to prolonged ingestion of combined OCPs followed by multiple pulmonary emboli without underlying thrombophilia.
Language: English

Keywords:
UNITED STATES OF AMERICA | SUMMARY REPORT | CASE HISTORIES | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | HEPATIC EFFECTS | BLEEDING | HEMATOMA | PULMONARY EMBOLISM | SURGERY | Developed Countries | North America | Americas | Data Collection | Research Methodology | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Physiology | Biology | Signs and Symptoms | Diseases | Embolism | Vascular Diseases
Document Number: 341974  

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Peer Reviewed

Title: Cyproterone acetate- and ethinyloestradiol-containing oral contraceptive as a risk factor for upper extremity deep venous thrombosis-a case report.
Author: Kapur R; Stramrood CA; Schutgens RE; van Asbeck BS
Source: European Journal of Contraception and Reproductive Health Care. 2009 Apr;14(2):160-3.
Abstract: Deep venous thrombosis of the upper extremity (UEDVT) is a rare variety of deep venous thrombosis. Compared to lower-extremity deep venous thrombosis, less is known about the risk factors for primary UEDVT. We report on a 27-year-old woman with UEDVT extending from the jugular and subclavian veins to the elbow. The thrombosis was possibly provoked by a shoulder trauma, in combination with heterozygosity for the prothrombin G20210A mutation and a protein S-deficiency, which may have been induced by the use of a cyproterone acetate- and ethinyloestradiol (CPA/EE)-containing oral contraceptive.
Language: English

Keywords:
NETHERLANDS | RESEARCH REPORT | CLINICAL RESEARCH | CASE STUDIES | WOMEN | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | THROMBOSIS | ACCIDENTS AND INJURIES | CHROMOSOME ABNORMALITIES | CYPROTERONE ACETATE | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE SAFETY | Europe, Western | Europe | Developed Countries | Research Methodology | Studies | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Thromboembolism | Embolism | Vascular Diseases | Diseases | Health | Neonatal Diseases and Abnormalities | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health
Document Number: 330935  

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Title: Acute Renal Vein Thrombosis, Oral Contraceptives, and Protein S Deficiency: A Successful Catheter-Directed Thrombolysis.
Author: Kim HK; Choi HH; Lee JM; Huh S
Source: Annals of Vascular Surgery. 2009 Jul 22;
Abstract: Acute renal vein thrombosis (RVT) is a rare but noteworthy form of venous thromboembolism. Traditional management has been systemic anticoagulation with heparin, followed by warfarin. We report a case of acute RVT with multiple pulmonary emboli that occurred in a 40-year-old woman who was taking oral contraceptives and was subsequently found to have protein S deficiency. The patient was treated with catheter-directed thrombolysis, and complete resolution of the RVT was achieved. This case suggests that oral contraceptive use in a patient with protein S deficiency may interact in a synergistic manner in the pathogenesis of thrombosis. Also, we believe that catheter-directed thrombolysis is warranted in selective cases in the absence of overriding contraindications.
Language: English

Keywords:
REPUBLIC OF KOREA | SUMMARY REPORT | CASE HISTORIES | CLIENTS | RENAL EFFECTS | THROMBOSIS | TREATMENT | ORAL CONTRACEPTIVES | SERUM PROTEIN EFFECTS | RISK FACTORS | BLOOD COAGULATION EFFECTS | Asia, Eastern | Asia | Developed Countries | Data Collection | Research Methodology | Program Activities | Programs | Organization and Administration | Urogenital Effects | Urogenital System | Physiology | Biology | Thromboembolism | Embolism | Vascular Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Hematological Effects | Hemic System
Document Number: 342328  

