Uma revisão integrativa a respeito de métodos contraceptivos / An integrative review on contraceptive methods / Una revisión integrativa de los métodos anticonceptivos

Os métodos contraceptivos desempenham um papel vital na saúde sexual e reprodutiva, oferecendo opções que permitem o planejamento familiar e a prevenção de gravidezes indesejadas. Este artigo busca descrever os benefícios e desvantagens dos principais anticoncepcionais presentes na atualidade por meio de uma revisão integrativa da literatura, que buscou identificar os achados científicos publicados nos últimos 10 anos (2013 a fevereiro de 2023). A seleção de artigos foi feita nas bases eletrônicas de dados da PubMed, BVS, SciELO e no Google Acadêmico. Para a realização da revisão integrativa foi estabelecida a pergunta norteadora, para possibilitar a busca na base dados: Quais os benefícios e as desvantagens dos anticoncepcionais adesivo combinado, anel vaginal, sistema intrauterino de liberação de Levonorgestrel (SIU-LNG), contracepção de emergência (pílula de emergência), implante hormonal e anticoncepcional oral (ACO). Um dos pontos mais notáveis nesta revisão foi a grande variedade de métodos contraceptivos e suas peculiaridades, que se adequam à necessidade da usuária, sendo, portanto, preciso uma análise cuidadosa do método a ser escolhido. Outro ponto de destaque, foi que apesar dos benefícios dos contraceptivos, também estão presentes os efeitos adversos e possíveis complicações, além das precauções em sua utilização.

Contraceptive methods play a vital role in sexual and reproductive health, offering options that allow for family planning and the prevention of unwanted pregnancies. This article seeks to describe the benefits and disadvantages of the main contraceptives currently available through an integrative literature review, which sought to identify scientific findings published in the last 10 years (2013 to February 2023). The selection of articles was made in the electronic databases of PubMed, VHL, SciELO and Google Scholar. To carry out the integrative review, the guiding question was established, to enable the search in the database: What are the benefits and disadvantages of contraceptives combined patch, vaginal ring, Levonorgestrel-releasing intrauterine system (LNG-IUS), emergency contraception (emergency pill), hormonal implant and oral contraceptive (OC). One of the most notable points in this review was the wide variety of contraceptive methods and their peculiarities, which adapt to the user's needs, therefore requiring a careful analysis of the method to be chosen. Another highlight was that despite the benefits of contraceptives, adverse effects and possible complications are also present, in addition to precautions in their use.

Los métodos anticonceptivos desempeñan un papel vital en la salud sexual y reproductiva, ofreciendo opciones que permiten la planificación familiar y la prevención de embarazos no deseados. Este artículo busca describir los beneficios y desventajas de los principales anticonceptivos actualmente disponibles a través de una revisión integrativa de la literatura, que buscó identificar hallazgos científicos publicados en los últimos 10 años (2013 a febrero de 2023). La selección de artículos se realizó en las bases de datos electrónicas PubMed, BVS, SciELO y Google Scholar. Para realizar la revisión integradora se estableció la pregunta orientadora, para posibilitar la búsqueda en la base de datos: Cuáles son los beneficios y desventajas de los anticonceptivos combinados parche, anillo vaginal, sistema intrauterino liberador de levonorgestrel (SIU-LNG), anticoncepción de emergencia (emergencia píldora), implante hormonal y anticonceptivo oral (AO). Uno de los puntos más destacables de esta revisión fue la gran variedade de métodos anticonceptivos y sus peculiaridades, que se adaptan a las necesidades del usuario, requiriendo por tanto un análisis cuidadoso del método a elegir. Otro destaque fue que a pesar de los beneficios de los anticonceptivos, también están presentes efectos adversos y posibles complicaciones, además de precauciones en su uso.

