Optimizing the design of a contraceptive microarray patch: a discrete choice experiment on women's preferences in India and Nigeria.

BACKGROUND: Efforts are underway to develop an easy-to-use contraceptive microarray patch (MAP) that could expand the range of self-administrable methods. This paper presents results from a discrete choice experiment (DCE) designed to support optimal product design. METHODS: We conducted a DCE survey of users and non-users of contraception in New Delhi, India (496 women) and Ibadan, Nigeria (two versions with 530 and 416 women, respectively) to assess stated preferences for up to six potential product attributes: effect on menstruation, duration of effectiveness, application pain, location, rash after application, and patch size. We estimated Hierarchical Bayes coefficients (utilities) for each attribute level and ran simulations comparing women's preferences for hypothetical MAPs with varying attribute combinations. RESULTS: The most important attributes of the MAP were potential for menstrual side effects (55% of preferences in India and 42% in Nigeria) and duration (13% of preferences in India and 24% in Nigeria). Women preferred a regular period over an irregular or no period, and a six-month duration to three or one month. Simulations show that the most ideal design would be a small patch, providing 6 months of protection, that would involve no pain on administration, result in a one-day rash, and be applied to the foot. CONCLUSIONS: To the extent possible, MAP developers should consider method designs and formulations that limit menstrual side effects and provide more than one month of protection.

U.S. Selected Practice Recommendations for Contraceptive Use, 2016.

The 2016 U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR) addresses a select group of common, yet sometimes controversial or complex, issues regarding initiation and use of specific contraceptive methods. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2013 U.S. SPR (CDC. U.S. selected practice recommendations for contraceptive use, 2013. MMWR 2013;62[No. RR-5]). Major updates include 1) revised recommendations for starting regular contraception after the use of emergency contraceptive pills and 2) new recommendations for the use of medications to ease insertion of intrauterine devices. The recommendations in this report are intended to serve as a source of clinical guidance for health care providers and provide evidence-based guidance to reduce medical barriers to contraception access and use. Health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Long-term risk of reproductive cancer among Vietnamese women using the quinacrine hydrochloride pellet system vs. intrauterine devices or tubal ligation for contraception.

OBJECTIVES: To determine the long-term risk of reproductive tract cancer in women using the quinacrine hydrochloride pellet system of permanent contraception (QS) relative to the comparable risk in women using Copper T intrauterine device (IUD) or tubal ligation surgery (TL) for long-term or permanent contraception. METHODS: This was a retrospective cohort study, conducted in the Northern Vietnamese provinces of Ha Nam, Nam Dinh, Ninh Binh and Thai Binh. Women who had their first QS procedure, last IUD insertion or TL between 1989 and 1996 were interviewed regarding post-procedure health outcomes, particularly reproductive tract cancers. RESULTS: A 95% response rate resulted in 21,040 completed interviews. Reproductive cancer incidence rates were very low (5.77/100,000 women years of follow-up time; 95%CI = 3.72-8.94). No significant excess hazard of reproductive tract cancer was associated with QS. CONCLUSIONS: No significant excess long-term risk of reproductive tract cancer was found after an average 16 years of follow-up among a large group of women using QS vs. IUD/TL for contraception.

Candida vaginitis during contraceptive use: the influence of methods, antifungal susceptibility and virulence patterns.

No consensus exists about whether contraceptives cause an increased risk of vaginitis, including vulvovaginal candidosis (VVC). We investigated 495 women (252 who used contraceptives; 243 who did not) for the presence of VVC. Antifungal susceptibility testing was performed for five antifungal agents and for boric acid, and three virulence factors were also examined. We recovered 129 (26.1%) monofungal populations from vaginal samples of women with acute VVC (AVVC, n = 18), symptomatic recurrent VVC (RVVC, n = 22) and asymptomatic RVVC (n = 28), as well as of other contraceptive users who carried Candida in their vaginas (n = 61). It is important to note that the women who had VVC used the same contraceptive methods (p > 0.05). Candida albicans was the most common species isolated (45%), followed by C. glabrata (40.3%). Most of the vaginal yeast isolates exhibited low minimum inhibitory concentration levels for the five antifungals tested. However, this was not the case for boric acid. In addition, the yeast fungi that was derived from the AVVC and RVVC patients showed higher amounts of haemolytic activity than the yeast fungi found among the controls (p < 0.05). The use of contraception does not predispose women to VVC (p > 0.05). Also, both host- and organism-related factors were required to achieve optimal clinical treatment for VVC.

