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A review of the use of progestogen-only minipills for contraception during lactation.

Progestogen-only minipills and other systems for releasing low doses of progestogens alone are widely used for contraception in breast-feeding women around the world. There is good evidence to confirm their acceptability and their lack of effect on milk production, neonatal growth and early development. In contrast, combined oral contraceptives frequently decrease milk production, and may produce minor changes in milk composition. However, even combined oral contraceptives do not appear to produce adverse effects on neonatal well-being and development, although minor reductions in initial growth rate may sometimes occur. Progestogen-only methods may also produce subtle changes in milk composition, although less than combined oral contraceptives. Steroids are transferred from plasma into milk in small quantities, but the amounts are usually very low or insufficient to allow detection in the infants using present-day assays. There has been theoretical concern that these tiny amounts of steroids might affect neonatal reproductive development, but this appears to be unwarranted. Progestogen-only methods are being widely used for post-partum contraception, and they appear to have particular advantages in this situation. They also have few disadvantages; a theoretical concern about a possible effect on later reproductive or sexual development has no evidence to support it. The present licensing situation in Australia, which lists lactation as a relative contraindication to progestogen-only contraceptive use, causes real concern to potential users and appears to lead to frequent errors in compliance.

Contraceptives, Oral, Hormonal↗

Oral contraceptives: a reassessment.

Cardiovascular risks attributable to oral contraceptive use may now be subdivided into those that appear to be secondary to the estrogen component, i.e., venous thrombosis, pulmonary embolism, and those linked to the progestin component, i.e., small vessel disease including myocardial infarction and cerebrovascular accident. It appears that venous risk is attributable to subtle changes in clotting factors, while arterial risk may be secondary to changes in glucose and lipid metabolism. In order to determine which women are at greatest risk from oral contraceptive use, Spellacy et al. has developed a risk scoring form that aids in the screening process. After excluding women with an absolute contraindication to pill use, women at greatest risk for cardiovascular disease related to oral contraceptive use are those with a family history of hyperlipidemia, gestational or overt diabetics, hypertensives, and smokers over the age of 35. The gradual reduction by manufacturers of the steroid content of oral contraceptives appears to have lessened the incidence of adverse effects. Our current knowledge of risk factors permits the clinician to reduce exposure to oral contraceptive-related mortality by as much as 86 per cent. As we continue to search for ways to reduce risk among oral contraceptive users, it is important to note that more than 25 per cent of women are still taking formulations containing 50 micrograms of estrogen. It becomes the responsibility of the practicing physician to "step-down" these patients to lower-dose preparations such as the multiphasics. Such preparations also represent optimal therapy for first-time pill users.

Contraceptives, Oral↗

Relationship between contraceptive method and vaginal flora.

This study was undertaken to assess whether the vaginal flora was affected by the method of contraception, and in particular as to whether the incidence of vaginal candidiasis increased when oral contraceptives were used. One thousand and two consecutive vaginal or cervical swabs from women attending a family planning centre were cultured. Candida albicans was isolated from 13% of women using no contraception, 16% using oral contraceptives, and from 9%, 19% and 18% of those using diaphragms, intrauterine contraceptive devices (IUCD) and condoms respectively. These differences were not statistically significant. Women using an IUCD had significantly more Gram-positive cocci cultured than women in any other group, while those using diaphragms had significantly more Gram-negative bacilli. Our clinical impression that the use of oral contraceptives led to an increase in vaginal candidiasis, was not confirmed by this study.

Candidiasis, Vulvovaginal↗

Effects of oral contraceptives on tryptophan metabolism and vitamin B6 requirements in women.

To evaluate the effect of oral contraceptive usage on the nutritional requirement for vitamin B6, control women and oral contraceptive users were depleted of vitamin B6 for 1 month followed by a month of repletion with 0.8, 2.0, or 20.0 mg of pyridoxine hydrochloride per day. At weekly intervals a number of indices of vitamin B6 nutrition were measured. Marked elevation in excretion of tryptophan metabolites occurred in oral contraceptive users after tryptophan loads. However, other indices of vitamin B6 nutritional state, including urinary 4-pyridoxic acid excretion, urinary cystathionine excretion, plasma pyridoxal phosphate concentrations, and erythrocyte aspartate and alanine aminotransferases were not different between controls and oral contraceptive users. The excretion of metabolites after oral loading doses of L-kynurenine (which bypasses tryptophan oxygenase) was elevated in oral contraceptive users indicating that abnormal metabolism of tryptophan was not due only to induced tryptophan oxygenase. The data indicate that use of oral contraceptives does not generally change the requirement for vitamin B6 but rather produces a specific change in activity of enzymes beyond kynurenine in the pathway of tryptophan metabolism.