Eficacia y seguridad del uso extendido de anticonceptivos orales combinados / Efficacy and safety of extended use of combined oral contraceptives

Los anticonceptivos orales combinados constituyen hoy en día uno de los métodos anticonceptivos más populares a nivel mundial. Su composición consiste en una combinación de análogos de hormonas sexuales femeninas que se administran en bajas dosis diarias, manteniendo constante su concentración sanguínea y evitando de esta forma los cambios en el eje endócrino que estimulan la ovulación. Con el objetivo de recrear los procesos fisiológicos, la mayoría de las formulaciones comprenden un intervalo de 4 a 7 días libres de hormonas en el cual se genera el sangrado por deprivación.A partir de una viñeta clínica en la que una paciente sana desea posponer su hemorragia por deprivación, y tras realizar una búsqueda bibliográfica que prioriza las investigaciones más recientes y de mejor calidad, la autora revisa la evidencia sobre el uso de hormonas sin intervalo libre, especialmente su efectos sobre la eficacia y la incidencia de efectos adversos. (AU)

Nowadays, combined oral contraceptives are one of the most popular contraceptive methods worldwide. Its composition consists of a combination of similar female sex hormones administered in low daily doses, keeping their blood concentration constant and thus avoiding changes in the endocrine axis that stimulate ovulation. In order to recreate physiological processes, most formulations include an interval of 4 to 7 hormone-free days in which withdrawal bleeding occurs.Starting from a clinical vignette in which a healthy patient desires to postpone her withdrawal bleeding, and after conducting a bibliographic search that prioritizes the most recent and best-quality research, the author reviews the evidence about the use of hormones without free interval, especially their effects on efficacy and the incidence of adverse effects. (AU)

Fallo en la regulación de la fertilidad posparto en mujeres en vulnerabilidad social en Colombia / Failured to regulate postpartum fertility in vulnerable women in Colombia

Objetivo: Evaluar la prevalencia de fallo en la regulación de la fertilidad posparto y la asociación con otros factores en un municipio colombiano (2017). Método: Estudio observacional de corte transversal con 148 mujeres. Se aplicó un muestreo no aleatorio para incluir mujeres que hubieran tenido un parto en los últimos 5 años. Se calcularon la prevalencia y las razones de prevalencia. Se exploró la asociación con la prueba χ2 o la prueba exacta de Fisher bajo una significancia estadística de 0,05. Resultados: Se encontró una prevalencia de fallo de la regulación de la fertilidad posparto del 40,5%. La prevalencia se asoció con ejercer oficios del hogar, tener uno o dos hijos, no planificar o no acceder a métodos de planificación y haber tenido un embarazo con periodo intergenésico menor de 2 años (p < 0,05). Conclusiones: Es necesario implementar estrategias para identificar barreras de acceso a la planificación, impactando en el espaciamiento entre embarazos y el acceso a los servicios. Lo anterior para generar múltiples beneficios para la madre, su hijo/a, el sistema de salud y la sociedad.

Objective: To evaluate the prevalence of regulated postpartum fertility failure and possible associated factors in a Colombian municipality (2017). Method: Cross-sectional observational study of 148 women. A non-random sampling method was used to include women who had given birth to a child in the last five years. Prevalence and prevalence ratios were calculated. Associations were examined at 0.05 statistical significance using χ2 test or Fishers exact test. Results: The prevalence of postpartum fertility failure was found to be 40.5%. The prevalence was associated with household work, having one or two children, not planning, or not having access to planning methods, and having a pregnancy with an interval between pregnancies of less than 2 years (p < 0.05). Conclusions: It is necessary to implement strategies to identify barriers to access to planning, which have an impact on the spacing between pregnancies and access to services. This will have multiple benefits for mother, child, health system and society.

Uso de anticonceptivos de emergencia y percepción sobre sus perjuicios en estudiantes universitarias colombianas / Use of emergency contraception and knowledge about its harms on Colombian female university students i: en

Introducción: La educación sexual y reproductiva puede prevenir o reducir cualquier daño físico o mental, o ambos, ocasionado por las prácticas sexuales de riesgo y el uso inadecuado de métodos anticonceptivos. Objetivo: Describir el uso de anticonceptivos de emergencia en estudiantes universitarias y la percepción de estas en cuanto a los perjuicios de dichos métodos para la salud. Métodos: Se efectuó un estudio descriptivo y transversal, de abril a octubre de 2021, de 372 féminas mayores de 18 años de edad, matriculadas en universidades ubicadas en Medellín, Colombia, quienes fueron seleccionadas mediante un muestreo no probabilístico. La información se obtuvo a través de una encuesta, en la cual se incluyeron variables relacionadas con el empleo de los anticonceptivos de emergencia y la percepción sobre sus perjuicios. Resultados: En la serie, 67,7 % de las jóvenes había usado anticonceptivos de emergencia, de las cuales 8,7 % refirió consumir hasta 3 píldoras de levonorgestrel al mes y 0,8 %, más de 10 durante un año; en tanto, 97,8 % consideró que este tipo de método afecta la salud. Entre los principales efectos secundarios figuraron los sangrados irregulares (65,8 %), las náuseas (31,7 %), los vómitos (31,7 %), la migraña (3,2 %) y los cambios de ánimo (25,4 %). Conclusiones: Aunque la mayoría de las estudiantes universitarias que usaban anticonceptivos de emergencia se guiaban por las recomendaciones médicas, un pequeño grupo lo hacía de manera inadecuada, lo cual se asoció a una baja percepción sobre los perjuicios de este método para la salud.