Does contraceptive treatment in wildlife result in side effects? A review of quantitative and anecdotal evidence.

The efficacy of contraceptive treatments has been extensively tested, and several formulations are effective at reducing fertility in a range of species. However, these formulations should minimally impact the behavior of individuals and populations before a contraceptive is used for population manipulation, but these effects have received less attention. Potential side effects have been identified theoretically and we reviewed published studies that have investigated side effects on behavior and physiology of individuals or population-level effects, which provided mixed results. Physiological side effects were most prevalent. Most studies reported a lack of secondary effects, but were usually based on qualitative data or anecdotes. A meta-analysis on quantitative studies of side effects showed that secondary effects consistently occur across all categories and all contraceptive types. This contrasts with the qualitative studies, suggesting that anecdotal reports are insufficient to investigate secondary impacts of contraceptive treatment. We conclude that more research is needed to address fundamental questions about secondary effects of contraceptive treatment and experiments are fundamental to conclusions. In addition, researchers are missing a vital opportunity to use contraceptives as an experimental tool to test the influence of reproduction, sex and fertility on the behavior of wildlife species.

User preferences for a contraceptive microarray patch in India and Nigeria: Qualitative research on what women want.

BACKGROUND: A new contraceptive microarray patch (MAP) for women is in development. Input on this method from potential end-users early in the product development process is important to guide design decisions. This paper presents the qualitative component of a broader study exploring initial acceptability of the MAP and selected product features. The qualitative research was intended to identify product features that are most salient to end-users and to contextualize preferences around them with subsequent research planned to assess quantitatively the relative importance of those features. METHODS: We conducted 16 focus group discussions and 20 in-depth interviews with women and 20 IDIs with family planning providers in New Delhi, India, and Ibadan, Nigeria. Input from the MAP developer served to identify plausible features of the MAP to include in the focus group discussions and in-depth interviews. Interviews were audio-recorded, transcribed into English, coded, and analyzed to examine key dimensions of MAP features. RESULTS: Many participants viewed the MAP as potentially easy to use. Interest in self-application after learning correct use was high, especially in India. Participants favored formulations affording protection from pregnancy for three or six months, if not longer. Interest in a shorter-acting MAP was particularly low in Nigeria. Non-desirable MAP features included a potential localized skin rash and pain at application. Views on patch size and location of application were related to the potential for rash and pain, with a desire to permit discreet use and minimize pain. Results indicate that the side effect profile, effectiveness, and pricing are also important factors for acceptability and uptake of a future product. CONCLUSION: Study findings indicate that a contraceptive MAP is of potential interest to women and that specific MAP attributes will be important to acceptability.

Cervical dysplasia and cancer and the use of hormonal contraceptives in Jamaican women.

