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Nonspermicide fit-free diaphragm trial reported.

The standard technique of diaphragm fitting and the use of spermicide with diaphragms have been challenged by Edward Stim, a physician who developed and tested a nonspermicide fitfree disphragm (NFFD) method. He suggested that the main cause of diaphragm failure was erratic use, and that occasional nonuse was a result of the irritations caused by overly large diaphragms, the messiness of spermicides, and the need to anticipate intercourse in order to place the diaphragm in advance. From 1974-79, Stim prescribed the Koroflex diaphragm with a rim diameter of 60 mm for all his patients requesting diaphragm contraception. He believed the 1 size produced "an efficient sperm-blocking obstruction in virtually all women." Stim deemphasized spermicide use while carefully instructing the women on correctdiaphragm placement and advising continual use of the device. He reported a high rate of effectiveness for a barrier method, with 1.1 pregnancies/100 woman-years of use. Failure rates ranging from 2-19% have been reported for users of conventional diaphragms with spermicide. In 1981, the Marie Stopes House in London undertook a study to determine the failure rate for the NFFD as compared to that reported for the conventional diaphragm, to ascertain acceptability of NFFD to women and their partners, and to determine whether NFFD offered significant practical advantages for service delivery. Family Health International assisted in the analysis of data. The incidence of pregnancy in the Marie Stopes study was much higher than had been previously reported. A total of 39 (35.5%) of the women remained in the study discontinued use of the NFFD within a 12-month period, 20 (18.2%) because they become pregnant. Of 110 women enrolled in the trial, 22 (20%) were lost to follow-up. The 2nd most common reason for termination of NFFD use was "personal reasons," including lack of confidence in the method. In spite of the reported pregnancy rate of 24.1/100 women at 12 months, a high level of acceptability of the NFFD was demonstrated among the women who had used it successfully. In fact, 48 (43.6%) women refused to discontinue use of the method even after being told of the high risk of pregnancy. Although the diaphragm is a proven contraceptive method, research remains to be done in this area. The NFFD study was not able to distinguish whether lack of fit or nonuse of spermicides caused the failures. A next step may be a small controlled trial of fitted diaphragms with and without spermicides.

Birth Rate↗

Are partners available for post-abortion contraceptive counseling? A pilot study in a Baltimore City clinic.

About half of the 1.2 million abortions each year in the United States are repeat abortions. While most abortion providers counsel women about contraception, one reason for the high repeat rate could be failure to take into account the social context of the women--in particular, the male partner. To assess whether there might be a window of opportunity for a contraceptive intervention that includes the male partner at the time of the abortion, we undertook a pilot study at an urban abortion clinic to examine the role of the male partner among women receiving abortions. Between May 2001 and August 2002, two questionnaires were administered to 109 women receiving abortions in a Baltimore City clinic. On the procedure day, women were more likely to be accompanied by a male partner upon arrival (30%) or when leaving (34%) than by any other individual. The majority of women receiving abortions reported that their partners played positive decision-making and support roles throughout the abortion process. A significant proportion of couples could be available for contraceptive counseling following an abortion, providing rationale for couples' post-abortion contraceptive counseling for women whose partners are already actively and positively involved in the abortion process. Such an intervention may help to reduce repeat abortions.

Abortion, Induced↗

Medical student awareness of sexual health is poor.

The aim of the study was to assess sexual health knowledge of medical students. Participants from the student population of an English Medical School (University of Bristol) were asked to fill in a questionnaire on the Internet about sexual health issues. The number of correct responses to each question was analysed according to participants' gender and medical school year. While certain issues relating to sexually transmitted infections, contraception and confidentiality in HIV testing were well understood, there was poor knowledge about the failure rate of condoms, abortion rates and prevalence of chlamydia. Women knew more about the contraceptive pill than men. Although increased years of medical training had some benefit in improving the accuracy of knowledge, this effect was surprisingly small. Most medical students have inaccurate factual knowledge about certain important sexual health issues. We consider this to reflect poorly on sexual health awareness in young people in general. There is need for greater sexual health education for future doctors and for the general public.