Adult↗

[Vaginal and intrauterine contraception].

Vaginal contraception (condom, diaphragm and spermicide in pessary, tablet, jelly, cream, or sponge form) have been little used in France and generally in Europe since the advent of modern contraception with "the pill" and the intrauterine contraceptive device. The former methods, when properly used, are nevertheless both effective and useful, at least as interim measures. In addition, the protection they afford against sexually transmitted diseases and, for the condom, against HIV, is not negligible. Finally, the "barrier" methods of contraception such as the diaphragm and the condom afford significant protection against cancer of the cervix. The intrauterine contraceptive device (IUCD), used in France by 14% of women between 15 and 49 years of age and by 90 million women throughout the world for whom it is the main reversible means of contraception, have a mechanism of action that is still not fully understood. Most IUCD now used are made of copper. There are also diffusion IUCD based on progesterone or a synthetic progestational hormone which are useful in case of anaemia, menorrhagia or dysmenorrhea.

Administration, Intravaginal↗

Oral contraception and venous thromboembolism. A New Zealand perspective.

Several recent case control studies have shown an excess rate of venous thromboembolism in women using third generation progestogen-containing combined contraceptive pills compared to second generation combined contraceptive pills. This excess is about 1 in 10,000 women per year of use. It is likely that second and third generation pills have been preferentially prescribed to users who have varying susceptibility to venous thromboembolism and that this may account for at least part of the observed differences. In practice, it is essential that all women using combined oral contraceptive pills have a thorough history taken to exclude any contraindications or risk factors. Each client should be counselled about the risks and benefits of oral contraception. In New Zealand, the Ministry of Health has recommended that prescribers for women starting a contraceptive pill for the first time should consider a pill that does not contain a third generation progestogen. Women already receiving a third generation pill may elect to continue that pill after the differential rates of venous thromboembolism have been discussed.

Bias↗

Emergency contraception.

Emergency contraception is used after unprotected intercourse or a contraceptive accident to prevent unwanted pregnancy. It is thought to work by stopping or delaying ovulation or preventing implantation if fertilization has already taken place. Hormonal methods, mifepristone, and intrauterine device insertion are among the methods used worldwide. Combination estrogen-progestin birth control pills are the most commonly used form of emergency contraception in the United States. According to the Yuzpe method, combination pills are taken within 72 hours after intercourse, followed by a second identical dose 12 hours later. With this method, the number of unintended pregnancies is reduced by about 75%. Nausea and vomiting are the most troublesome adverse effects, but these can be controlled with antiemetic medication taken prior to the first dose. The Food and Drug Administration, Washington, DC, has approved an emergency contraception kit consisting of 4 combination pills, a urine pregnancy test, and a patient information book. Most recently, the Food and Drug Administration has approved a progestin-only formulation, which has fewer adverse effects and equal or improved efficacy compared with the combination formula. An intrauterine device can be inserted up to 5 days after unprotected intercourse and is a cost-effective option if it is used as ongoing contraceptive protection. The most readily available form of emergency contraception consists of 2 doses of estrogen-progestin combination birth control pills or 2 levonorgestrel pills taken 12 hours apart. Emergency contraception should not be considered as an alternative to ongoing contraceptive methods, but can prevent unwanted pregnancy.

Algorithms↗

Higher risk of venous thrombosis during early use of oral contraceptives in women with inherited clotting defects.

