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Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.

OBJECTIVE: To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability. METHODS: We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception. We tested for pregnancy at enrollment and at every scheduled follow-up visit (weeks 4, 10, 16, 22, and 30). RESULTS: The 6-month typical-use pregnancy probabilities were 9.0% (95% confidence interval [CI] 5.9, 12.2) for the polyurethane group and 5.4% (95% CI 2.9, 7.8) for the latex group; the hazard ratio was 1.7 (95% CI 1.1, 2.7), and we failed to reject the null hypothesis of our test of noninferiority. Females in the polyurethane group reported fewer genital irritations (hazard ratio 0.6; 95% CI 0.5, 0.8; P <.01), whereas males in both groups reported the same number of genital irritations (hazard ratio 1.0; 95% CI 0.7, 1.5; P =.94). Total clinical failures (breakage and slippage) were 8.4% for the polyurethane condom and 3.2% for the latex condom (difference 5.3%, 90% CI 2.8, 7.7). The risk of discontinuation did not differ between groups. Participants judged both condoms favorably in terms of the four primary acceptability outcomes (willingness to purchase, willingness to recommend, confidence in method, and general comfort). CONCLUSION: The polyurethane condom was not shown to be as effective as the latex comparator condom for pregnancy prevention. However, the risk of pregnancy in the polyurethane group falls in the range of other barrier methods. For people with latex sensitivity or who find latex condoms unacceptable, this polyurethane condom represents one of several synthetic male condom alternatives currently available on the US market.

Adolescent↗

Outcomes of adolescents using levonorgestrel implants vs oral contraceptives or other contraceptive methods.

OBJECTIVE: To compare outcomes among adolescents who use levonorgestrel implants, oral contraceptives, or other methods of birth control. DESIGN: Prospective, longitudinal study of 166 females who were followed up for 6 months. Fifty-four used implants, 64 used oral contraceptives, and 48 used condoms alone or with spermicide, or no contraceptive. Outcomes were measured by patient interview and medical chart review. SETTING: Inner-city, hospital-based adolescent and teenaged mother and baby clinic between April 1, 1992, and May 31, 1993. PARTICIPANTS: Sexually active 12- to 18-year-old females at least 1 year postmenarche who had no contraindications to use of hormonal contraceptives. MAIN OUTCOME MEASURES: Sexual activity, pregnancy rates, condom use, incidence of sexually transmitted disease, patient satisfaction continuation rates, and side effects. RESULTS: Despite similar reports of sexual activity, one subject who used the implant (2%) vs 13 subjects who used oral contraceptives (20%), and eight subjects who used other methods (17%) became pregnant (chi 2, P < .50). Condom use did not differ among groups (chi 2, P > .60). Overall, 30% of subjects contracted a new sexually transmitted disease; rates did not differ by method (chi 2, P = .92). Implant users were more likely than oral contraceptive users to continue their method (87% vs 50%; chi 2, P < .001) despite similar satisfaction scores (one-way analysis of variance, P = .52). Implant users were more likely to experience irregular menses, mood swings, acne, and hair loss (chi 2, P < .05). CONCLUSIONS: In this population, the levonorgestrel implant is an effective method of pregnancy prevention and is associated with high satisfaction and continuation rates at 6 months. Implant users are not at greater risk than others for sexually transmitted disease. Health care providers should continue to stress the use of barrier methods to all sexually active adolescents.

Adolescent↗

[Profile of the women attending a service of family planning].

OBJECTIVES: To find the profile of the Family Planning (FP) service, the contraceptive methods used, prescribed and asked for, evaluating the knowledge acquired in the prior informative talk. DESIGN: A crossover observational study. SETTING: Family Planning service in Telde (Gran Canaria). PATIENTS AND PARTICIPANTS: 317 users for whom a clinical record was opened in 1992/3. MEASUREMENTS AND MAIN RESULTS: Average age was 28.23 +/- 0.75 (SD 6.76); 77.6% were married, 66.56% without paid work and 22.71% with medium or higher education. 62.77% were from our Health Area. 82.33% attended on their own initiative. 2.26 +/- 0.07 (SD 0.59) contraceptive methods per user were used, with 71.87% medically monitored. 98.74% had used hormonal contraception (HC). The average number of pregnancies was 1.45 +/- 0.13 (SD 1.2), with the first being on average at age 22.16 +/- 0.48 (SD 3.74). 32.67% used barrier methods and 35.31% hormonal ones (36.4% smoked), with significant differences for age-groups, the referring professional and the number of children. 60% asked for an IUD and 37.38% HC, where significant differences were found for marital status, age groups, educational level and the number of children. CONCLUSIONS: We must strengthen the FP service so that people can make the most of their sexual and reproductive lives, increasing coverage for adolescents to prevent unwanted pregnancies and avoid uncontrolled risky contraceptive methods. The information in the prior talks should be improved, which would make the questionnaires administered more valid.