26.
Title: Hormonal contraception and risk of venous thromboembolism: national follow-up study.
Author: Lidegaard O; Lokkegaard E; Svendsen AL; Agger C
Source: BMJ. 2009;339:b2890.
Abstract: OBJECTIVE: To assess the risk of venous thrombosis in current users of different types of hormonal contraception, focusing on regimen, oestrogen dose, type of progestogen, and route of administration. DESIGN: National cohort study. SETTING: Denmark, 1995-2005. PARTICIPANTS: Danish women aged 15-49 with no history of cardiovascular or malignant disease. MAIN OUTCOME MEASURES: Adjusted rate ratios for all first time deep venous thrombosis, portal thrombosis, thrombosis of caval vein, thrombosis of renal vein, unspecified deep vein thrombosis, and pulmonary embolism during the study period. RESULTS: 10.4 million woman years were recorded, 3.3 million woman years in receipt of oral contraceptives. In total, 4213 venous thrombotic events were observed, 2045 in current users of oral contraceptives. The overall absolute risk of venous thrombosis per 10 000 woman years in non-users of oral contraceptives was 3.01 and in current users was 6.29. Compared with non-users of combined oral contraceptives the rate ratio of venous thrombembolism in current users decreased with duration of use (<1 year 4.17, 95% confidence interval 3.73 to 4.66, 1-4 years 2.98, 2.73 to 3.26, and >4 years 2.76, 2.53 to 3.02; P<0.001) and with decreasing dose of oestrogen. Compared with oral contraceptives containing levonorgestrel and with the same dose of oestrogen and length of use, the rate ratio for oral contraceptives with norethisterone was 0.98 (0.71 to 1.37), with norgestimate 1.19 (0.96 to 1.47), with desogestrel 1.82 (1.49 to 2.22), with gestodene 1.86 (1.59 to 2.18), with drospirenone 1.64 (1.27 to 2.10), and with cyproterone 1.88 (1.47 to 2.42). Compared with non-users of oral contraceptives, the rate ratio for venous thromboembolism in users of progestogen only oral contraceptives with levonorgestrel or norethisterone was 0.59 (0.33 to 1.03) or with 75 mug desogestrel was 1.12 (0.36 to 3.49), and for hormone releasing intrauterine devices was 0.90 (0.64 to 1.26). CONCLUSION: The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel. Progestogen only pills and hormone releasing intrauterine devices were not associated with any increased risk of venous thrombosis.
Language: English

Keywords:
DENMARK | RESEARCH REPORT | COHORT ANALYSIS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | THROMBOEMBOLISM | RISK FACTORS | THROMBOSIS | PULMONARY EMBOLISM | ESTROGENS | PROGESTATIONAL HORMONES | Developed Countries | Europe, Northern | Europe | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Embolism | Vascular Diseases | Diseases | Hormones | Endocrine System | Physiology | Biology
Document Number: 342468  

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Title: Yasmin and venous thromboembolism: new case reports.
Author: Lopez M; Vaya A; Martinez Triguero ML; Contreras MT; Todoli J; Ricart A; Laiz B
Source: Clinical Hemorheology and Microcirculation. 2009;42(1):65-9.
Abstract: It is not yet known whether Yasmin involves a higher thrombotic risk compared with other contraceptives. We present a serie of eight new cases of women who developed thrombotic events early after starting on Yasmin who were sent to our Thrombosis and Hemostasis Unit for a thrombophilia work-up in the last five years. Only two of them were heterozygous carriers of the prothrombin G20210A mutation and three were obese while none of them were smoker. These new cases provide information about the characteristics of the thrombotic events and the concomitant risk factors, indicating that this pill may not be as safe as had been previously thought, and suggest that new studies regarding safety profile of Yasmin are required to explain the association with venous thrombotic events.
Language: English

Keywords:
SPAIN | SUMMARY REPORT | CASE HISTORIES | CLIENTS | THROMBOEMBOLISM | RISK FACTORS | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE SAFETY | PULMONARY EMBOLISM | GENETICS | OBESITY | Developed Countries | Europe, Southwestern | Europe | Data Collection | Research Methodology | Program Activities | Programs | Organization and Administration | Embolism | Vascular Diseases | Diseases | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Biology | Body Weight | Physiology
Document Number: 342317  

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Title: Intrinsic clotting factors in dependency of age, sex, body mass index, and oral contraceptives: definition and risk of elevated clotting factor levels.
Author: Luxembourg B; Schmitt J; Humpich M; Glowatzki M; Seifried E; Lindhoff-Last E
Source: Blood Coagulation and Fibrinolysis. 2009 Jul 17;
Abstract: Elevated clotting factors have been demonstrated to be a risk factor for venous thromboembolism (VTE). The aim of our study was to investigate the impact of age, sex, body mass index, and oral contraceptives on the clotting factor activities of factors VIII, IX, XI, and XII and their impact on the cutoff definition and risk of VTE associated with elevated clotting factors. Factor VIII, IX, XI, and XII activities were measured in 499 blood donors and 286 patients with VTE. Age and body mass index predicted significantly and independently the clotting factor activities of factors VIII, IX, and XI, whereas use of oral contraceptives predicted factor IX, XI, and XII levels. Percentiles of clotting factor activities, which are often used for the cutoff definition of elevated clotting factors, varied due to the effect of age, body mass index, and oral contraceptives. The adjusted odds ratios for VTE were 10.3 [95% confidence interval (CI) 5.1-20.7], 6.1 (95% CI 3.1-12.0), and 3.3 (95% CI 1.9-5.8) for elevated factors VIII, IX, and XI, respectively. Furthermore, our study demonstrates for the first time that elevated factor XII is associated with an increased risk of VTE (adjusted odds ratio 2.9, 95% CI 1.6-5.3).
Language: English

