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States' implementation of the Section 510 abstinence education program, FY 1999.

CONTEXT: As part of its reworking of the nation's welfare system in 1996, Congress enacted a major new abstinence education initiative (Section 510 of Title V of the Social Security Act), projected to spend $87.5 million in federal, state and local funds per year for five years. The new program is designed to emphasize abstinence from sexual activity outside of marriage, at any age, rather than premarital abstinence for adolescents, which was typical of earlier efforts. The actual message and impact of the program, however, will depend on how it is implemented. METHODS: Program coordinators in all 50 states, the District of Columbia and Puerto Rico were surveyed concerning implementation of the Section 510 abstinence education program in FY 1999. The questionnaire asked about expenditures and activities performed, about policies established for a variety of specific situations and about how the term "sexual activity" is defined and what specific components of the federal definition of "abstinence education" are emphasized. RESULTS: Forty-five jurisdictions spent a total of $69 million through the Section 510 program in FY 1999. Of this total, $33 million was spent through public entities, $28 million was spent through private entities and $7million (in 22 jurisdictions) was spent through faith-based entities. Almost all jurisdictions reported funding school-related activities, with 38 reporting in-school instruction and presentations. Twenty-eight jurisdictions prohibited organizations from providing information about contraception (aside from failure rates), even at a client's request, while only six jurisdictions prohibited information about sexually transmitted diseases. Few reported having a policy or rendering guidance about providing services addressing sexual abuse, sexual orientation or existing pregnancy and parenthood. Only six respondents said they defined "sexual activity" for purposes of the program, and 16 reported focusing on specific portions of the federal definition of "abstinence education." CONCLUSIONS: More than one in 10 Section 510 dollars were spent through faith-based entities. Programs commonly conducted in-school activities, particularly instruction and presentations, not only through public entities, but also through private and faith-based entities. Most jurisdictions prohibited the provision of information about contraception, about providers of contraceptive services or about both topics, even in response to a direct question and when using other sources of funding. Most also left definitions of "abstinence" and "sexual activity" as local decisions, thus not clearly articulating what the program is designed to encourage clients to abstain from.

Adolescent↗

[No reduced number of abortions despite easily available emergency contraceptive pills. Studies of women's knowledge, attitudes and experience of the method].

Despite the fact that emergency contraceptive pills (ECP) have become easily available across the country during recent years, abortion numbers continue to rise in Sweden, especially in the young age groups (< 25). In a series of studies, we have investigated knowledge, attitudes and experience of ECP among young women. Our results show that, whereas most women are aware of the method, many lack knowledge about the mechanism of action and time frames for best use, which could explain why ECPs are not used by more than a fraction of women who might have had benefit from their use. Since half of the women requesting a termination of pregnancy stated that they would have used ECP if they had had them available at home at the time of the unprotected intercourse which led to an unintended pregnancy, it seems reasonable to encourage women to keep ECPs at home, in case the need should arise. It is important that ECPs are available without prescription, but beyond that, much more information about ECP is necessary in order for the method to be widely accepted and used as a back-up after failure with other contraceptives.

Abortion, Legal↗

The emergency contraception collaborative prescribing experience in Washington State.

OBJECTIVE: To describe how prescribers and pharmacists view the Emergency Contraceptive Pills (ECP) program, and to evaluate pharmacists' performance through the use of a consumer survey. DESIGN: Self-administered provider satisfaction surveys were mailed 6 months after the program's inception. Consumer satisfaction surveys were distributed at the point of ECP service for return by mail. SETTING: The program encouraged pharmacists and prescribers in western Washington to enter into collaborative prescribing agreements, increasing consumers' access to ECP. PATIENTS OR OTHER PARTICIPANTS: Pharmacists who had attended ECP training sessions, prescribers who had authorized pharmacists to prescribe ECP, and women who had been prescribed ECP by pharmacists. MAIN OUTCOME MEASURES: Providers' reasons for participating, attitudes toward the ECP program, and experiences with ECP as a result of the program; feedback from women receiving ECP from pharmacists. RESULTS: 309 pharmacist surveys and 55 prescriber surveys were sent, of which 159 (51%) and 27 (49%), respectively, were returned. Meeting patient needs and having a professional responsibility to participate were commonly reported reasons for ECP program involvement. Both pharmacists and prescribers (92%) reported being "satisfied" or "very satisfied" with their prescribing agreements. On the 470 consumer surveys returned out of 7,000 distributed (6.5%), pharmacists were rated highly satisfactory for their interactions with patients and the quality of information about ECP use given, but less satisfactory for information about adverse effects, recognition and follow-up of ECP failure, and regular contraceptive methods. CONCLUSION: All participants expressed satisfaction with the ECP program. This example should support the initiation of similar programs in other states.