Attitude of Health Personnel↗

Condom failure among homosexual men.

Following a postal questionnaire survey of 262 homosexual men carried out to investigate condom use during sexual activity, a sample of 97 men who used condoms during anogenital sex was identified. Thirty-one percent of those who had used a condom during anal intercourse reported at least one incident of condom breakage. When looked at in terms of frequency of individual condom use, it was found that 1 in 27 condoms break during this activity. Examination of the reasons for breakage and a review of the literature indicated that physical stress on the condom is likely to be a major factor in these incidents.

Adult↗

Hormone replacement therapy in perimenopausal women with a low dose oral contraceptive preparation: effects on bone mineral density and metabolism.

In a 2-year longitudinal, calcium-controlled study we evaluated bone density and metabolism in perimenopausal women with initial ovarian failure, and the effects of hormone replacement with a low dose oral contraceptive preparation (OC). In perimenopausal oligomenorrhoic women (n = 16) a significant (P < 0.01) increase in cycle length and plasma FSH levels as well as a parallel decrease in plasma estradiol levels (P < 0.01) were evident. In this group, despite the calcium supplementation (500 mg/day), a significant (P < 0.001) increase in the biochemical markers of bone remodelling paralleled a significant (P < 0.001) decrease (-3.4% after 24 months) in bone density. Conversely, in premenopausal oligomenorrhoic women treated with a low dose oral contraceptive (OC) formulation (30 mcg ethinyl estradiol plus 75 mcg gestodene, n = 16), bone markers showed a significant (P < 0.01) decrease, that paralleled a slight but significant (P < 0.01) increase (+1.71%) in bone density. These data suggest that premenopausal administration of OC can prevent the acceleration of bone turnover and reverse the decrease in bone density that follows the premenopausal impairment of ovarian function.

Administration, Oral↗

Effects of oral and intrauterine administration of contraceptives on the uterus.

Combined regimen contraceptive steroids produce precocious endometrial secretion, followed by involution leading to a suppressed endometrium with small tubular glands and failure of spiral arterioles to develop; decidua-like stromal changes are dose related as is dilatation of venules. Thrombosis of the latter, perhaps estrogen mediated, leads to local tissue infarction and is the proximate cause of "breakthrough bleeding". Sequential regimen contraceptive steroids lead to retarded endometrial secretion, failure of spiral arterioles to develop, and a weak decidua-like stromal transformation. Contraceptive steroids occasionally produce polypoid lesions of the endocervix with atypical microglandular hyperplasia. There are conflicting reports about the effects of contraceptive steroids on the squamous epithelium of the exocervix, but they neither protect against cancer nor cause it in the usually accepted sense. Uterine leiomyomas may exhibit increased cellularity and bizarre, hyperchromatic nuclei or mutinucleation in women receiving contraceptive steroids. Both polyethylene and metal-containing intrauterine devices may initiate inflammatory responses in the endometrium varying from mild to severe, related to the time the device has been in contact with the mucosa. Salpingitis and ectopic pregnancy are increased in frequency in device users.

Adult↗

[Family planning: a need in primary care].

The reformation of Primary Care (PC) permits a more satisfactory and coordinated approach to family planning (FP). We evaluated the profile of the potential users of FP by means of a survey of 182 females made in a Primary Care center (CAP). The most commonly used contraceptive methods were oral contraceptives (20.3%), coitus interruptus (Cl) (18%), condom (17%) and female sterilization (12.6%). 66.6% of failures were attributed to Cl. 32.25% of the intrauterine device users and 24.4% of those taking oral contraceptives reported problems. 24.7% of females were controlled in the CAP II, 19.7% by their private gynecologist, 16.5% in the municipal CP and 6% in the CAP. 30.2% of the users did not follow and type of control.

Adolescent↗

[Emergency contraception with levonorgestrel for teenagers--efficacy, tolerability, and level of information awareness].