Keywords:
GERMANY | RESEARCH REPORT | CLIENTS | BLOOD DONORS | AGE FACTORS | BODY WEIGHT | ORAL CONTRACEPTIVES | THROMBOEMBOLISM | RISK FACTORS | Europe, Central | Europe | Developed Countries | Program Activities | Programs | Organization and Administration | Blood Supply | Equipment and Supplies | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Characteristics | Demographic Factors | Population | Physiology | Biology | Contraceptive Methods | Contraception | Family Planning | Embolism | Vascular Diseases | Diseases
Document Number: 342216  

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Title: Counselling women about hormonal therapy.
Author: Martinelli I
Source: Thrombosis Research. 2009;123 Suppl 2:S74-8.
Abstract: Effective communication and counselling are critical for the successful use of oral contraceptives (OCs) and hormone replacement therapy (HRT). Effective communication requires listening and responding to patient concerns and then educating patients through personal interaction and materials that explain the risks and benefits of OC and HRT use. Where possible, actual data should be provided in terms that are easily understood by patients. The discussion of whether or not a woman should be tested for thrombophilia before using hormonal therapy should include the implications of thrombophilia testing for symptomatic and asymptomatic individuals. Pre-test counselling should include the potential advantages and disadvantages of hormone therapies and of thrombophilia testing, including the psychosocial aspects and implications for medical management. Clinicians should also clarify that thrombophilia testing is a matter of testing for a susceptibility gene rather than a disease state. Post-test counselling is equally as important for women who test both positive and negative. The goal of post-test counselling should be to help make decisions about hormone therapies. (excerpt)
Language: English

Keywords:
ITALY | CRITIQUE | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | WOMEN | COUNSELING | HORMONE REPLACEMENT THERAPY | THROMBOEMBOLISM | MENOPAUSE | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, SIDE EFFECTS | SIDE EFFECTS | PREVALENCE | AGE FACTORS | RISK FACTORS | Developed Countries | Europe, Southern | Europe | Research Methodology | Demographic Factors | Population | Clinic Activities | Program Activities | Programs | Organization and Administration | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Embolism | Vascular Diseases | Diseases | Reproduction | Safety | Public Health | Measurement | Population Characteristics
Document Number: 341122  

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Title: Pharmacotherapeutic options for the treatment of preeclampsia.
Author: McCoy S; Baldwin K
Source: American Journal of Health System Pharmacy. 2009 Feb 15;66:337-344.
Abstract: Purpose. Pharmacotherapeutic options for the treatment of preeclampsia are reviewed. Summary. Risk factors for the development of preeclampsia include microvascular diseases, such as diabetes mellitus; vascular and connective tissue disorders; hypertension; antiphospholipid antibody syndrome; and nephropathy. Several pathophysiological factors contribute to the development of the preeclamptic state, including vasospasm onset, coagulation system activation, increased inflammatory response, and ischemia. The specific agents used for the treatment of preeclampsia are dependent on a number of factors including symptom severity, maternal or fetal compromise, the progression to eclampsia, gestational period, and cervical status. The diagnosis of preeclampsia beyond the gestation period of 38 weeks requires delivery. The presence of maternal compromise or eclampsia at gestation greater than 20 weeks also necessitates delivery. In cases of chronic or mild hypertension, oral methyldopa may be administered on an outpatient basis. Intravenous hydralazine is a commonly administered arteriolar vasodilator that is effective for hypertensive emergencies associated with pregnancies. The most common adverse effect of hydralazine administration is unpredictable hypotension. Labetalol decreases heart rate and may be preferred because of a lack of reflex tachycardia, hypotension, or increased intracranial pressure. However, the drug of choice for the prevention and control of maternal seizures in patients with severe preeclampsia or eclampsia during the peripartum period is i.v. magnesium sulfate. Therapeutic serum magnesium levels cause cerebral vasodilation, thereby reversing the ischemia produced by cerebral vasospasm during an eclamptic episode. The results of one study indicated that women receiving magnesium sulfate therapy had a 58% lower risk of eclampsia than placebo. Conclusion. Magnesium sulfate remains the drug of choice for the prevention and treatment of preeclampsia. Alternative antihypertensive agents mayprovide additional benefit in the management of hypertension for preeclamptic patients.
Language: English

Keywords:
UNITED STATES OF AMERICA | RECOMMENDATIONS | PREECLAMPSIA | HYPERTENSION | RISK FACTORS | RENAL EFFECTS | SIGNS AND SYMPTOMS | DRUGS | ADMINISTRATION AND DOSAGE | SAFETY | LACTATION | PREVENTION AND CONTROL | Developed Countries | North America | Americas | Pregnancy Complications | Diseases | Vascular Diseases | Health | Urogenital Effects | Urogenital System | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Public Health | Maternal Physiology
Document Number: 340210  
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