Introduction: Sexual and reproductive education can prevent or reduce any physical or mental harm, or both, caused by risky sexual practices and inadequate use of contraceptive methods. Objective: To describe the use of emergency contraception among female university students and their awareness regarding the harms of these methods for their health. Methods: A descriptive and cross-sectional study was conducted, from April to October 2021, of 372 women over 18 years of age, enrolled in universities located in Medellin, Colombia, who were selected through non-probabilistic sampling. The information was obtained through a survey, which included variables related to the use of emergency contraception and the awareness of its harms. Results: In the series, 67.7% of the young women had used emergency contraceptives, of whom 8.7% reported consuming up to 3 levonorgestrel pills per month and 0.8% more than 10 during a year, while 97.8% considered that this type of method affects their health. Among the main adverse effects were irregular periods (65.8%), nausea (31.7%), vomiting (31.7%), migraine (3.2%) and mood changes (25.4%). Conclusions: Although most of female university students who used emergency contraceptives were guided by medical recommendations, a small group did so inappropriately, which was associated with a low perception of the health harms of this method.

O uso dos métodos anticoncepcionais por estudantes de Medicina: uma revisão narrativa / Medical students' use of contraceptive methods: a narrative review

Anticoncepção são todas as técnicas e métodos utilizados para evitar a concepção. Os estudantes de Medicina se destacam nesse contexto, por representarem uma população em um período no qual a gravidez e doenças sexualmente transmissíveis são emergenciais. Logo, este estudo analisou a eficácia dos métodos contraceptivos na comunidade acadêmica médica e verificou se há ou não diferença na taxa de eficácia, em comparação com a população em geral. Sendo assim, realizou- -se uma revisão narrativa e encontraram-se 2.182 artigos; desses, 1.513 cumpriram o critério de inclusão, porém somente quatro artigos atendiam a todos os critérios e foram utilizados. A conclusão do estudo foi de que a taxa de Pearl é maior na população estudada devido ao mau uso dos contraceptivos, necessitando da melhora na qualidade da educação sexual nas universidades de Medicina ao redor do mundo, a fim de se evitarem a perpetuação da má utilização de contraceptivos e a desinformação no meio acadêmico médico.

Contraception is all the techniques and methods that are used to prevent conception. Medical students stand out in this context because they represent a population in a period in which pregnancy and sexually transmitted diseases are emergencies. Therefore, this study analyzed the effectiveness of contraceptive methods in the medical academic community and verified whether or not there is difference in the rate of effectiveness compared to the general population. A narrative review was conducted and 2,182 articles were found, of these 1,513 met the inclusion criteria, but only four articles met all the criteria and were used. The conclusion of the study was that Pearl's rate is lower in the studied population due to the misuse of contraceptives, requiring improvement in the quality of sex education in medical universities around the world in order to avoid perpetuation of misuse of contraceptives and misinformation in the medical academic environment.

Indications and reasons for discontinuing the levonorgestrel-releasing intrauterine system (LNG-IUS) / Indicações e razões para descontinuação do sistema intra-uterino liberador de levanogestrel (SIU-LNG)

Abstract Objectives: to identify the main indications and reasons for discontinuing the use of the Levonorgestrel-Releasing Intrauterine System (LNG-IUS). Methods: a cross-sectional study was carried out from medical records of 327 women who used the LNG-IUS 52mg between January 2011 and December 2016 at a public hospital in the Northeast of Brazil. Results: the main indications for the use of the LNG-IUS were: contraception (32.7%), myoma/metrorrhagia (28.7%) and endometriosis/pelvic pain (22.3%). Of the 327 women, 68 (20.8%) had discontinued using the device. The most frequent reasons for discontinuation were: expulsion (9.2%), LNG-IUS expiration (3.7%), bleeding (2.4%) and pain (1.5%). Most patients had no difficulty in the insertion and did not require anesthesia/sedation. Among the 30 women who expelled the device, 17 (56.7%) had used it for metrorrhagia and myoma, 8 (26.7%) for contraception, and 5 (16.6%) for endometriosis/pelvic pain. Conclusions: the LNG-IUS is a well-accepted contraceptive method, with therapeutic applications for some gynecological conditions and a low expulsion rate.

