Commercial production and distribution of contraceptives.
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Women with many medical conditions need to plan their families with special care. For such women, the risk of complications with particular contraceptive methods is increased. Women with severe hypertension, a previous myocardial infarction or venous thromboembolism, or cerebrovascular stroke have a significant risk of problems in pregnancy, and should avoid the combined pill. The combined pill may increase the risk of cardiovascular disease in patients with diabetes mellitus and may worsen the severity of migrainous headaches in susceptible patients. Women with active hepatitis should wait for liver function tests to normalise before becoming pregnant or starting the combined pill or injectable progestogen. Control of epilepsy may deteriorate with use of the combined pill; this is probably because of the risk of drug interactions. Similarly, contraceptive control may also fail in women receiving rifampicin (rifampin) concurrently with contraceptive steroids. Intrauterine contraceptive devices should not be used in women who have experienced previous episodes of pelvic inflammatory disease, or with previous malignancy of the genital tract until complete cure is likely. Other conditions which may appear, become more common or worsen when the combined pill is prescribed include hepatic adenoma, gall bladder disease, ulcerative colitis, alopecia, hirsutism and acne. Some of these conditions are potentially hazardous to the woman's health, in which case combined pill use should be stopped. If the condition is unchanged then the combined pill may sometimes be reintroduced with caution.
The increasing importance of an ectopic pregnancy as a cause of maternal death presents a challenge that will be met when primary care physicians combine a high index of suspicion with the ability to recognize the patient most at risk. The major symptoms, abdominal pain, secondary amenorrhea and abnormal vaginal bleeding are well known, as are the major signs, abdominal tenderness, adnexal mass and tenderness on motion of the cervix. Less well known are factors in the clinical history which indicate the patient to be at high risk. These include primary or secondary infertility, previous abortion or ectopic pregnancy and previous tubal operation, either reconstructive or sterilizing. In addition, the use of an intrauterine contraceptive device or its recent removal because of abdominal pain or bleeding, or both, is highly significant. Of major importance is a history of recent uterine evacuation. Should the diagnosis of ectopic pregnancy be under consideration, procrastination by observation is no longer acceptable. An active effort must be made to confirm or deny the diagnosis, Culdocentesis should be performed in the emergency department or clinic. If positive, prompt laparotomy is indicated. Should the result of culdocentesis be unsatisfactory or negative, laparotomy should be undertaken with further delay.
OBJECTIVE: To determine the vaginal flora of first time urban Family Planning clients at Korle-Bu Teaching Hospital and to assess its implications for the contraceptive choices made. DESIGN: A cross sectional study. METHODS: A standardized questionnaire surveying the sociodemographic characteristics and the choice of Family Planning method was administered to 100 clients at the Korle Bu Teaching Hospital between March and September 2001. High vaginal and endocervical swabs were also taken during the inspection of the vagina and cervix using a sterile bivalve speculum. The specimens were transported in Amies transport medium to the Microbiology laboratory for processing. RESULTS: The age range of the clients was 19-48 years with a modal age of 28 years. Ninety-six percent of them were married while 86% lived in urban slums. Sixty-three percent were sure of their last menstrual period. Potential pathogens were isolated from culture in 56% of the clients. Organisms causing bacterial vaginosis were the most prevalent in their genital tract. The intrauterine contraceptive device (IUCD) was the most common Family Planning method chosen, followed by the Norplant and the Depo-Provera injections. Potential pathogens were isolated from culture in 50% of those who chose the IUCD. CONCLUSION: Potential pathogens were isolated from culture in 56% of these first-time clients and organisms causing bacterial vaginosis were the most prevalent in the genital tract. It is suggested that Family Planning clients who screened positive for potential pathogens and opt for the IUCD should be considered for prophylactic antibiotics at insertion.
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A survey of 1500 students in post-secondary institutions in southwest Nigeria showed that the concept of emergency contraception (EC) was well known. Respectively, 32.4%, 20.4% and 19.8% knew that combined pills, progesterone only pills and intrauterine contraceptive device (IUCD) were usable for EC, while 56.7% mentioned the use of traditional methods. Only 11.8% had ever used either pills or IUCD and 10.7% had used a traditional method. Few students (11.5% and 2.3% respectively) knew the correct timing of EC pills and IUCD. The respondents reported varying circumstances under which EC was indicated but the majority cited condom breakage and sexual assault. The popular media represent the commonest source of information while hospitals/clinics were the commonest sources of procurement. About 37% of the respondents planned to use EC in future while 58% would not and 4.7% were uncertain. Reasons for these responses were explored.