Adult↗

Contraceptive discontinuation among married women in the United States.

Using data from the 1982 National Survey of Family Growth (NSFG), this analysis reports differentials in contraceptive discontinuation among married women aged 15-44 years in the United States. The total discontinuation rate is broken down into change to no method (termination) or to a different method (a method switch), and rates are obtained for specific methods. In addition, sociodemographic differences in risks associated with each type of discontinuation are shown. Discontinuation rates are compared to use-failure rates to provide a more comprehensive understanding of the implications of discontinuation for contraceptive efficacy.

Actuarial Analysis↗

An overview of oral contraceptives: mechanism of action and clinical use.

Hormonal contraception is available in oral contraceptive pills and in newer formulations, including the transdermal patch, the vaginal ring, subcutaneous implants, and IM injections. Prevention of pregnancy is achieved by inhibiting ovulation, fertilization, and/or implantation of an egg. Hormonal contraception provides effective, tolerable, and reversible prevention of pregnancy. Efficacy and safety profiles are similar for different formulations and administration routes. Lowest expected failure (i.e., method failure) rates for hormonal contraceptives, regardless of formulation, are <2%. Typical failure rates for oral formulations range from <3% to 5% due to failures in compliance. The most commonly reported adverse effects are weight gain, nausea, variations in menstrual flow, breast changes such as tenderness, discomfort, or swelling, depression or mood disturbances, decreased sexual desire or response, and acne. Rare but serious potential effects include cardiovascular diseases, such as stroke, and an increased risk for breast cancer, liver tumors, and gallbladder disease. Hormonal contraceptive use should be avoided in women at risk for blood clots, by heavy smokers, and in women with breast or other cancers. Use of hormonal contraception in adolescents requires special consideration, in part because of decreased compliance.

Adolescent↗

Patient counseling.

The success or failure of oral contraceptive (OC) use depends very heavily on the type and extent of the counseling a woman is given both before and during pill administration. If she selects the OC as her method of choice after considering all the options, a clear, detailed, and accurate discussion should ensue about its proper use; any fears that she may have should be explored; and great emphasis should be placed on the advantages and effectiveness of our current pills and, above all, on their numerous health benefits. All her questions should be answered in a thorough and emphatic fashion, and she should be encouraged to ask for additional answers at any time in the future. Finally, if her history reveals that she is at risk for sexually transmitted diseases (STDs), she must be informed that the pill, while highly protective against unplanned pregnancy, will not provide protection against most STDs or HIV infections, and that she should also use condoms and/or a female barrier contraceptive with each act of intercourse.

Communication↗

Innocuity of tetradecyl-dimethyl-benzyl ammonium fluoride on the DNA of human spermatozoa.

Tetradecyl-dimethyl-benzyl-ammonium fluoride (TDBAF) is a powerful new spermicide. In cases of failure of local contraception, there is a theoretical risk that a spermatozoon exposed to a sublethal concentration of spermicide might suffer DNA strand breaks, with transmission of damaged DNA to the oocyte. The present study aims to ascertain the innocuity of TDBAF in this regard. Spermatozoa from 32 fertile men were exposed to a sublethal concentration of TDBAF. The degree of DNA fragmentation was measured by modified terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin end labeling (TUNEL) assay, pulsed field gel electrophoresis of purified sperm DNA and radioenzymatic labeling. With the TUNEL assay, a statistically significant increase in sperm labeling was observed after TDBAF treatment compared to the controls. However, pulsed field gel electrophoresis and enzymatic labeling of purified DNA showed no evidence of augmented DNA fragmentation in TDBAF-treated sperm. Under electron microscopy, TDBAF caused sperm chromatin decondensation. In the TUNEL assay, this phenomenon would allow easier access of terminal transferase to its DNA substrate, explaining the apparent increase in DNA fragmentation in the presence of TDBAF. In conclusion, the use of TDBAF as a spermicide does not place progeny at heightened risk of abnormalities should pregnancy occur. In regard to the TUNEL assay, we suggest that pretreatment of spermatozoa with TDBAF promotes a more accurate measurement of sperm DNA fragmentation.