BACKGROUND: Results of recent studies show that the risk for venous thrombosis is highest during initial oral contraceptive use. This suggests a subgroup of females who are at immediate risk of thrombosis when exposed to oral contraceptives. OBJECTIVE: To determine whether women with inherited clotting defects who use oral contraceptives develop venous thrombosis at an earlier stage than do those without inherited clotting defects. METHODS: Analysis of the data from the Leiden Thrombophilia Study, a population-based case-control study with data on duration of oral contraceptive use and recently detected genetic coagulation disorders. Patients had a first episode of objectively proven deep vein thrombosis. Patients and controls were considered thrombophilic when they had protein C deficiency, protein S deficiency, antithrombin deficiency, factor V Leiden mutation, or prothrombin 20210 A mutation. RESULTS: Risk of developing deep vein thrombosis was greatest in the first 6 months and the first year of oral contraceptive use. Compared with prolonged use, the risk of developing deep vein thrombosis was 3-fold higher in the first 6 months of use (95% confidence interval [CI], 0.6-14.8) and 2-fold higher in the first year of use (95% CI, 0.6-6.1). Patients who developed venous thrombosis in the early periods of use were more often thrombophilic. Among women with thrombophilia, the risk of developing deep vein thrombosis during the first 6 months of oral contraceptive use (compared with prolonged use) was increased 19-fold (95% CI, 1.9-175.7), and in the first year of use, it was increased 11-fold (95% CI, 2.1-57.3). CONCLUSIONS: Women with inherited clotting defects who use oral contraceptives develop venous thrombosis not only more often but also sooner than do those without inherited clotting defects. Venous thrombosis in the first period of oral contraceptive use might indicate the presence of an inherited clotting defect.

Adolescent↗

Adolescent contraceptive use and parental notification.

Little research exists regarding the relationship between family communication and the sexual behavior and contraceptive use of adolescent females. A self-administered questionnaire was used to survey 196 adolescent females regarding communication with their parents about sexual issues and their reaction to proposed parental notification of the dispensing of prescription contraception. Parents of 80% of the subjects who were sexually experienced were aware of this activity. Parents of 80% of those subjects who had used contraception were aware of this use; 59% of these subjects informed their parents before their family planning visit. The majority of female adolescents (57%) were unwilling to communicate with their parents about sexual issues; 64% felt they should be able to receive prescription contraception without parental knowledge. Communication regarding sexual issues was related to lifetime contraceptive use. Eighteen percent of the sexually experienced subjects would not allow their parents to be notified of their family planning visit; 86% would use less effective contraception if family planning services were not sought. Our findings suggest that a parental notification policy will not compel all adolescents to inform parents about their contraceptive use; most adolescents will resort to less effective contraceptive methods.

Adolescent↗

Combined oral contraceptive pill (OCP) as treatment for primary dysmenorrhoea.

BACKGROUND: Dysmenorrhoea refers to the occurrence of painful menstrual cramps and is a common gynaecological complaint. Research as early as 1937 has shown that dysmenorrhoea responds favourably to ovulation inhibition, and that the synthetic hormones in the combined oral contraceptive pill can be used to treat dysmenorrhoea. These hormones act by suppressing ovulation and lessening the endometrial lining of the uterus. Therefore, menstrual fluid volume decreases along with the amount of prostaglandins produced, in turn effectively reducing dysmenorrhoea by decreasing uterine motility, and thus uterine cramping. The use of combined oral contraceptive pills (OCP) has been advocated as a treatment for primary dysmenorrhoea since their introduction for general use in 1960. There is evidence from epidemiological studies of general populations that combined OCPs can effectively treat dysmenorrhoea. OBJECTIVES: The objective of this review is to determine the efficacy of combined oral contraceptive pills for the treatment of primary dysmenorrhoea. SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials (RCTs) of the Cochrane Menstrual Disorders and Subfertility Group Register of controlled trials, CCTR, MEDLINE, EMBASE, and CINAHL, were performed. Attempts were also made to identify trials from the National Research Register, the Clinical Trials Register and the citation lists of review articles and included trials. SELECTION CRITERIA: The inclusion criteria were RCTs that compared all types of combined oral contraceptives (oestrogen/progestogen) with other combined oral contraceptives, placebo, no treatment, or treatment with nonsteriodal anti-inflammatory drugs (NSAIDs) in the treatment of primary dysmenorrhoea. The main outcome measures were pain relief, adverse effects, additional analgesics required and time off work or school. DATA COLLECTION AND ANALYSIS: Nine trials were identified that appeared to fulfil the initial criteria for this review. Of these nine trials, four were excluded, two at further investigation revealed a lack of randomisation and two included combined oral contraceptives that are now discontinued due to very high oestrogen content. Of the remaining five RCTs, four were included in the meta-analysis (Buttram 1969; Cullberg 1972; GPRG 1968; Nakano 1971). The results of the other trial (Matthews 1968) were included in the text of the review for discussion because data were not available in a form that allowed it to be combined in a meta-analysis. Data for all outcomes were in dichotomous form and the Peto odds ratio was used in the meta-analysis for all comparisons. MAIN RESULTS: Combined OCPs with medium dose oestrogen (>35 mcg) and 1st/2nd generation progestogens were shown to be more effective than placebo for pain relief. However, there was significant heterogeneity in the results from different studies and when data were analysed with a random effects model, the confidence intervals increased and the results became statistically non-significant. For the other outcomes, there was a significant difference in favour of OCPs when compared to placebo for the outcome of absence from work or school, and there was no difference between the treatment groups and placebo in the number of adverse effects experienced. REVIEWER'S CONCLUSIONS: No conclusions can be made about the efficacy of commonly used modern lower dose combined oral contraceptives for dysmenorrhoea. While there is some evidence from four RCTs that combined OCPs with medium dose oestrogen and 1st/2nd generation progestogens are more effective than placebo it should be emphasised that the studies were small, of poor quality and all included much higher doses of hormones that those commonly prescribed today. Therefore no recommendations can be made regarding the efficacy of modern combined oral contraceptives.