BACKGROUND: This study was conducted to determine whether use of hormonal contraceptives is associated with cervical dysplasia and cancer in a population where there is widespread use of hormonal contraception and the rates of cervical cancer remain high at 27.5/100,000. METHODS: A case-control study was conducted among women visiting the colposcopy and gynaelogical clinics at a tertiary referral hospital. Two hundred and thirty six cases CIN I (72), II (59), III (54), cancer (51) and 102 controls, consented and were interviewed on use of contraceptives using a structured questionnaire. Logistic regression was used to determine odds ratios (ORs) and 95% confidence intervals (CIs) associated with use of hormonal contraception in cases and controls and in low and high risk cases. Recruitment was carried out from 2001-2002. RESULTS: Contraceptives used were: oral contraceptives - 35%, injections (depot medroxy progesterone acetate (Depo-provera) - 10%, Intrauterine devices - 2%, combinations of these and tubal ligation - 30%. 23% reported use of 'other' methods, barrier contraceptives or no form of contraception. Barrier contraceptive use was not significantly different between cases and controls. Current and/or past exposure to hormonal contraceptives (HC) by use of the pill or injection, alone or in combination with other methods was significantly higher in the cases. In multivariate analysis with age and number of sexual partners as co-variates, use of hormonal contraception was associated both with disease, [OR, 1.92 (CI 1.11, 3.34; p = 0.02] and severity of the disease [OR, 2.22 (CI 1.05, 4.66) p = 0.036]. When parity and alcohol consumption were added to the model, hormonal contraception was no longer significant. The significant association with high risk disease was retained when the model was controlled for age and number of sexual partners. Depo-provera use (with age and number of sexual partners as covariates) was also associated with disease [OR, 2.43 (CI 1.39, 4.57), p = 0.006] and severity of disease [OR 2.51 (1.11, 5.64) p = 0.027]. With parity and alcohol added to this model, depo-provera use retained significance. Exposure to HC > 4 years conferred more risk for disease and severity of disease. CONCLUSION: Hormonal contraception did confer some risk of dysplasia and women using HC should therefore be encouraged to do regular Pap smear screening.

Retrieval of foreign bodies adjacent to the nervous system: aspects of intra-operative use of ultrasound.

The retention of a foreign body during a surgical procedure or the inadvertent migration of an implant are rare but potentially harmful complications. Especially in the case of the former, the legal situation is unequivocal. Nevertheless, the uncomplicated removal and limitation of the operative trauma may be in the interest of the surgeon. We report and illustrate 2 patients in whom the use of intra-operative ultrasound resulted in the safe and elective removal of an intracranial drill tip in one patient and a contraceptive implant located in the ulnar nerve sheath in the other. The characteristic acoustic shadowing artefact could be demonstrated in both examples. In the first patient, intra-operative magnetic resonance tomography could not be used because of the magnetic artefact, and in the second patient, ultrasound was preferred for reasons of simplicity. Intra-operative ultrasound is an appropriate and easily available tool for detection of small foreign bodies beneath the nervous system. The neurosurgeon should be familiar with the typical characteristics of foreign bodies, which is different from other structures.

[Efficacy and adverse effects of hormonal contraceptives: comparative study]. / Eficacia y efectos adversos de anticonceptivos hormonales. Estudio comparativo.

OBJECTIVE: to determine the efficacy and adverse effects of subdermic implants, oral and injectable contraceptives. METHODS: the study was conducted by using a cross-sectional design. The efficacy was measured by using the Pearl Index (PI) and the adverse effects were registered in each type of contraceptive: oral, injectable and subdermic implant. RESULTS: 264 users were included, the median age was 23.6 years and the mean weight was 54.48 kg. 23.1 % were oral contraceptives users; 15.7 % were using injectable contraceptives and 56.8 % were using subdermic implants. The average time of contraceptive use was 13.4 months. Regarding efficacy, the subdermic implants had a PI of 0; oral contraceptives showed a PI of 0.13, and the PI of injectable contraceptives was 0. Regarding adverse effects, these were reported by 84.7 % of subdermic implants users, 18.0 % of oral users and 23.3 % of injectable users. CONCLUSION: the efficacy of these three types of contraceptives is appropriate. The adverse effects are more frequent among implants users. The oral and injectable hormonal are effective and safe as contraceptive method and show less adverse effects than subdermic implants.

Pre- and postconception factors associated with sporadic heritable and nonheritable retinoblastoma.