Adult↗

Use of psychotropic drugs and pregnancy outcome.

This study reports the use of psychotropic drugs and pregnancy outcome in a prospective survey carried out in northern Finland in 1985-1986, consisting of 7933 pregnant women and their 8030 births. Of the mothers, 120 (1.5%) used psychotropic drugs during pregnancy and of them 26 (0.3% of the total) used these drugs before and during the pregnancy. According to the logistic regression analysis, the biological and social background variables associating significantly with the use of these drugs were maternal advanced age and multiparity (> 35 years and > 4 parous), overweight (body mass index > the 90th percentile), smoking, alcohol use, belonging to social class IV, and failure to ensure contraception. The users needed hospital observation significantly more often during pregnancy (regular users, 80.8%; occasional users, 38.3; nonusers, 27.4%) and the adjustment of the background variables did not change this result. Of the pregnancy complications bleeding was significantly more common among users than nonusers (23.3 vs. 13.2%) and this difference was not explained by difference in background variables. The mean birth weight of infants of the regular users was significantly lower (255 g) when background variables were standardized by linear regression analysis. No association of increased number of birth defects was found with usage of psychotropic drugs.

Adult↗

[74 pregnancies despite a retained IUD].

The author's study of 74 pregnancies where an IUD had been inserted was unable to find any tangible reason for the failure of the contraceptive in 40 cases. In 26 cases, dislocation of the spiral was established, while in eight cases anatomical changes were presumed to be the reason for conception. Of the 154 "spiral pregnancies" recorded in Upper Austria in the study period (1984-1985), 92 (i.e., 77.3% of the 119 intact intrauterine pregnancies) culminated in termination, while there were 35 extrauterine pregnancies (22.7%). Of the remaining 27 pregnancies which went to term, there was not a single case of septic complication in the mother or of abnormality in the child. In the author's opinion this argument would seem to present a well-founded challenge to the widespread view that, for the sake of the mother or the fetus, termination is to be recommended if an IUD has been inserted.

Abortion, Incomplete↗

Trichomonas vaginalis: reevaluation of its clinical presentation and laboratory diagnosis.

Vaginal discharge is the most common complaint and Trichomonas vaginalis vaginitis the most frequently diagnosed problem among women attending the DeKalb County Georgia, Veneral Disease Clinic. Despite this prevalence, the 1837 observations of Donné are the criteria frequently used in the clinical and laboratory diagnosis of trichomoniasis. Our study shows that a purulent, frothy discharge is indeed a characteristic of trichomonal vaginitis, but if it is used as the sole diagnostic criterion, 88% of women with trichomonal vaginitis will not be identified and 29% will be erroneously diagnosed as infected. Donné's wet-mount test remains highly specific, but culture will detect twice as many trichomonas infections. There is a positive association between trichomoniasis and gonococcal cervicitis, failure to use contraceptive techniques, and lack of yeast in the wet mount of vaginal secretions.

Adolescent↗

Sperm-macrophage interaction in the mouse: a quantitative assay in vitro using 111indium oxine-labeled sperm.

The role of reproductive tract macrophages in contraception and reproductive failure has become widely recognized. However, in vitro analysis of sperm phagocytosis by macrophages has relied upon a semi-quantitative method of sperm counting that is of limited accuracy and reproducibility. We have developed an assay using murine sperm labeled with 111indium oxine, and results indicate the labeling to be rapid and efficient. Incorporation of 111indium into sperm increased the dose and sperm concentration and reached 90% maximal uptake after 15 min incubation, with maximal uptake occurring at 30 min. No decrease in sperm motility was noted with levels of oxine in excess of those required for significant labeling. Maximal labeling efficiency occurred in phosphate-buffered saline (PBS), with Dulbecco's modified Eagle's medium (DMEM) + 10% adult bovine serum (ABS) producing significantly less uptake. Label dissociation was detectable in PBS at room temperature, but at 37 degrees C in DMEM + 10% ABS, loss of label occurred at a rate of 23.5%/h. Addition of labeled sperm to murine macrophage monolayers under optimal conditions resulted in uptake of 111indium by macrophages, while free label was unincorporated. Results indicated assay specificity for macrophage-limited uptake, with insignificant label uptake by nonphagocytic murine fibroblasts and better sensitivity than sperm counting. Macrophages from Bacillus Calmette-Guerin (BCG)-infected mice resulted in a decrease in sperm uptake. Female macrophages showed greater capacity for sperm uptake than those of the male mouse. These initial studies demonstrated the utility of this model system in enhancing the understanding of sperm-macrophage interaction in the female reproductive tract.