Contraceptives, Oral, Combined↗

Contraceptive practice after women have undergone "spontaneous" abortion in Indonesia and Sudan.

Studies of hospitalized "spontaneous" abortion patients in two Muslim countries (Indonesia and Sudan) revealed the need for contraception in this group of married women and indicated the potential role of maternity hospitals in providing them with contraceptive counseling. It could not be determined which of the abortions were induced outside the hospital and which were truly spontaneous. Of the 893 women treated at the Djakarta Hospital, 15.3% used contraceptives during the month of conception of the index abortion, compared to 10.0% of the 2 759 patients in Khartoum. After hospitalization for completion of the abortion, the rates of contraceptive use increased by more than one third in both cities. The highest rates of increase in contraceptive use after abortion were noted among poorly educated women, women with large families, and women with abortions diagnosed as septic. Among the nonseptic patients at all hospitals, those experiencing complications associated with the abortion reported a slightly higher rate of postabortion contraceptive use. In hospitals where contraceptive counseling was provided, there was a proportional increase in postabortion use of contraceptives by the study population.

Abortion, Induced↗

Oral contraceptive treatment inhibits the normal acquisition of bone mineral in skeletally immature young adult female monkeys.

The purpose of the present study was to determine the effects of oral contraceptive therapy on bone density and serum markers of bone metabolism in a prospective, longitudinal study of young adult female cynomolgus monkeys. Two hundred and seven intact cynomolgus monkeys were randomized to two groups, and fed an atherogenic diet containing either no drug (Control) or a triphasic oral contraceptive regimen (Contraceptive). Measurements of bone density were carried out by dual-energy X-ray absorptiometry at 10-month intervals (0, 10, and 20 months) and serum bone biomarkers were determined at 5-month intervals over the 20-month time course. No significant differences in these variables were observed prior to treatment. Both groups of animals gained bone mineral during the study, indicating that peak bone mass had not been reached at baseline. Contraceptive-treated animals gained less spinal (lumbar vertebrae 2-4) bone mineral content and density and less whole-body bone mineral content than Controls over the course of the study. Significant depressive effects of contraceptive treatment on gains in BMC and BMD were observed during each 10-month interval of the study. Bone metabolism was inhibited in the Contraceptive group, as reflected by marked reductions (approximately 40%) in serum osteocalcin and alkaline phosphatase levels along with moderate reductions in serum acid phosphatase and calcium. The results suggest that triphasic oral contraceptive treatment of young adult female monkeys that have not reached peak bone mass inhibits net bone accretion and/or growth by reducing bone metabolism. Thus, prolonged continuous oral contraceptive use in skeletally immature females may lead to a lower peak bone mass--an effect which could increase the risk of fractures in later life.