Resumo Objetivos: identificar as principais indicações e razões para a descontinuação do uso do sistema intra-uterino liberador de levanogestrel (SIU-LNG). Métodos: foi realizado um estudo transversal a partir de prontuários de 327 mulheres que usaram o SIU-LNG 52mg entre janeiro de 2011 e dezembro de 2016 em um hospital público do Nordeste do Brasil. Resultados: as principais indicações para o uso do SIU-LNG foram: contracepção (32,7%), mioma / metrorragia (28,7%) e endometriose / dor pélvica (22,3%). Das 327 mulheres, 68 (20,8%) haviam descontinuado o uso do dispositivo. Os motivos mais frequentes de descontinuação foram: expulsão (9,2%), expiração de SIU-LNG (3,7%), sangramento (2,4%) e dor (1,5%). Conclusão: a maioria dos pacientes não teve dificuldade na inserção e não necessitou de anestesia / sedação. Entre as 30 mulheres que expulsaram o dispositivo, 17 (56,7%) o utilizaram para metrorragia e mioma, 8 (26,7%) para contracepção e 5 (16,6%) para endometriose / dor pélvica. O SIU-LNG é um método contraceptivo bem aceito, com aplicações terapêuticas para algumas condições ginecológicas e baixa taxa de expulsão.

Post-abortion contraception before hospital discharge after installation of a surveillance network in Brazil.

OBJECTIVE: To evaluate the use of contraception soon after abortion, ectopic, or molar pregnancy following the establishment of a surveillance network (MUSA). METHODS: A cross-sectional study of women admitted for abortion, or ectopic or molar pregnancy at UNICAMP Women's Hospital (part of the MUSA Network), Campinas, Brazil, between July 2017 and August 2019. Clinical and sociodemographic data were compared between women who initiated contraception before discharge and those who did not by using a Cochran-Armitage test and multiple logistic regression. RESULTS: Overall, 382 women were enrolled (mean ± SD age, 29.6 ± 7.4 years). Most women (287, 75.2%) had abortions, and 146 (38.2%) initiated contraception before hospital discharge. The most common contraceptives were injectables (75, 51.4%) followed by pills (65, 44.5%). Use of contraception increased during the study period (Z=3.69, P<0.01), mostly due to injectables (Z=3.84, P<0.01). Factors independently associated with contraceptive initiation were admission in 2019 (odds ratio [OR], 2.65; 95% confidence interval [CI], 1.36-5.17) and not having an abortion for legal reasons (OR, 3.54; 95% CI, 1.30-9.62). CONCLUSION: Implementation of a surveillance network optimized the health service and quality of care. There was an increase in contraception use and a vulnerable population was identified.

Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.

OBJECTIVE: Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. STUDY DESIGN: This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use. RESULTS: For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001). CONCLUSION: Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®. IMPLICATIONS: WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.

Pregnancy rates among Chilean women who had non-surgical sterilization with quinacrine pellets between 1977 and 1989.

We describe cumulative pregnancy probabilities among women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N = 1492). We interviewed the women or relatives in 1991-93 and 1994-96, and reviewed hospital records. Mean follow-up was 9.6 years (median 9 years). We recorded 120 pregnancies, including 40 that went to term or near-term. There were nine adverse outcomes in eight infants: one fetal death at 18 weeks gestation; three infants born prematurely; one stillbirth (placental infarct); and four infants with birth defects. There was no clustering of any particular kind of birth defect. For two insertions, the 10-year cumulative pregnancy probability was 8.9 (95% confidence interval 3. 7, 14.1). For 3 insertions, the 10-year rate was 7.0 (4.4, 9.5). For women who were under 35 years at insertion, the 10-year rate was 10. 7 (7.4, 14.1). For women who were 35 or older at insertion, the 10-year rate was 3.1 (0.6, 5.7). The pregnancy rate varied little for 2 vs. three insertions, but the rate did vary significantly by age, with women who received quinacrine at 35 years or older 0.3 (0. 2, 0.5) times as likely to become pregnant as younger women. The 10-year cumulative ectopic pregnancy probabilities for women with two and three insertions of quinacrine were 0.9 (<0.1, 2.6) and 0.5 (<0.1, 1.2), respectively. Pregnancy rates after quinacrine insertion are higher than after surgical sterilization, but ectopic pregnancy rates appear similar.