Adolescent↗

Ocular fluorescein kinetics before and after vitrectomy on swine.

PURPOSE: To study the quantitative effects of vitrectomy on fluorescein transport kinetics across the ocular barriers. METHODS: Thirty-six domestic swine were used in this study. Twenty anesthetized swine were given a standardized fluorescein intravenous injection immediately after unilateral vitrectomy. This was followed by one single central sample aspiration from the vitreous and the anterior chamber of both eyes in individual animals at increasing intervals up to 24 h after the injection. Fluorescein concentrations in the samples were determined by high-pressure liquid chromatography (HPLC). Eight swine underwent unilateral vitrectomy followed by anterior chamber and vitreous fluorophotometry on both eyes 1 month later. The fluorescein concentrations determined using this method were followed for 24 h. Similar examinations were performed in a control group of eight swine that did not undergo vitrectomy. Anterior chamber, vitreous, and plasma fluorescein concentration/time courses were analyzed kinetically by iterative nonlinear regression analysis. RESULTS: The barrier surrounding the anterior chamber of the eye was immediately impaired after vitrectomy, as evidenced by an increased area under the fluorescein concentration versus time curve, but the transport kinetics were restored within 1 month after surgery. The blood-retinal barrier was, however, persistently altered following vitrectomy. Transport rate and extent of drug penetration into the vitreous were increased, while drug elimination from the vitreous remained unchanged. CONCLUSION: Vitrectomy led to persistent kinetic fluorescein transport changes in the blood-retinal barrier resulting in faster and increased drug penetration to the vitreous, whereas similar alterations in the anterior chamber barrier transport were only transitory.

Animals↗

Current reversible contraceptive methods: a global perspective.

Since the 1960's, there have been important gains in the efforts to make the benefits of family planning accessible to people around the world. However, prevalence of contraceptive use is still low in some areas, especially in sub-Saharan Africa. Making contraceptives accessible through good quality services should be a goal for reproductive health programs. In the absence of an ideal method of contraception which would suit every individual, there is a variety of contraceptive methods with advantages in some aspects and disadvantages in others from which people should be able to choose according to their particular characteristics and needs. Important aspects to take into consideration include effectiveness, convenience, and safety. In general, the most effective methods are more likely to have some side effects and method-related complications. However, when weighing the risks and benefits, the most effective methods have greater benefits on the health of women by protecting them better from the health risks of unwanted pregnancies. Most methods also have non-contraceptive benefits - for instance, combined oral contraceptives (COCs) provide important degrees of protection against endometrial and ovarian cancers, benign breast disease, pelvic inflammatory disease (PID), and ectopic pregnancy. They also reduce menstrual blood loss. Although barrier methods have lower effectiveness against pregnancy, their most important advantage is the protection they can provide against sexually transmitted diseases. The male condom in particular (and probably the female condom) has the special value of providing protection against HIV infection. This paper describes reversible methods of contraception including possible health risks and contraindications. Adequate counseling, however, is essential for people to make an appropriate choice of contraception and to secure safe and effective use of the method.

Choice Behavior↗

Clinical trials methods and the practice of medicine.

An important potential byproduct from clinical trials is validated clinical methods applicable to clinical practice. The potential for improved patient care is separate from the scientific and intellectual answers gained in such trials. The current mechanisms for the transfer of methodological information from clinical trials are inefficient and have identifiable barriers. Methods validated in clinical trials must be recognized and accentuated as a valuable resource. A central repository of clinical trials' methods and a retrieval system dedicated to this unique body of scientific literature is warranted. Reports of methodological advances from clinical trials should be published in the literature read by clinical practitioners. The effective transfer of methods information from clinical trials to the office of the clinical practitioner is possible but requires increased efforts on the part of clinical trials scientists.

Clinical Trials as Topic↗

Long-term results of guided tissue regeneration therapy with non-resorbable and bioabsorbable barriers. II. A case series of infrabony defects.