OBJECTIVE: Assessment of efficacy and side effects of emergency contraception for teenagers with levonorgestrel (LNG) and the level of users' informedness about possibilities and practical application. METHODS: The subjects are healthy girls (n = 49) with regular menstrual cycles at the age between 15 and 19, having had one unprotected or faultily protected sexual intercourse. All of them have administered 0.75 mg LNG within the 72nd hour, repeated after 12 hours. The data have been processed by variational analysis. RESULTS: One pregnancy was registered of a girl with firstintake at the 67th hour - pregnancy rate - 2,0%. The most frequent side effect was nausea - 26,5%, folowed by breast tenderness - 22,4% and fatigue - 20,4%. An up to 7th day delay in menstrual cycle is non significantly more frequent - 14,3%, followed by a delay of more than 7 days breakthrough bleeding - 8,2%. No significant changes were established in the lenght of the menstrual cycle. Emergency contraception is sought for after unprotected sexual intercourse in 69,4%, and condom failure problems in 30,6%. Only 18,4% have sufficient information about the possibilities and practical use of emergency contraception. CONCLUSION: LNG provides effective, highly tolerable contraception with a small number of side effects. Need is felt for serious popularization of the application of emergency contraception with teenagers.

Adolescent↗

Intention to use contraceptives and subsequent contraceptive behavior in Morocco.

In this article, the relationship between stated intention to use contraceptives and subsequent use during a three-year period in Morocco is examined. Longitudinal data are drawn from two Demographic and Health Surveys: the 1992 Morocco DHS and the 1995 Morocco Panel Survey. Reported contraceptive intentions in 1992 have a strong predictive effect on subsequent contraceptive use even after controlling for other characteristics of respondents, and the strength of the effect is second only to that of previous contraceptive use. Women who in 1992 said they intended to use contraceptives in the future but did not do so are the most likely to have had an unmet need for contraception in 1995. Weakly held fertility preferences reported by some of the women surveyed in 1992 appear to have been a contributing factor in the subsequent failure of these women to act upon their intention to practice contraception.

Adolescent↗

[Renal thrombotic microangiopathy with benign hypertension and uremia secondary to oral contraceptives (author's transl)].

A 34-year-old woman developed uremia secondary to severe renal thrombotic microangiopathy after 3 years intake of oral contraceptives. In this particular case manifestation of end stage renal failure was preceded by an unusually long lasting period of nine months with benign hypertension. Even during the final stage (3-4 weeks) prior to complete development of uremia only once hemolysis but no malignant hypertension was observed. Only close long term follow up including renal biopsy and subtile functional tests may provide information whether and/or when hypertension due to oral contraceptives turns to become--at least in part--renal hypertension and also becomes persistent. This observation does not give evidence that benign hypertension causes renovascular damage and thus renal failure. Plasma renin activity was found to be basically elevated and furthermore stimulated e.g. by dialyses. However, this single observation does not permit any conclusion about a pathogenetic role of renin in creating hypertension by e.g. renal vasoconstriction or--despite hypertension--collapse of the capillary network.

Adult↗

Some clues and pitfalls in the diagnosis of acromegaly.