A matched case-control study of retinoblastoma was conducted by the Children's Cancer Study Group (CCSG) to investigate the hypotheses that postconception exposures affect the risk of the nonheritable (post-zygotic origin) form of this disease and that preconception exposures affect the risk of the sporadic heritable (prezygotic origin) form. Eligible cases were those patients with retinoblastoma diagnosed in 1982-1985 at any of the CCSG member hospitals. Cases were classified as familial heritable, sporadic heritable, or nonheritable based on family history, tumor laterality, and cytogenetic analysis. Telephone interviews of parents of 201 cases and their pair-matched controls selected by random digit dialing were completed. Analysis of possible risk factors for the 67 sporadic heritable cases and the 115 nonheritable cases was performed. (The 19 familial cases were excluded). For the nonheritable group, gestational exposure to X-ray [odds ratio (OR) = 2.3, P = 0.08] and morning sickness medication (OR = 2.8, P = 0.02) and low maternal educational level (OR = 5.5, P = 0.03) were associated with increased risk; anemia (OR = 0.3, P = 0.02) and multivitamin use (OR = 0.4, P = 0.03) during pregnancy and periconceptional use of barrier contraceptive (OR = 0.1, P = 0.02) or spermicide (OR = 0.2, P = 0.02) were associated with decreased risk. In the sporadic heritable group, observations included a negative association with multivitamins during pregnancy (OR = 0.2, P = 0.02) and nonsignificant positive associations with preconception gonadal X-ray (maternal, OR = 2.0, P = 0.30; paternal, OR = 1.8, P = 0.42) and older parental age (case-control difference 1.0-1.2 years, P = 0.24-0.27). Many of the associations support study hypotheses, although the possibility of recall bias and chance findings suggest cautious interpretation.

Comparison of family-planning service quality reported by adolescents and young adult women in Mexico.

OBJECTIVE: Associations between age and patient-reported quality of family planning services were examined among young women in Mexico. METHODS: A repeated cross-sectional analysis of survey data collected in 2006, 2009, and 2014 was performed. Data from women aged 15-29years who had not undergone sterilization and were currently using a modern contraceptive method were included. The primary outcome was high-quality care, defined as positive responses to all five quality items regarding contraceptive services included in the survey. Multivariable logistic regression and marginal probabilities were used to compare adolescents and women aged 20-29years. The responses of respondents using different contraceptive methods were compared. RESULTS: Data were included from 15 835 individuals. The multivariable analysis demonstrated lower odds of reporting high-quality care among women aged 15-19years (odds ratio 0.73; 95% confidence interval 0.60-0.88) and 20-24years (odds ratio 0.85; 95% confidence interval 0.75-0.96) compared with women aged 25-29years. Adolescents using hormonal and long-acting reversible contraception had significantly lower odds of reporting high-quality care compared with women aged 25-29. CONCLUSIONS: Adolescents in Mexico reported a lower quality of family planning services compared with young adult women. Continued research and policies are needed to improve the quality of contraceptive services.

Contraceptive and sterilization practices and extrauterine pregnancy: a realistic perspective.

Comparative data on the incidence of ectopic pregnancy among accidental pregnancies associated with failure of a contraceptive or sterilization procedure are shown in Table 16. The practical clinical significance of the data in this review is predicated upon a number of related factors. One of the most important of these is the realistic failure rate (or success rate) of each contraceptive or sterilization method. The reported efficacy of various contraceptive methods has such a wide range that we have not attempted to calculate the likelihood that a woman may experience an ectopic pregnancy within a particular time period while using a specific method. The success or failure rate of each method is influenced by such variables as (1) the conscientiousness and ability of the patient to follow instructions, (2) the true failure rate of the method itself, (3) the experience of the clinician prescribing a method or performing a surgical procedure, and (4) other factors less clearly defined. Because of these many variables, the data shown in Table 16 were calculated on the basis of the number of reported accidental pregnancies which occurred coincidentally with, or subsequent to, a specific contraceptive or sterilization modality. (formula: see text). These data do not reflect the actual rate of occurrence of ectopic pregnancy with respect to woman-months of experience. We recognize the significant influence that age, race, gravidity, and socioeconomic factors have upon the incidence of ectopic pregnancy, but were unable to control for these factors in the data presented in this review. These data reprresent only what has occurred under specific circumstances and cannot logically be extrapolated to any specific future case or study series. It is important to emphasize the necessity of constant awareness by the medical and paraprofessional personnel of the potentially increased risk to the patient of an extrauterine pregnancy should one or another of these contraceptive or sterilization procedures fail. Complacency or a false sense of security on the part of responsible medical personnel concerning women who are "protected against conception" can quickly lead to a life-threatening situation in case of an ectopic pregnancy. Prompt diagnosis and definitive treatment of the extrauterine pregnancy is vital for the successful management of this serious complication of conception.