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Vitamin A status measured by the relative dose response (RDR) test was determined among groups of Northern Thai women who had used estrogen-containing oral contraceptives (OCs) with or without multivitamin supplements through 13 cycles. Mean serum vitamin A values were elevated approximately 40% above those of control subjects (intrauterine contraceptive device (IUCD) users) during OC usage. Daily (one capsule) or periodic (two capsules 7 d/mo) multivitamin supplementation that included 1700 micrograms vitamin A per capsule did not significantly influence vitamin A serum values. The RDR test after 13 cycles was elevated in one individual who had taken OCs and the periodic multivitamin supplement. It reverted to normal after supplementation with vitamin A. A single high-dose vitamin A supplement (68,000 micrograms) did not change circulating levels of the vitamin. Among this population there is little evidence that use of estrogen-containing OCs for greater than 1 y resulted in a physiologically significant deterioration of vitamin A status.
Norplant, a sc contraceptive device, releases levonorgestrel in a sustained fashion. Its effectiveness is offset by irregular bleeding patterns. Because vascular endothelial growth factor (VEGF) is stimulated by synthetic progestogens in vitro and in vivo, we postulated that correlations between this angiogenic factor and uterine bleeding patterns might exist. Twenty-eight women who were exposed to Norplant and 13 control women were prospectively followed for 6-8 months. Bleeding diaries were collected, hysteroscopies were performed, endometrial biopsies were obtained for standardized histological evaluation, and VEGF histochemical immunostaining (H)-scores were assigned. Cluster determination-34 (CD34) staining was also performed to quantify the number of endometrial blood vessels per high-power field. Irregular uterine bleeding was common among women using Norplant devices. Endometrial VEGF H-scores were greater in women using Norplant than in control women. New findings of this study show that vessel density did not correlate with epithelial VEGF H-scores but was highly associated with the intensity of stromal and perivascular VEGF. VEGF expression in the latter regions correlated significantly with hysteroscopic abnormalities and irregular bleeding. The expression of this angiogenic protein, particularly in the stromal and perivascular compartments, correlated with microvascular density, hysteroscopically documented hypervascularity, and uterine bleeding profiles. Irregular bleeding with Norplant use appears to reflect paracrine-mediated effects on vascular function by angiogenic factors, such as VEGF.
A total of 200 Nigerian women visiting Nnamdi Azikiwe University Teaching Hospital's antenatal clinic were interviewed about their knowledge, attitude and practice of family planning. About 90% were literate. Their knowledge (80%) and approval (87%) of family planning was high, but the practice of modern family planning was low (25%) with most women involved in Billings/safe period (56%). The common methods used were Billings/safe period, condom, withdrawal and the intrauterine contraceptive device (IUCD). A total of 81.5% of the respondents are still willing to give birth while 77% agreed that their last pregnancy was planned. A total of 58.5% of respondents were educated about family planning in the antenatal clinic. The most common source of family planning information was mass media, closely followed by health workers, while the most common single reason for non-practice of family planning was rejection by the husband. We therefore conclude that despite the high education/literacy with the attendant and high knowledge and approval rate of family planning in this part of Nigeria, the practice of family planning is still low, especially due to partner objection. Policy makers should therefore increase male involvement in family planning programmes and pursue a more aggressive public awareness campaign.
The year 1979 marked the centennial of Margaret Sanger, birth control pioneer. Sanger worked to secure two new human rights: the right to decide whether to have a child and the right of a child to be wanted. Beginning in 1873, antipornography crusader Anthony Comstock lobbied through Congress and the state legislatures laws forbidding the distribution of contraceptive devices and even information. He equated these with erotic postcards as "obscene, lewd, lascivious, filthy, indecent and disgusting." Sanger's strategy was to challenge the Comstock laws in the courts. She studied birth control methods abroad and published a pamphlet, Family Limitation, in 1914. It was the first modern marriage manual; it was also illegal. The publicity her trial generated was immense and highly sympathetic. The government dropped its case when it saw it could only make her a martyr. An obstetrical nurse, Sanger had seen the plight of factory women in the poorest sections of New York City. In order to provide the medical advice and supplies women clamored for, Sanger opened the first U.S. birth control clinic, in Brooklyn in 1916. The New York City Vice Squad raided and closed it, and jailed Sanger. Margaret Sanger underwent other trials, raids, and harassments, but each time won additional public support for her organization--Planned Parenthood--and her cause.
High performance liquid chromatography was used to measure the concentrations of ethynylestradiol (EE) and levonorgestrel (LNG) released from contraceptive devices into aqueous medium containing the cationic detergent, benzalkonium chloride. Most of the detergent was removed after solvent extraction of the steroid, although small amounts of it remained in the steroid phase. Over the course of many injections into octasilyl (C8) or octadecylsilyl (C18) reversed-phase columns, the chromatographic profile of EE was gradually altered with multiple peaks emerging. The profile of LNG was not changed. EE chromatographed as a double peak on a fully end-capped C18 column. Rechromatography of each peak yielded a mixture of the two. Mass spectral analysis showed that the peaks differed only in the gain or loss of an equivalent of water. Introduction of a cation exchange column before the analytical column removed residual benzalkonium ions, and by thus preventing deterioration of the column, permitted EE to consistently emerge as a single, symmetrical peak.