OBJECTIVE: To describe a case of acromegaly in a young woman using oral contraceptives who had nonspecific symptoms and persistent hyperphosphatemia and to analyze the reasons for delay in diagnosis. METHODS: A 31-year-old woman underwent evaluation for failure of menstrual flow to resume after discontinued use of oral contraceptives. Clinical and laboratory findings are summarized, and atypical manifestations of acromegaly are discussed. RESULTS: The patient complained of weight gain, acne, and increased facial hair growth, and laboratory tests showed a low estradiol level and hyperinsulinemia. "Post-pill amenorrhea" and polycystic ovary syndrome were considered possible diagnoses. During subsequent endocrinology consultation, hyperphosphatemia was present on three occasions during a 7-month period. Hormonal studies for evaluation of pituitary function revealed increased insulin-like growth factor-I and growth hormone (GH) levels. Acromegaly was suspected, and the increased GH level failed to suppress after a glucose load. Magnetic resonance imaging revealed a pituitary macro-adenoma with suprasellar extension. Visual field testing showed bitemporal abnormalities. Transsphenoidal resection successfully removed the GH-producing tumor, and hormone replacement therapy was initiated postoperatively. CONCLUSION: The textbook presentation of GH excess is a late feature of acromegaly. The diagnosis in a young woman can be easily missed when clinicopathologic findings are not classic and the picture is further clouded by factors such as oral contraceptive use. Features may also resemble polycystic ovary syndrome, a more common condition in women of childbearing age. This case also illustrates that hyperphosphatemia, overlooked in this patient, can precede the full-blown clinical manifestations of acromegaly and serve as a subtle clue to the underlying disease. Awareness of these situations and screening for high GH levels in patients with unexplained, persistent hyperphosphatemia are advisable for making an early correct diagnosis and providing appropriate therapy.

Acromegaly↗

GyneFIX. The frameless intrauterine contraceptive implant--an update for interval, emergency and postabortal contraception.

This article reviews the clinical experience with the GyneFix intrauterine implant system for interval, emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women. The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnacies and induced abortions.

Abortion, Induced↗

Osteoporosis in anorexia nervosa: the influence of peak bone density, bone loss, oral contraceptive use, and exercise.

Anorexia nervosa occurs early in life and predisposes to osteoporosis. Exercise may be protective. We asked: (1) Does failure to attain peak bone density contribute to the deficit in bone density? (2) Does oral contraceptive use protect against osteoporosis? (3) Is any protective effect of exercise confined to weight-bearing sites? Areal bone density (g/cm2) and body composition were measured by dual x-ray absorptiometry in 65 patients with anorexia nervosa and 52 controls. Comparing the 12 patients with primary amenorrhea and the 37 patients with secondary amenorrhea, bone density (mean +/- SEM) at the lumbar spine was 0.88 +/- 0.04 versus 1.06 +/- 0.03 (P = 0.001), respectively. Bone density at the femoral neck was 0.80 +/- 0.04 versus 0.92 +/- 0.03 (P < 0.05), respectively. These values differed before, but not after, adjusting for the respective duration of illness (73.0 +/- 10.3 versus 34.1 +/- 4.8 months, P < 0.001) and fat-free mass (31.6 +/- 1.3 versus 35.4 +/- 0.5 kg, P < 0.01). Bone density at the lumbar spine in the 16 patients with 31.8 +/- 8.3 months of contraceptive exposure was higher than in the 49 patients with no contraceptive exposure (1.14 +/- 0.05 versus 1.02 +/- 0.02 P < 0.02) but was lower than in controls (1.14 +/- 0.05 versus 1.27 +/- 1.02, P < 0.01). No protective effect of contraceptive exposure was detectable at the femoral neck.(ABSTRACT TRUNCATED AT 250 WORDS)

Absorptiometry, Photon↗

Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic↗

Norplant implants in Ethiopia.

This is a cross-sectional study involving 364 clients who have had Norplant implants insertion for contraception at the Gandhi Memorial Hospital (GMH) during the second half of 1994. It was part of the pilot project designed to introduce Norplant in Ethiopia after evaluating the safety, efficacy, tolerance, acceptability and reversibility of the method. The vast majority of the clients were found to be married, housewives, multiparae, relatively educated, urban dwellers, Christian by faith and in their reproductive age group with a mean age of 27.9 +/- 5.7 years. A significant number of them used one or more types of contraceptive methods prior to their switch to Norplant (P < 0.05). A third of the patients were lactating at the time of the Norplant insertion. The time taken to insert the implants was 12.5 +/- 4.3 minutes. The mean duration since the insertion is computed to be 25.3 +/- 4.2 months. Their main source of information was from the medical personnel. The acceptability and continuation rate of the method was 93.9% and 95.1%, respectively. The fertility-reversibility among those who desired to have childbirth was achieved in 72.3% and 84.1% at one and two years, respectively. Adverse effects of Norplant were registered in a quarter of the study population and included abnormal menstruation, headache, weight changes and pain at the site of implantation. These were not influenced by age, body weight, parity, duration of usage of the method, blood pressure patterns and previous use of contraception (P > 0.05). We have not encountered any method failure in the last 30 months. The study concludes that Norplant is safe, effective, acceptable, and reversible long-term birth control method which can be used in our setting in parallel with other available options.