BACKGROUND: The aim of this 5-year follow-up case series was to clinically and radiographically evaluate the long-term results after guided tissue regeneration (GTR) therapy of infrabony defects using non-resorbable and bioabsorbable barriers. METHODS: In 12 patients with advanced chronic periodontitis 12 pairs of contralateral infrabony defects were treated. Within each patient one defect received a non-resorbable (expanded polytetrafluoroethylene [ePTFE]; control: C) and the other a bioabsorbable (polyglactin 910; test: T) barrier by random assignment. At baseline and at 6 and 60 +/- 3 months after surgery clinical parameters and standardized radiographs were obtained. Gain of bone density within infrabony defects was assessed using subtraction radiography. RESULTS: Eight of 12 patients were available for the 60-month reexaminations. Six and 60 +/- 3 months after GTR therapy statistically significant (P < 0.05) vertical attachment (CAL-V) gain was observed in both groups (C6:2.6 +/- 1.4 mm; C60: 1.6 +/- 1.5 mm; T6:3.0+/- 1.7 mm; T60: 3.0 +/- 0.7mm). However at 60 months, 2 infrabony defects in the control group had lost all the attachment that had been gained 6 months after therapy and a clinically relevant but statistically in significant mean CAL-V loss of 1.0 +/- 2.1 mm was observed from 6 to 60 months. The case series failed to show statistically significant differences between test and control regarding CAL-V gain 60 months after surgery. Also subtraction analysis failed to reveal statistically significant differences regarding density gain between both groups 6 and 60 months postsurgically (C6: 26.4 +/- 54.2; C60 62.8 +/- 112.7; T6: 68.7 +/- 72.8; T60. 84.1 +/- 83.6). CONCLUSIONS: CAL-V gain achieved after GTR therapy in infrabony defects using both non-resorbable and bioabsorbable barriers was quite stable after 5 years in 14 of 16 defects.

Absorbable Implants↗

Dual protection against sexually transmitted infections and pregnancy in South Africa.

Promotion of simultaneous protection against sexually transmitted infections (STIs) and unintended pregnancy, referred to as dual protection, represents an important public health intervention. We investigated its prevalence and correlates in South Africa. A cross-sectional survey of 929 sexually active women, aged 15-49 years, was conducted in 89 public primary health care clinics, with dual method use and use of condom alone at last sexual intercourse as outcomes. At last intercourse, 12% of women were protected from both STIs and pregnancy. In multivariate analysis, higher education, being unmarried, and multiple sex partnership in the past year were predictors of dual method use, while younger age, higher education and awareness of the dual function of condoms were predictors of condom use alone. Dual protection is low in this population. The predominance of hormonal contraceptive use in South Africa means that increasing barrier method use among hormonal contraceptive users is an important strategy for increasing dual protection.

Adolescent↗

Calendar rhythm efficacy: a review.

OBJECTIVE: To estimate the unplanned pregnancy rate of calendar rhythm. DESIGN: Meta-analysis of eight studies of calendar rhythm published between 1940 and 1989. RESULTS: There exist few studies of the calendar rhythm method. Analysis of the best of these studies resulted in a conservative estimated Pearl rate of 18.5 +/- 1.8, and a less conservative estimate of 15.0 +/- 4.0, standardized to 12 months' observation; these results are in the range of other natural and barrier methods. DISCUSSION: We need properly done clinical trials of the calendar rhythm method to scientifically establish its effectiveness.

Female↗

Male adolescent sexual behavior, the forgotten partner: a review.

It is encouraging that after years of focusing attention on the female's ability and responsibility to manage her reproductive behavior, the male is finally beginning to receive notice and attention. Ironically, before the widespread use of the Pill and the IUD, men and male birth control methods played an important role in family planning. Even today, reliance on vasectomies, the condom and withdrawal account for 25% of the contraceptive use among couples and trend statistics point to an increased interest among selected populations in the use of barrier methods that require partner cooperation for effective use. Yet, most small scale and nationwide knowledge, attitudes and practice (KAP) studies focus on the female, particularly the teen-age female. With the exception of fragmentary survey data, pertinent information about male adolescent sexual activity is virtually nonexistent. The growing consensus among researchers and planners is that it is now crucial to research the forgotten partner--the adolescent male.

Adolescent↗

Adhesions.

Although several decades have passed since the first theories concerning normal healing and adhesion formation processes were proposed, the possible role of some factors is still under investigation. The availability of recombinant murine interleukin-1 allowed the assumption that interleukin-1 may be an important short-term mediator of adhesion formation. The definite effect of prostaglandin E2 on adhesion formation was also further elucidated, whereas prostaglandin F2 alpha was found to play a minimal role in the inflammatory process, which is the initial step in the pathogenesis of adhesions. The development of recombinant tissue plasminogen activator offers a unique alternative to augment the depressed endogenous fibrinolytic system. Intraperitoneal application of recombinant tissue plasminogen activator to injured animal models showed significant reduction in both de novo and reformation of adhesions. The presumption that operative laparoscopy is more beneficial than laparotomy with regard to postoperative adhesion development is demonstrated by the latest studies on this topic. Recently developed barrier methods, including natural or synthetic materials, have been tested in animal models and appear promising in reducing both formation and reformation of adhesions. Until these are introduced in clinical practice, the immediate future will certainly involve the further expansion of absorbable barriers.