Mesigyna once-a-month combined injectable contraceptive: experience in Latin America.

A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.

Efficacy, acceptability, and clinical effects of a low-dose injectable contraceptive combination of dihydroxyprogesterone acetophenide and estradiol enanthate.

A total of 1,904 women, aged 15-38, used an injectable contraceptive combination of 90 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate, given once during each menstrual cycle between the 7th and 10th day, and preferably on the 8th day of the cycle, for a total of 17,576 cycles. Of these 1,904 women, 1,197 completed 12 cycles of use of the injectable combination. One subject became pregnant during the trial, resulting in a cumulative pregnancy rate of 0.07%. Principal reasons for discontinuation were personal, non-medical reasons, such as lost to follow-up, no longer wished to continue, protocol violation, desire to change to another contraceptive method, moved away, or other personal reasons. Mean weight of 1,901 subjects at admission to the trial was 53.5 +/- 0.2 kg and this increased to 54.3 +/- 0.3 kg after 12 cycles of use. Approximately 50% of subjects experienced menstrual bleeding similar to normal throughout the study period. The most frequent menstrual abnormality was irregular bleeding, experienced by approximately one-third of subjects.

New data show Norplant effective for 7 years.

PIP: According to research conducted in Chile, the Dominican Republic, Egypt, Finland, Singapore, Thailand, and the US, the levonorgestrel contraceptive implant Norplant offers up to 7 years of effective protection from pregnancy. The research involved two independent studies of 1210 women aged 18-40 in the seven countries using soft-tubing as well as hard-tubing Norplant implants. Overall, results indicated that cumulative 7-year pregnancy rates among Norplant users are comparable to rates among women who have been surgically sterilized. Moreover, among women ages 18-33 the 7-year Norplant pregnancy rates are comparable to the median rates of tubal sterilization methods for women of the same age and duration of use. For women ages 34 and older, without regard to weight at admission, the 7-year effectiveness of soft-tubing Norplant equals or surpasses that of tubal sterilization.^ieng

Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women.

The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/L from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of four PVRs. No pregnancies occurred in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

PIP: This study compares the contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile and a Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers used the PVR and 262 used T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/l from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of 4 PVRs. There were no pregnancies in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were seen in the PVR group. Breast-feeding performance and infant growth were similar in both groups. These results prove the high efficacy and safety of the PVR for nursing women. This has led to the registration of the PVR by Chilean health authorities.

Timing of onset of contraceptive effectiveness in Depo-Provera users. II. Effects on ovarian function.

OBJECTIVE: To determine the timing of onset of contraceptive effectiveness after the first injection of 150 mg of depot medroxyprogesterone acetate (DMPA) administered between days 8 and 13 of the menstrual cycle. DESIGN: Descriptive, prospective study. SETTING: A tertiary university referral center. PATIENT(S): Thirty healthy women between 18 and 40 years of age. INTERVENTION: Volunteers were injected with DMPA between days 8 and 13 (5 women on each day) of the menstrual cycle. MAIN OUTCOME MEASURE(S): Ovarian function determined by serum levels of E2 and progesterone and follicular development evaluated by vaginal ultrasound. RESULT(S): In nine (30%) of 30 women studied, DMPA did not prevent ovulation. All ovulations occurred in women receiving DMPA between days 10 and 13 of the cycle. No woman who received injections on day 8 or 9 ovulated. Ovulation suppression was more effective in women with low ovarian activity. All ovulation occurred within 3 days after the injection. CONCLUSION: A back-up contraceptive method, used after the 7th day of the menstrual cycle, is recommended for up to 7 days after the first injection of DMPA.

