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.

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.

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.

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.

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.

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.

Relationship characteristics and contraceptive use among young adults.

CONTEXT: Young adults have high rates of unintended childbearing and STDs, yet little research has examined the role of relationship characteristics in their contraceptive use. METHODS: Data collected from the 2002-2005 rounds of the National Longitudinal Survey of Youth yielded a sample of 4,014 dating relationships among sexually active 18-26-year-olds. Bivariate analysis and multivariate logistic and multinomial logistic regressions assessed associations between relationship characteristics and contraceptive use at last sex. RESULTS: In three-quarters of the relationships, respondents had used some method at last intercourse; respondents in 26% of the relationships had used a condom only, in 26% a hormonal method only and in 23% dual methods. Compared with respondents in relationships in which first sex occurred within two months of starting to date, those who first had sex before dating were more likely to have used any method at last sex (odds ratio, 1.4), particularly condoms or dual methods (relative risk ratio, 1.5 for each). The relative risk of using a hormonal method only, rather than no method or condoms only, increased with relationship duration (1.01) and level of intimacy (1.1-1.2). Discussing marriage or cohabitation was associated with reduced odds of having used any method (0.7) and a reduced relative risk of having used condoms alone or dual methods (0.6 for each). Increasing levels of partner conflict and asymmetry were also linked to reduced odds of any method use (0.97 and 0.90, respectively). CONCLUSIONS: Prevention programs should address relationship context in contraceptive decision making, perhaps by combining relationship and sex education curricula to foster communication and negotiation skills.

Hipertensión arterial y anovulatorios transdérmicos / Hypertension and the transdermal contraceptive patch

Entre las complicaciones de la anticoncepción hormonal destacan las cardiovasculares (doble riesgo de accidente cerebrovascular e infarto isquémico, y riesgo cuatro veces mayor de presentar complicaciones tromboembólicas). A pesar de que la aparición de hipertensión arterial (HTA) es poco frecuente, se han descrito casos de HTA acelerada acompañada de daño renal. Este efecto adverso se ha documentado en relación con los anticonceptivos orales y no se han encontrado en la literatura científica referencias al uso de anticonceptivos transdérmicos pese a la diferencia en su farmacodinamia. Presentamos el caso clínico de una paciente de 22 años que desarrolló HTA maligna con fallo renal tras sustituir anticonceptivos orales por vía transdérmica y que cedió al detener el tratamiento. Son necesarios más estudios para aclarar esta posible relación, pero este hecho aislado remarca la importancia de la recomendación sobre la toma de presión arterial como parámetro de control clínico de las usuarias de anticoncepción hormonal (AU)

Cardiovascular complications are one of the risks of hormonal contraception use (a two-fold risk of stroke and ischemic infarct and a four-fold risk of thromboembolic complications). Although the development of hypertension is infrequent, cases of accelerated hypertension accompanied by renal failure have been described. This adverse effect has been reported in relation to oral contraceptives but there are no references in the literature to the use of transdermal contraceptives, despite differences in the pharmacodynamics between the two routes of administration. We report the case of a 22-year-old woman who developed malignant hypertension with renal failure after replacing oral contraceptives for the transdermal patch. The hypertension resolved after discontinuing transdermal contraceptive use. Further studies are required to clarify this possible association but this isolated case highlights the importance of blood pressure measurement in the monitoring of hormonal contraception users (AU)

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.

Subserosal misplacement of Essure device manifested by late-onset acute pelvic pain.

OBJECTIVE: To increase awareness of the potential to present with late-onset acute pelvic pain secondary to subserosal misplacement of an Essure device (Conceptus Inc., Mountain View, CA). DESIGN: Case report. SETTING: University-affiliated teaching hospital. PATIENT(S): A 30-year-old woman who was seen with severe left lower quadrant pain 4 months after elective sterilization with an Essure device placed under local anesthesia. Mild to moderate resistance was encountered in the placement of the device in the left fallopian tube. INTERVENTION(S): Hysterosalpingogram showing patency of the left fallopian tube and operative laparoscopy. MAIN OUTCOME MEASURE(S): Laparoscopic removal of the Essure device with left salpingectomy. RESULT(S): The patient was free of pain and was discharged home the same day of the laparoscopic procedure. CONCLUSION(S): This report reinforces the need to consider a misplaced Essure device in the differential diagnosis of late-onset acute pelvic pain in women who had difficult placement of the device.

[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.

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.

Techniques for removal of the Essure hysteroscopic tubal occlusion device.

OBJECTIVE: To present two case reports of techniques for removal of the Essure (Conceptus, Inc., Mountain View, CA) hysteroscopic tubal occlusion device. DESIGN: Case report. SETTING: University-affiliated teaching hospital. PATIENT(S): Two women requesting removal of Essure devices because of persistent pelvic pain up to 6 weeks after placement. INTERVENTION(S): Hysteroscopic and laparoscopic removal of the Essure microinserts. No institutional review board approval was obtained because the procedures were not part of a study protocol. MAIN OUTCOME MEASURE(S): Effective removal of the Essure device and resolution of pelvic pain symptoms. RESULT(S): Successful removal of the device was achieved in both patients. In one case, the procedure was performed entirely by hysteroscopy. In the other case, a laparoscopic approach was required because of a lack of visualization of the device. Pain symptoms resolved within 2 weeks of removal in both patients. CONCLUSION(S): These are the first reported cases of successful removal of the Essure tubal occlusion devices up to 6 weeks after placement. This procedure can be safely performed with the use of hysteroscopy if the inserts are clearly visualized. Laparoscopy is an alternative when the device is completely within the fallopian tube. Further study is needed to assess the functionality of the tube after the procedure, as well as feasibility of removal beyond 6 weeks.

The rate of ectopic pregnancy for 24,589 quinacrine sterilization (QS) users compared to users of other methods and no method in 4 provinces in Vietnam, 1994-1996.

OBJECTIVE: To determine the rates of ectopic pregnancy with the use of quinacrine sterilization (QS) compared to other methods and no method (non-users). METHODS: Four provinces were selected for their above average numbers of women who had undergone QS: Nam Dinh, Nam Ha, Hai Duong and Hung Yen. Case histories related to surgical treatment of all ectopic pregnancies in these 4 provinces from 1994 through 1996 were collected from all hospitals by researchers from the Ministry of Health in June 1997. Using a questionnaire designed for this study, 120 physicians interviewed every woman in her home who had had an ectopic pregnancy during this period. If deceased, a family member was consulted. All interviews were completed in September 1998. The numbers of users of each method and nonusers were calculated from service statistics and demographic data. RESULTS: Based on 2,551,355 woman-years of exposure, the rate of ectopic pregnancy among users per 1000 woman-years was calculated to be: 0.26 with QS; 0.42 with surgical sterilization (TL) and IUD; 0.45 with the Pill; 0.50 with condoms; 0.78 relying on withdrawal; and 1.18 among non-users. CONCLUSION: Ectopic pregnancy rates for QS, TL, IUD and the Pill were similar and much lower than the rate for non-users of contraception.