Absorptiometry, Photon↗

The association between body weight, unintended pregnancy resulting in a livebirth, and contraception at the time of conception.

OBJECTIVES: Annually, 3 million pregnancies in the United States are classified as unintended, with many of these unintended pregnancies occurring to women who use some type of contraceptive. Obesity may be affecting the biological effectiveness of contraceptives. We investigated whether there is an association between body weight and unintended pregnancy and whether this association differs by a woman's contraceptive status at the time of conception. METHODS: We conducted a case-control study using multistate data from the 1999 Pregnancy Risk Assessment Monitoring System. A total of 18,445 women provided complete information on pregnancy intention, contraceptive use at the time of conception, weight, height, and other covariates. Multivariable logistic regression was used to obtain odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Among contraceptors, overweight and obese women had nearly twice the odds of having an unintended pregnancy as compared to women with normal body mass indices (OR=1.73 [95% CI: 1.20, 2.36] and OR=1.75 [95% CI: 1.21, 2.52], respectively) after adjustment for age, marital status, education, socioeconomic status, Medicaid, race/ethnicity, and parity. No association was found between heavier weight and unintended pregnancy among noncontraceptors. CONCLUSIONS: Though the observed associations could be the result of selection bias or unmeasured confounding, the findings suggest that the effect of obesity on unintended pregnancy is limited to contraceptive failure. Prospective studies designed specifically to examine a body weight-contraceptive failure association are needed to determine if heavier women should be advised to use contraceptive methods other than hormonal contraceptives to prevent unintended pregnancy.

Adolescent↗

Effects of smoking and oral contraception on plasma beta-carotene levels in healthy women.

Oral contraceptive use and smoking have been known to affect plasma vitamin levels. Total carotenoids have been studied with spectrophotometry, a relatively insensitive technique. In this study plasma concentrations of beta-carotene and retinol were measured in coded samples by sensitive high-pressure liquid chromatography in a cross-sectional study of 149 normal healthy women attending a family planning clinic. At the time of recruitment in the morning, a general health questionnaire was administered for patient age, methods of contraception, smoking habits, and food intake at breakfast. Of the 149 enrolled volunteers, 88 were oral contraceptive users and 61 were not users. Among users, 21 smoked cigarettes, and there were 18 smokers among nonusers. Oral contraceptive users had significantly lower plasma concentrations of beta-carotene (p less than 0.001) and higher retinol levels (p less than 0.0001). Plasma beta-carotene or retinol levels did not differ among users of intrauterine contraceptive devices or barrier methods of contraception. No association was noted between the plasma levels of these two micronutrients and age greater than or less than 30 years. Cigarette smoking alone was associated with significantly reduced plasma beta-carotene levels in nonusers (p less than 0.001). Combined cigarette smoking and oral contraceptive usage were associated with low plasma beta-carotene levels; the results appear to be additive. These findings suggest a possible synergistic effect on plasma beta-carotene levels from the use of both cigarette smoking and oral contraception.

Adolescent↗

Cardiovascular risk status and oral contraceptive use: United States, 1976-1980.

Data from the second National Health and Nutrition Examination Survey, conducted in 1976-1980, were analyzed for the prevalence of cardiovascular risk factors (cigarette smoking, serum cholesterol, and blood pressure) among 2,342 premenopausal women ages 20-44 years, stratified by oral contraceptive use. For oral contraceptive users and non-users, adjusted means were serum cholesterol, 205 vs 188 mg/dl (P less than 0.05); systolic blood pressure, 116 vs 113 mm Hg (P less than 0.01); and diastolic blood pressure, 74 vs 73 mm Hg (NS). The prevalence of cigarette smoking was significantly higher among oral contraceptive users (44% compared with 36% among nonusers; P less than 0.05). Using the 1984 NIH Consensus Development Conference Statement on Lowering Blood Cholesterol to define risk levels for serum cholesterol, 23% of the oral contraceptive users were at high risk compared with 12% of the nonusers, and 16% of the oral contraceptive users vs 11% of the nonusers were at moderate risk. For users and nonusers, the respective prevalence of a blood pressure at or above 140/90 mm Hg was 5.3% vs 8.8% (unadjusted) and 8.6% vs 8.0% (age adjusted). The percentage of women with multiple risk factors was also higher among oral contraceptive user; 14% of the users had two or more risk factors vs 7% of the nonusers (P less than 0.05). These cross-sectional national data support data from clinical studies regarding the effect of oral contraceptives on cholesterol and blood pressure levels. In addition, since the use of oral contraceptives is widespread in the population and users tend to see physicians more regularly than other women, the data suggest that users of the pill are a good target group among which to screen and monitor cardiovascular risk factors.