PIP: To ensure ovulation does not occur, it is recommended that Depo-Provera injections be administered within the first 7 days of the menstrual cycle. In some settings, this requirement acts as a barrier to women's free access to injectable contraception. Thus, the present study investigated the timing of onset of contraceptive effectiveness when the first injection of depot medroxyprogesterone acetate is administered between days 8-13 of the menstrual cycle. 30 women 18-40 years of age attending a university referral center in Campinas, Brazil, in 1995-96, were enrolled. Ovulation, detected through serum progesterone and estradiol assays and confirmed by follicle rupture at vaginal ultrasound, occurred in 9 cases (30%). No ovulations occurred when injection was administered on day 8 (n = 5) or day 9 (n = 5) of the menstrual cycle; only 1 of the 5 women treated on day 10 ovulated. On the other hand, 4 of the 10 women treated on days 11 and 12 and 4 of the 5 injected on day 13 showed evidence of ovulation. All ovulation occurred within 3 days after injection. Ovulation occurred only among women who had serum estradiol levels of 100 pg/ml and above and a leading follicle diameter greater than 13 mm at the time of injection. Ovulation suppression was more effective in women with low ovarian activity. A back-up contraceptive method used for 4 days after Depo-Provera injection should provide sufficient protection when the method is administered after day 7 of the menstrual cycle. However, given the uncertainty of the assumption of short viability of the human oocyte, it is safer to recommend 1 week's use of a back-up method or abstinence.

Introduction of cyclofem once-a-month injectable contraceptive in Mexico.

A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.

PIP: The effectiveness and continuation rates associated with the once-a-month injectable contraceptive Cyclofem were investigated in an introductory trial conducted in three Mexican provinces (Sinaloa, Guanajuato, and Veracruz). Cyclofem contains 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate. A total of 3457 women (640 women from rural communities and 2817 from urban and suburban family planning centers) were enrolled and 20,316 woman-months of treatment experience were accumulated during the 12-month study period. The mean age of study participants was 23.6 years; 70% had previously used at least one contraceptive method. There was only one pregnancy (rate, 0.03%). The overall life-table continuation rate at 1 year was 26.1%, but this rate was higher in the community-based group (36.9%) than in the health center group (22.4%). This discrepancy is presumed to reflect the greater access of clinic clients to other contraception options. Continuation was highest among women 30-34 years of age, those with low levels of education, women with five or more children, and those who did not want more children. Only 14% of discontinuations were method-related. The 1-year discontinuation rate for bleeding problems, including amenorrhea, was 10.2%. These findings indicate Cyclofem is a safe, effective method appropriate for inclusion in Mexico's Ministry of Health Family Planning Program.

Contraception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic.

A 5-year trial of a two-rod contraceptive implant, which releases the progestin levonorgestrel (LNG rod), was conducted at four clinics with 594 women. Mean age and weight at admission were 25.5 years and 62.4 kg, respectively. Consent to continue through 5 years was sought and obtained when the 3-year cumulative pregnancy rate proved to be 0.8 per 100. No pregnancies occurred in the fourth or fifth years. The 5-year cumulative pregnancy rate was, therefore, 0.8 per 100 with an annual average pregnancy rate below 2 per 1000 women. Prolonged bleeding/spotting (8.2% of subjects) and irregular bleeding (5.6%) were the most frequently cited medical reasons for removal. Removals for headache (4.7%) and weight change (4.0%) were the next most frequent medical reasons. Between 1% and 2% of subjects during the 5-year trial sought removals for each of the following conditions: mood changes, lower abdominal pain, depression, or pain at the implant site. The mean annual continuation rate during the study was 77 per 100. Use per woman averaged 2.96 years. Mean removal time was 5.9 +/- 0.6 min. These data indicate that, for a 5-year period, the two LNG rod implants are equivalent to the six Norplant capsule implants with respect to safety and efficacy parameters, but permit easier and more rapid implant removal.

PIP: The newly developed 2-rod levonorgestrel (LNG) implant system has a surface area only 44% that of Norplant yet provides LNG release rates and blood levels similar to the 6-capsule Norplant system. Clinical trials of the 2-rod implant system initiated in 1990 demonstrated an exceptionally low cumulative pregnancy rate (0.8/100) in the first 3 years of use. This paper reports on an extension of the original study for an additional 2 years. 594 women at 4 study sites in the US and the Dominican Republic completed 5 years of method use. No pregnancies occurred in the fourth and fifth years of use. Thus, the 5-year cumulative pregnancy rate was 0.8/100, with an average annual pregnancy rate below 2/1000 women. The mean annual continuation rate during the 5-year study period was 77/100 women, with an average duration of use of 2.96 years. The most frequent reasons for medical removal were prolonged bleeding/spotting (8.2% of women), irregular bleeding (5.6%), headache (4.7%), and weight gain (4.0%). Mean removal time was 5.9 minutes and complications occurred in only 2.3% of removals. Overall, these findings confirm that the 2-rod LNG implant contraceptive has an effectiveness equivalent to the 6-capsule implant for a 5-year period, with good acceptability and a substantially improved ease of removal.