Recent declining trend in ectopic pregnancy in France: evidence of two clinicoepidemiologic entities.

OBJECTIVE: To assess the recent incidence of ectopic pregnancy (EP) in France (1992-1997) and to relate this incidence to trends in risk factors and use of contraception. DESIGN: Population register-based study. SETTING: Auvergne EP register (central France). PATIENT(S): Women aged 15-44 years with EP in the Auvergne region. MAIN OUTCOME MEASURE(S): Rates of EP, frequencies of exposure to risk factors, and sales of contraceptive methods in 1992-1997. RESULT(S): The overall EP rate decreased 13.7%, from 96.4 per 100,000 women aged 15-44 in 1992 to 83.2 per 100,000 in 1997. The rate of EP associated with reproductive failure remained stable, but the rate of EP associated with contraceptive failure (mostly intrauterine device failure) decreased 26.6%. The trends in the prevalence of the main risk factors for EP and sales of contraceptive methods are concordant with the changes in EP rates: Risk factor prevalence did not change over time, but intrauterine device sales in the area declined in parallel. CONCLUSION(S): The rates of EP as the result of contraceptive failure and as a result of reproductive failure evolve differently in the population and should not be confused in epidemiologic studies. This finding, along with published evidence that the two types of EP have different risk factors, location, prognosis, and perception by women, indicates that they are two distinct clinical entities possibly requiring different management.

Challenging the stereotypes: men, withdrawal, and reproductive health in Lebanon.

In Lebanon, coitus interruptus or withdrawal remains a widely practiced method of family planning. Our research sought to understand the role of men in reproductive health in Lebanon by focusing on this common practice. Our main questions were: Why is it that the practice persists when more effective modern methods of family planning are available? How is the decision taken to practice withdrawal? When is withdrawal practiced and with whom? And, finally, does the practice of withdrawal affect sexual pleasure and the sexual relationship more generally?To answer these questions, we embarked on a small exploratory study using in-depth interviews with 16 open-ended questions. We found that the most important reason for the continuing practice of withdrawal is fear of side effects from other methods. Men and women expect pleasure and fulfillment in sexual relations, but they are willing to limit their pleasure to limit their fertility by means they consider safe. No one prototypical practice of withdrawal seems to exist, and this may explain whether or not the method fails to prevent pregnancy.

Microbiological and histological findings in the fallopian tubes of women using various contraceptive methods.

The oviducts of seventy-three women undergoing sterilization by partial salpingectomy were submitted for microbiological and histologic studies. Twenty women were intrauterine device users, twenty-five women were oral contraceptive pill users and twenty-eight women used natural or barrier methods of contraception. Among intrauterine device users, there was an excess of mild and severe acute inflammatory histologic changes involving both the lumen and the tubal mucosa. Five of the eight intrauterine device users with acute inflammatory change had sterile tubal cultures.

PIP: The oviducts of 7o women undergoing sterilization by partial salpingectomy were subjected to microbiologic and histologic study. The objective was to determine whether there is a link between the histologic evidence of salpingitis and microbiological findings in the fallopian tubes of IUD users. Of the 73 subjects, 20 had been IUD users, 25 used oral contraceptives (OCs), and 28 were natural or barrier mehtod users. Microscopic examination revealed no significant differences between user groups with respect to edema, fibrosis, chronic inflammation, or granulomatous inflammation. However, acute inflammatory cells were found in the lumen and the mucosa of the right or left tube in an excess of IUD users. 5 of the 8 IUD users with acute inflammatory change had sterile tubal cultures. There were no differences between user groups with respect to the microbiologic organisms found in cervical or oviductal cultures, supporting the concept that inflammatory changes do not necessarily reflect the presence of infection. Further studies of the links between IUD use, sterile acute inflammation, and pelvic infection are recommended.