Adolescent↗

A randomized, double-blind study of two combined oral contraceptives containing the same progestogen, but different estrogens. World Health Organization Task Force on Oral Contraception.

The results are reported of a randomized, double-blind study of two daily oral contraceptives, both containing 3mg norethisterone acetate; one also contained 50 microgram ethinyl estradiol, while the other contained a mixture of micronized 4mg estradiol plus 2mg estriol. The trial was conducted to a common protocol at WHO Collaborating Centres for Clinical Research (CCCR's) in Bangkok, Bombay, Singapore and Szeged. Of the 925 women who entered the study, 458 received the product containing "natural" estrogens and 467 received the product containing ethinyl estradiol. Analysis of admission characteristics showed that the two groups were very closely matched. There was no statistically significant difference in contraceptive efficacy between the two products; both have annual failure rates of approximately 1 per 100 women. The discontinuation rate after one year was 51.5 for the "natural" estrogen product and 48.4 for the one containing synthetic estrogen. Discontinuation for menstrual irregularities was significantly higher for the "natural" estrogen preparation. During both the first three treatment cycles and the tenth to twelfth cycles, the incidence of various menstrual irregularities was significantly higher in the "natural" estrogen contraceptive. Adverse clinical associations were those commonly reported with other combined oral contraceptives for both preparations. It is concluded that the high incidence of menstrual irregularities associated with the particular combination of norethisterone acetate and "natural" estrogens renders it less suitable for general use in family planning programmes than combinations containing synthetic estrogens, such as ethinyl estradiol.

Adolescent↗

Contraception in the puerperium.

Choice of contraception in the puerperium is complicated by the normal factors of lactation, involuting uterus and emotional lability. The individual's previous contraceptive experience is important, and new agents and techniques change current practices. In the puerperium, failure for IUDs is increased, and tubal ligation has more hazards. During lactation the standard combined oral contraceptives are not advised, but the microdose progestagen-only pill may be a most satisfactory agent-changing to more routine methods when menstruation starts. In a population of normal women, progestagen-only therapy may show about a 25 per cent dropout because of an unacceptable bleeding pattern, but there is a small group of women who appear to be well suited by this form of oral contraception.

Contraception↗

Diode laser assisted transcervical tubal sterilization: an in vivo study in rabbits.

BACKGROUND AND OBJECTIVE: To investigate the sterilization effectiveness of endoluminal tubal photocoagulation on tubal lumen obliteration. STUDY DESIGN/MATERIALS AND METHODS: Twenty-four female rabbits were subjected to laparotomy and hysterotomy. Endoluminal tubal photocoagulation was induced over a length of 3 cm in the proximal, extramural fallopian tube by using a cylindrical diffusing tip that emitted diode laser radiation at 805 and 980 nm wavelengths. Tubal patency was evaluated by observing patterns of injected methylene blue and/or breeding success rates. RESULTS: Postoperative recovery was uneventful in all animals. Evidence of occlusion of the tubal lumen included a negative methylene blue test in all 12 tubes treated (tubal occlusion rate 100%) and failure to conceive in 17 of 18 uteri (contraception rate 94.5%). Although identical power settings were used, distinctly lower tubal surface temperatures (about 10 degrees C) were obtained with the 805 nm diode laser as compared to the 980 nm diode laser. CONCLUSIONS: The described endoluminal tubal photocoagulation method using a diode laser emitting longer wavelengths (e.g., 980 nm) is suitable for safe and effective sterilization in rabbits and has potential as a new transcervical tubal sterilization method for humans.

Animals↗