Female↗

[New trends in contraception].

Since the beginning of the world, humans are trying to find methods to allow the control of their fertility. Up to the present, more than a hundred methods of contraception were developed, most of them being derivatives from the first hormonal used methods. The reality of the modern world has imposed the necessity of focusing the research in this field in order to develop the "ideal contraceptive". There are three main areas of research, with already encouraging results: various combinations of hormonal and barrier methods, the contraceptive vaccines, and the systemic methods for men. This article presents a synthesis of the latest contraceptive technologies available on the market, and the main areas of research in this field, separated by gender.

Contraception↗

Pharmacists' concerns and perceived benefits from the deregulation of hormonal emergency contraception (HEC).

OBJECTIVE: To ascertain pharmacists' views, assess willingness for involvement and delineate individual perceived competence in the supply of deregulated hormonal emergency contraception (HEC). DESIGN: Cross-sectional postal questionnaire utilising closed, open and Likert-scale questions. SUBJECTS: Three thousand nine hundred and ninety-nine registered pharmacists abstracted from the mailing list of the Royal Pharmaceutical Society of Great Britain. RESULTS: In total 1543 (38.6%) questionnaires were returned and analysed. Overall 1165 (75.5%) of pharmacists stated their willingness to be involved in the deregulated supply of HEC. However, pharmacists identified the need for specific training before effective deregulation should take place. Overall, 616 (39.9%) of respondents felt individually competent to supply deregulated HEC with a positive association between perceived competence and willingness to supply deregulated HEC (p < 0.05). Pharmacists perceive the major benefits of deregulation to be a reduced unwanted pregnancy rate and a subsequent reduced abortion rate. They perceive that deregulation would allow quicker and less restricted access to HEC by clients, facilitating an increased overall supply of HEC. Pharmacists express a number of concerns, tempering their collective desire to see HEC deregulation. The majority of these concerns related to safeguarding clients and the possible adverse public health effects associated with the possible reduced use of barrier methods of contraception. CONCLUSIONS: Most pharmacists would be willing to supply HEC if it were deregulated to 'pharmacy only' from 'prescription only' medicine status. Although concerns were raised, these were mainly related to safety issues, with few pharmacists identifying moral and ethical barriers to deregulation. For effective deregulation to occur issues of professional competence need to be addressed.

Abortion, Induced↗

Contraception.

Prescribing and reviewing contraceptive methods with adolescents involves a significant amount of time and resources. Health care providers need to be familiar with how teens think about sex and birth control, what their beliefs are, and how individual teens may make different choices based on their lifestyles. Barrier methods remain popular in that they are accessible and do not require a clinician visit. The hormonal choices need to be explained fully in plain language and selections based on these sessions made appropriately. Teens can be effective users of contraception if they are given the appropriate tools, access, and knowledge.

Adolescent↗

Influence of antenatal steroids and sex on maturation of the epidermal barrier in the preterm infant.

BACKGROUND: The epidermal barrier is well developed in term infants but defective in the immature infant with important clinical consequences. The development of the barrier shares similarities with production of pulmonary surfactant. Studies in the rat have shown that barrier maturation is accelerated by antenatal steroids, both structurally and functionally. Females have a more mature barrier than males at the same gestational age. These factors have not been studied in the human. AIM: To examine the influence of antenatal steroids and sex on maturation of the epidermal barrier in the preterm infant. SUBJECTS: A total of 137 infants born before 34 weeks gestation, 80 boys and 57 girls, were studied: 87 had been exposed to antenatal steroids, and 50 had not; 99 were studied prospectively, and 38 had been studied previously. METHOD: Barrier function was measured as transepidermal water loss from abdominal skin by evaporimetry. Measurements were made within the first 48 hours and corrected to a standard relative humidity of 50% (TEWL(50)). RESULTS: The relation between TEWL(50) and gestation was exponential with very high levels in the most immature infants. No influence of antenatal steroids or sex could be shown. When infants who were optimally exposed to antenatal steroids were considered alone, no effect could be shown. CONCLUSION: Epidermal maturation in the preterm infant does not appear to be influenced by antenatal steroids or sex, suggesting that the mechanism of maturation differs from that of the rat.