Animals↗

Transcatheter tubal sterilization in rabbits. Technique and results.

RATIONALE AND OBJECTIVES: A potential method of nonsurgical tubal sterilization was tested in rabbits. METHODS: Metal coils were designed which could be placed into the uterotubal junction using transvaginal fluoroscopic fallopian tube catheterization. These metal coils were successfully placed unilaterally in the uterotubal junction of 32 rabbits. The contralateral fallopian tube and uterus were used as a control. The rabbits were bred, and the presence of pregnancies was confirmed by palpation. RESULTS: In 21 rabbits (66%), the coil stayed in place. Sixteen rabbits had multiple gestations on the side without the coil and no gestations on the side with the coil. Three rabbits had gestations on both sides, even though the coil was in place, and two rabbits never conceived. In 11 rabbits (34%) the coil was dislodged as early as 5 days and as late as 18 weeks after the procedure. Five of these 11 rabbits had bilateral embryos, 4 had embryos only on the side contralateral to where the coil had been, and 2 never conceived. CONCLUSIONS: The metal coil does prevent conception if it stays in place at the uterotubal junction. However, the coil failed to prevent pregnancy in 3 of 19 rabbits, and was dislodged in 11 rabbits, giving an overall failure rate for contraception of 44%.

Animals↗

Interactions between anticonvulsants and other commonly prescribed drugs.

Many drug interactions can be demonstrated, but only a few are so clinically significant that they necessitate adjusting drug dosages. The same drug combination may produce changes of variable extent or direction in different individuals. The reasons for this variability include genetic control of the rate and inducibility of drug metabolism, and environmental factors such as contact with chemicals. Among antimicrobial agents, chloramphenicol may cause accumulation of phenytoin (PHT) and phenobarbital (PB), and isoniazid may cause PHT, carbamazepine (CBZ), and primidone (PRM) to accumulate. Erythromycin may cause accumulation of CBZ. Among anti-ulcer agents, antacids may reduce PHT concentration while cimetidine may cause accumulation of PHT, CBZ, and diazepam (DZP). Salicylates displace strongly binding drugs such as PHT, DZP, or valproate (VPA) from the binding sites in plasma proteins, which may lead to some decline of the total plasma level with an increase in the unbound drug percentage. Conversely, anticonvulsants may influence the dosage requirements of oral anticoagulants by inducing their metabolism. Failures of oral contraceptives have been attributed to anticonvulsants in some patients. Probably the most predictable interaction that necessitates dosage adjustment is accumulation of PB caused by VPA. Intentional inhibition of PRM metabolism by nicotinamide serves as an example of attempts to utilize an interaction for improved therapeutic effect.

Analgesics↗

The new antiepileptic drugs and women: efficacy, reproductive health, pregnancy, and fetal outcome.

As new antiepileptic drugs (AEDs) become available, physicians will define their appropriate use in particular patient populations. For women, the issues include gender-specific efficacy and tolerability, including the impact of the AED on reproductive health. Women with epilepsy who are treated with established AEDs appear to be at risk for compromised bone health, for disturbances in fertility, menstrual cyclicity, ovulatory function, and sexuality and, with some AEDs, for failure of hormonal contraception. Finally, pregnancy outcome may be adversely affected by the established AEDs, all of which are human teratogens. Felbamate (FBM), gabapentin (GBP), lamotrigine (LTG), oxcarbazepine (OCBZ), tiagabine (TGB), topiramate (TPM), and vigabatrin (VGB) were reviewed. The preclinical development process had not addressed all the issues of concern to women. Although gender-specific efficacy is routinely evaluated, impact on reproductive health is not. FBM, GBP, LTG, TGB, TPM, and VGB have similar efficacy in women and men. It is not known whether the new AEDs will affect bone health, fertility, the menstrual cycle, and sexuality. FBM, GBP, LTG, TGB, and probably VGB do not interfere with hormonal contraception. Whether these new AEDs are good choices for the pregnant woman with epilepsy awaits further experience in human pregnancy. However, animal reproductive toxicology studies appear promising. The limited number of human pregnancy exposures do not, thus far, signal a significant number or particular type of adverse outcomes. However, only with improved postmarketing surveillance can essential information about teratogenic effects by acquired in an acceptably short time.