Barrier methods of contraception and the risk of cervical neoplasia.

The relationship between the use of barrier contraception methods and the risk of cervical neoplasia was analyzed using data from a case-control study conducted in the greater Milan area, northern Italy. A total of 367 cases of invasive cancer under 60 years of age were compared with 323 subjects in hospital for acute conditions unrelated to any of the established or suspected risk factors for cervical cancer, and 316 cases of cervical intraepithelial neoplasia were compared with 258 outpatient controls. Ever-use of barrier methods (condom and diaphragm) was reported by 6% of the cases of invasive cancer and 12% of hospital controls. Corresponding values for intraepithelial neoplasia were 16% for cases and 22% for outpatient controls. Considering the total use of barrier methods, compared to never use, the relative risk of invasive cervical cancer was 0.4 (95% confidence interval 0.2-0.9) and decreased with duration of use (chi 2(1), trend = 5.18, p = 0.02). Likewise, use of barrier methods lowered the risk of intraepithelial neoplasia; the estimated relative risks were 0.9 in users for less than two years and 0.6 for two or more (chi 2(1), trend = 4.61, p = 0.03). Although the protection for invasive cancer appeared to be greater at older ages and in multiparous women, the relative risks were not significantly heterogeneous in various strata of parity, number of sexual partners, oral contraceptive use and history of Pap smears.

PIP: The relationship between the use of barrier contraception methods and the risk of cervical neoplasia was analyzed using data from a case-control study conducted in the greater Milan area, northern Italy. A total of 367 cases of invasive cancer under 60 years of age were compared with 323 subjects in hospital for acute conditions unrelated to any of the established or suspected risk factors for cervical cancer, and 316 cases of cervical intraepithelial neoplasia were compared with 258 outpatient controls. Ever-use of barrier methods (condom and diaphragm) was reported by 6% of the cases of invasive cancer and 12% of hospital controls. Corresponding values for intraepithelial neoplasia were 16% for cases and 22% for outpatient controls. Considering the total use of barrier methods, compared to never use, the relative risk of invasive, cervical cancer was 0.4 (95% confidence interval 0.2-0.9) and decreased with duration of use (x squared 1 trend= 5.18, p=0.02). Likewise, use of barrier methods lowered the risk of intraepithelial neoplasia; the estimated relative risks were 0.9 in users for 2 years and 0.6 for 2 or more (X squared 1 trend= 4.61, p=0.03). Although the protection for invasive cancer appeared to be greater at older ages and in multiparous women, the relative risks were not significantly heterogeneous in various strata of parity, number of sexual partners, oral contraceptive use and history of Pap smears. (Author's).

Fertility following discontinuation of different methods of fertility control.

The possibility of permanent sterility following use of modern contraceptive agents is a concept which causes great concern amongst members of the lay public. However, a thorough review of the literature gives a great deal of reassurance on this topic. The combined oral contraceptive pill causes slight delay, and the injectable contraceptives a moderate delay in the return of fertility following discontinuation, but there is no evidence of a greater likelihood of permanent infertility than in the normal population. The progestogen-only minipill should be risk-free, but final data are lacking. Epidemiological studies do not indicate an increased risk of infertility following IUD use, but it seems likely that there must be a very small number of IUD users who develop permanent infective damage to the Fallopian tubes. Barrier methods and periodic abstinence probably do not have any significant effect on subsequent fertility. Barrier methods could be protective. Therapeutic abortion may have a small deleterious effect on long-term reproductive success, but the data are inconclusive. Detailed information on fertility following use of other methods is not available.