Adult↗

Ambulatory blood pressure in mild hypertensive women taking oral contraceptives. A case-control study.

The aim of the present study was to compare the ambulatory blood pressure levels in mild (stage 1) hypertensive women using oral contraceptives and respective values in nonusers of oral contraceptives with similar office blood pressure. The study group consisted of 24 mild hypertensive patients taking low dosage estrogen-progestogen oral contraceptives. Seventy women of similar age and body mass index who had never used oral contraceptives served as a control group. Both daytime and nighttime systolic blood pressure values were significantly higher in oral contraceptive users. There was an average 8.3 mm Hg difference (95% confidence interval, 3.0 to 13.7 mm Hg; P = .003) for the daytime and 6.1 mm Hg difference (95% confidence interval, 0.4 to 11.8 mm Hg; P = .04) for the nighttime. No significant differences in ambulatory diastolic blood pressure between the two groups were found. These data provide evidence that hypertensive oral contraceptive users with the same office blood pressure as that in hypertensive noncontraceptive users have a significantly higher ambulatory systolic blood pressure. Our results support the opinion that alternative methods of contraception should be considered for hypertensive women in place of oral contraceptives.

Adolescent↗

Access to modern contraception.

Access to modern contraception has become a recognized human right, improving the health and well-being of women, families and societies worldwide. However, contraceptive access remains uneven. Irregular contraceptive supply, limited numbers of service delivery points and specific geographic, economic, informational, psychosocial and administrative barriers (including medical barriers) undermine access in many settings. Widening the range of providers enabled to offer contraception can improve contraceptive access, particularly where resources are most scarce. International efforts to remove medical barriers include the World Health Organization's Medical Eligibility Criteria. Based on the best available evidence, these criteria provide guidance for weighing the risks and benefits of contraceptive choice among women with specific clinical conditions. Clinical job aids can also improve access. More research is needed to further elucidate the pathways for expanding contraceptive access. Further progress in removing medical barriers will depend on systems for improving provider education and promoting evidence-based contraceptive service delivery.

Contraception↗

Costs and net health effects of contraceptive methods.

BACKGROUND: Pregnancy and contraceptive methods both have important health effects that include risks and benefits. The net impact of contraception on women's health has not been reported previously. STUDY DESIGN: This is a cost-utility analysis using a Markov model evaluated by Monte Carlo simulation using the societal perspective for costs. The analysis compared 13 methods of contraception to nonuse of contraception with respect to healthcare costs and quality-adjusted life years (QALYs). Discounting was applied for future costs and health effects. The base-case analysis applies to women of average health and fertility, ranging from 15 to 50 years of age, who are sexually active in a mutually monogamous relationship; smoking rates observed in women of reproductive age were used. Sensitivity analysis extended the analysis to nonmonogamous status and smoking status. RESULTS: Compared with use of no contraception, contraceptive methods of all types result in substantial cost savings over 2 years, ranging from US$5907 per woman for tubal sterilization to US$9936 for vasectomy and health gains ranging from 0.088 QALYs for diaphragm to 0.147 QALYs for depot medroxyprogesterone acetate. Compared with nonuse, even with a time horizon as short as 1 year, use of any method other than sterilization results in financial savings and health gains. Most of the financial savings and health gains were due to contraceptive effects. In a population of patients, even modest increases in the use of the most effective methods result in financial savings and health gains. CONCLUSIONS: Every method of contraception dominates nonuse in most clinical settings. Increasing the use of more effective methods even modestly at the expense of less effective methods will improve health and reduce costs. Methods that require action by the user less frequently than daily are both less costly and more effective than methods requiring action on a daily basis.

Adolescent↗