Abnormalities, Drug-Induced↗

[Reproductive health: some data and reflections].

Respect for human rights goes beyond the concept of reproductive health. The right to a responsible, satisfactory and safe sex life and the right to choose the number of children means that we must also concern ourselves with such concepts as fertility, unwanted pregnancy and assisted reproduction. Spain has one of the lowest birth rates in the world, with 1.24 children per woman. Data from a recent national survey showed that 7.2% of Spanish women are at risk for an unwanted pregnancy, either due to failure to use contraceptive measures or to use of poorly efficient measures. The abortion ratio, which has been increasing since 1992, was about 7 per 1000 women in 2001. On the other hand, although more and more couples are consulting with problems of sterility, the public health services do not appear to be covering their requirements.

Contraception↗

Drug interactions with phenytoin.

Drug interactions with phenytoin are a frequent occurrence, although their clinical relevance has often been overemphasised. Probably the most important of such interactions are those resulting in inhibition of phenytoin metabolism: due to the saturable nature of phenytoin biotransformation even minor degrees of inhibition can produce disproportionate changes in both steady-state serum concentration and the magnitude of pharmacological effect. Phenytoin has marked enzyme-inducing properties and can stimulate the metabolism of many concurrently administered drugs, thereby reducing their therapeutic efficacy. Clinically important examples of such interactions include a reduction of the anticoagulant effect of dicoumarol, a decrease in the prophylactic efficacy of the contraceptive pill and failure of response to various corticosteroid agents when administered therapeutically or diagnostically. Unless complicated by additional mechanisms, plasma protein binding interactions with phenytoin are seldom of clinical significance. However, they may alter considerably the relationship between serum drug concentration and clinical response, a possibility which needs to be taken into account when interpreting serum phenytoin levels in clinical practice.

Anticonvulsants↗

Teratogenic potential of the newer antiepileptic drugs: what is known and how should this influence prescribing?

The treatment of women of childbearing age who have epilepsy raises many questions because of the interactions between epilepsy, antiepileptic therapy and different aspects of reproductive life. Menstrual cycle disorders and reduced fertility have been partially ascribed to antiepileptic drugs (AEDs). Furthermore, most AEDs induce the cytochrome P450 (CYP) enzymatic system, altering the metabolism of sex hormones and contributing to the failure of oral contraceptives. Pregnancy represents, in this context, the most critical period because of the well known teratogenic potential of all established AEDs. For most of these drugs no specific patterns of malformations have been identified, although during the past few decades basic knowledge has been acquired, particularly concerning the mechanisms of AED-induced teratogenesis and related risk factors. These issues form the basis of the current guidelines for the management of epilepsy in pregnant women. In the past decade, several new AEDs have been introduced into clinical practice. For a number of reasons, these drugs appear to be more favourable than the older ones as treatments for epilepsy in women of childbearing age. They possess a good pharmacokinetic profile that makes them more stable during pregnancy, and they have a low potential for interaction with other drugs. They are also less likely than the older AEDs to be metabolised to compounds that are teratogenic. Furthermore, most of them do not possess antifolate properties. With the exception of topiramate and vigabatrin, the newer AEDs do not appear to be teratogenic in animals when administered in subtoxic doses. However, animal teratology may not be a reliable predictor of human teratogenicity, and there is a significant lack of information regarding the teratogenic profile of these newer agents in humans. Because clinical experience with these agents is limited, it is advisable to avoid exposure of the embryo to these drugs when pregnancy is planned. The establishment of pregnancy registries could allow for the rapid collection of data related to the administration of new AEDs in pregnancy and the outcomes of such exposure.

Abnormalities, Drug-Induced↗

Uncommon problems of the double uterus.

Although often asymptomatic, congenital anomalies of the uterus may be associated with many gynaecological and obstetrical problems. The double uterus should always be considered in cases of severe dysmenorrhoea and chronic pelvic pain; in cases of the failure of intrauterine contraceptive devices; in cases of a symptomatic or asymptomatic pelvic mass that is inseparable from the uterus; in cases where termination of pregnancy has been unsuccessful; and in cases of cervical incompetence. Where uterine malformations are overlooked patients may not be treated properly before excessive fetal wastage occurs and may undergo extensive surgical procedures that may terminate fertility. Clinical suspicion, accurate documentation of curettage findings and the increased use of hysterography and, especially, ultrasound enable earlier diagnoses and the application of the correct treatment.

Abnormalities, Multiple↗