Dexamethasone↗

Contraception for women with diabetes: an update.

Today several effective contraceptive methods are available for women with IDDM. Contraceptive guidance as part of the pre-pregnancy counselling needs to be more widely implemented by general practitioners and in non-specialized obstetrical and gynaecological departments. Women with diabetes are generally well motivated, and thus the barrier methods may prove both acceptable and reliable contraceptive agents for some of these women. When, however, a high risk of user failure can be predicted, the IUD or hormonal contraception may be the only reversible alternative. According to our findings, IUDs can be recommended without reservation to women with IDDM. In women with previous GDM it seems that low dose oral contraceptive compounds may be administered without running the risk of inducing glucose intolerance, but long-term results are still unavailable. Natural oestrogens may be administered in combination with a progestogen for a limited period as an efficient and acceptable mode of contraception in women with IDDM without any concomitant adverse effects on diabetic control. From our investigations it also appears that short-term administration of combined low dose OCs containing the traditional progestogens (e.g. norethisterone or levonorgestrel) or the new gonane progestogens (e.g. gestodene) does not alter glycaemic control in women with IDDM. Similarly, these compounds do not cause any significant changes in lipid/lipoprotein levels during short-term treatment, although the intake of monophasic ethinyloestradiol/norethisterone preparations may result in higher triglyceride levels and tends to increase lipid levels more than triphasic ethinyloestradiol/levonorgestrel compounds. The results from our clinic have shown that OCs can be safely recommended at pre-conception counselling so that women with diabetes can obtain both optimal glycaemic control and efficient spacing of their pregnancies.

Contraception↗

Circulating leptin has saturable transport into intrathecal space in humans.

BACKGROUND: Leptin is an adipocyte-derived hormone that is thought to provide a negative feedback signal to control body fat mass by interacting with its hypothalamic receptor. The present study was undertaken to examine the uptake of leptin in cerebrospinal fluid (CSF) space in humans and whether the transport of leptin into CSF space is an active phenomenon or due to free access through the blood-CSF barrier. METHODS: We determined serum and CSF leptin concentrations by radioimmunoassay in 17 men [42 +/- 4 years, mean +/- SE; body mass index (BMI) 27.3 +/- 1.8 kg m-2] and 22 women (40 +/- 3 years, BMI 25.1 +/- 1.0 kg m-2). The function of the blood-CSF barrier was evaluated by determining the CSF/serum albumin ratio. RESULTS: Serum leptin concentration was lower in male (5.8 +/- 1.6 microgram L-1) than in female subjects (13.1 +/- 1.7 microgram L-1, P = 0. 001), whereas the concentrations of leptin in CSF were virtually identical in male (0.34 +/- 0.03 microgram L-1) and female (0.36 +/- 0. 03 microgram L-1) subjects. Serum leptin was correlated positively with BMI both in men (r = 0.89, P < 0.01, n = 10) and in women (r = 0.61, P < 0.05, n = 14), whereas no correlation between CSF leptin concentration and BMI was found in either group. The CSF/serum leptin ratio correlated negatively with serum leptin concentration both in men (r = -0.93, P < 0.001) and in women (r = -0.77, P < 0. 001) and with BMI both in men (r = -0.75, P = 0.02, n = 10) and in women (r = -0.64, P < 0.02, n = 14). The CSF/serum albumin ratio was not correlated with the CSF/serum leptin ratio in either group. CSF leptin concentrations and the CSF/serum leptin ratio were virtually identical in subjects with impaired and normal blood-CSF barrier function. CONCLUSION: Thus, our data support the presence of a saturable and active transporter of leptin from circulation into intrathecal space.

Adipose Tissue↗

Contraceptive use and attitudes in reunified Germany.

Contraceptive use and attitudes were assessed in a random sample of 1064 German women. The majority (76%) of the sexually active, fertile women who were not pregnant and did not wish to get pregnant at the time of the survey were using very reliable contraceptive methods, namely oral contraceptives (OCs), intrauterine devices (IUDs) or sterilization. Comparison with a previous survey showed that contraceptive practice in West Germany had improved considerably since 1985. Attitudes towards the most reliable methods available (OCs, IUDs and sterilization) were found to be ambivalent. Perceived side effects and health risks were a particular matter of concern to the respondents. Although most respondents (88%) recognized that condoms prevent the transmission of AIDS, 66% of those who had occasional sexual partners did not use barrier methods. It is concluded that German contraceptive practice is reasonably effective and that if attitudes were to become more realistic the level of effectiveness could even be raised.

Adolescent↗