Family planning centres can play a more extensive role than simple reproductive health, in particular for adolescents and young adults. They can become true health and counseling centres. In France, state supported family planning centres were officially created in 1972; they had been preceded by initiatives developed by non-profit associations. The centres have both educational and medical functions, in the areas of contraception and fight against sterility; since 1990 they have also integrated STD (sexually transmitted diseases) prevention and treatment into their mandates. Family planning centres offer free consultations to adolescent minors, without requiring adult authorization. Overall, young people under the age of 20 account for 25 to 40% of the family planning centre clientele, although they represent only 16% of the potential user population. Females are more likely to frequent the centres than males: one young women in 10 under 20 consults per year, as opposed to only one young man in 400. This is the case for 3 centres in the north of France, which were the objects of the study presented here. In the centres participating in the study, 80% of the clientele were under 20, with the vast majority being under 128 years of age. The availability of contraceptive devices has evidently reduced the reasons for frequenting the centres. As 1 youth in 4 is not yet sexually active however, the preventive role for these centres is obvious and well recognised by the young people. The study indicated that one adolescent among 17 frequents the centres for either health problems or counseling not necessarily having to do with sexuality; some go merely to find someone to talk to. Reasons for these choices most often cited are the assurance of confidentiality and lack of fees. The availability of counsellors, the possibility to consult alone or in a group the possibility to consult without an appointment, the quality of the reception, and the central location of the centres were also cited as important. What the young people appreciated in the family planning centres is exactly what they seek in general health service centres. It is not surprising, therefore, that they use the family planning centres as primary care structures.
Several transdermal contraceptive device (TCD) formulations were developed to provide a dual-controlled transdermal delivery of levonorgestrel (LN), a potent progestin, and 17 beta-estradiol (E2), a natural estrogen. Using a sensitive HPLC method, the in vitro release and skin permeation profiles of LN and E2 from various TCD formulations were simultaneously characterized in the hydrodynamically well-calibrated Valia-Chien skin permeation cells and both were found to follow zero-order kinetics. The rates of drug release and skin permeation were observed to vary significantly depending upon some formulation parameters. Six-month stability studies were performed on seven formulations at room and elevated temperatures (37 and 45 degrees C), and two (Formulations 4 and 5) were found to be acceptable, based on drug recovery, release rate, and skin permeation rate data. Judging from the 6-month accelerated stability studies, it is projected these two formulations will have shelf-life of at least 2 years. As a result of development of an efficient manufacturing process, Formulation 4 was selected for further evaluation. One-week primary skin irritation evaluation in 6 rabbits indicated that Formulation 4 is nonirritating, and it was thus selected for Phase I clinical bioavailability/dose proportionality studies in 12 healthy female volunteers of child-bearing age. Results of pharmacokinetic and pharmacodynamic analyses demonstrated that it is capable of achieving and maintaining a steady-state serum level of LN throughout the 3-week treatment period by weekly applications of one or two TCD patches (10 or 20 cm2). A dose proportionality was obtained in the serum drug levels, daily dose delivered, and contraception efficacy. An excellent correlation was obtained for the rates of transdermal delivery determined by the in vitro studies using human cadaver skin, the in vivo studies in rabbits, and the clinical studies in living subjects.
OBJECTIVE: To evaluate the ultrasound features of the endometrium and ovaries in women on etonogestrel implant, and to correlate these features with the bleeding pattern. METHODS: Observational study including 188 consecutive women presenting for follow-up transvaginal ultrasound examination after insertion of an etonogestrel implant contraceptive device. Thirty women had more than one follow-up examination. The bleeding pattern was considered abnormal if, in the last 3 months, there were more than five episodes of vaginal bleeding, or there was prolonged bleeding exceeding 14 consecutive days. RESULTS: At first follow-up examination, the mean age was 29.7 years and 47% of women had an abnormal bleeding pattern. Most bleeding episodes were of less intensity than menses. The mean endometrial thickness (ET) on ultrasound was 2.9 mm (standard deviation, 2.0). Ovarian follicle growth exceeding 5 mm was observed in 60% of the cases. Ovulation was demonstrated in one woman. Univariate analysis showed a positive association (P < 0.01) between ET, bleeding pattern, and bleeding intensity. Follicle growth was positively associated (P < 0.01) with ET, bleeding pattern, and interval between insertion and examination. Multivariate analysis showed that the ET was on average 1.25 mm greater in women with abnormal bleeding (P = 0.0001). The odds of finding follicle growth were 2.8 times higher (95% confidence interval, 1.2-6.2) in women presenting with a three-layer type of endometrial morphology. There was no association between the other patients' characteristics and the bleeding pattern. CONCLUSIONS: Abnormal uterine bleeding in women on etonogestrel implant was associated with follicle growth and a thicker, three-layer type of endometrium, suggesting incomplete ovarian inhibition and estrogen stimulation of the endometrium.
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