Introductory study of the once-a-month, injectable contraceptive Cyclofem in Brazil, Chile, Colombia, and Peru.

An introductory trial with the injectable contraceptive Cyclofem was carried out in Brazil, Chile, Colombia, and Peru, with participation by 3,183 women. Women were followed-up for up to 2 years of use and the data were evaluated by life table analysis. A total of 29,676 women-months were accumulated for up to 2 years. No pregnancies were observed in the 2 years. The discontinuation rates for amenorrhea in the first year ranged from 3.4 in Brazil to 8.1 in Colombia, and for menstrual disturbances from 5.1 in Chile to 9.2 in Brazil. The discontinuation rates for other medical reasons ranged from 7.8 in Brazil to 26.3 in Colombia, and for personal reasons from 17.2 in Chile to 23.5 in Brazil. Continuation rates ranged from 42.3 in Colombia to 52 in Chile. In the second year of observation the rates of discontinuation were lower than those observed in the first year, with the exception of personal reasons in Brazil, which were the same as those observed in the first year. Continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. The comparison of reasons for discontinuation in selected clinics showed that the rate for amenorrhea in one clinic in Chile was more than three times that in others and in Peru was seven times more in one clinic than in another. Regarding menstrual disturbances, in Peru one clinic presented a rate three times higher than the others. The main reasons for discontinuation due to other medical reasons were headache and weight gain. In conclusion, Cyclofem presented a high contraceptive efficacy and an acceptable rate of continuation and discontinuation for up to 2 years in the four countries.

PIP: The performance of the monthly injectable contraceptive, Cyclofem, was evaluated in an introductory trial involving 3183 women recruited from family planning centers in Brazil, Chile, Colombia, and Peru. A total of 29,676 women-months of use were accumulated during up to 2 years of follow-up. No pregnancies occurred during the study period. Discontinuation rates per 100 women in the first year ranged from 3.4 in Brazil to 8.1 in Colombia for amenorrhea and from 5.1 in Chile to 9.2 in Brazil for menstrual disturbances. The discontinuation rate for other medical reasons (primarily headache, weight gain, and acne) ranged from 7.8 in Brazil to 26.3 in Colombia and for personal reasons from 17.2 in Chile to 23.5 in Brazil. First-year continuation rates ranged from 42.3 in Colombia to 52.0 in Chile. In the second year of use, continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. Upon receiving these results, national regulatory authorities in the 4 participating countries approved Cyclofem registration. Acceptance of injectable contraception, which currently entails administration of the method by a service provider and travel to a clinic, could be improved in developing countries by training in self-administration.

Can you bet your life on a condom?

PIP: A number of studies have demonstrated that when used consistently and correctly, both male and female condoms prevent unplanned pregnancy and the spread of sexually transmitted diseases (STDs). For example, in a study of US navy personnel who reported having vaginal intercourse with prostitutes who had a high prevalence of gonorrhea, none of the 29 men who reported using condoms during their sex acts contracted gonorrhea or nongonococcal urethritis. However, 14% of the 499 nonusers became infected. The preponderance of evidence from 10 studies of high-risk populations in 7 countries where both the level of condom use and HIV infection were prospectively measured showed the consistent use of male condoms to protect against HIV acquisition in the range of 50-100%. Additional evidence in support of condom use comes from two studies involving HIV-discordant couples. A European study of 123 such couples who consistently and correctly used condoms found that no HIV-uninfected partner became infected with HIV by their partners. Similarly, 1 of 42 seronegative partners in HIV-discordant couples in Haiti became infected with HIV after having consistently used condoms. In both of these studies, 7-14% of couples who used condoms either consistently or not at all became infected. Since the government of Thailand began promoting 100% condom use among prostitutes and their clients, there has been a decline in both the level of curable STDs reported to clinics and HIV prevalence among Thai military recruits. Male and female condoms are effective even under typical imperfect conditions, and their consistent use should be encouraged at every opportunity.^ieng

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Comparative study of safety and efficacy of IUD insertions by physicians and nursing personnel in Brazil.

To assess whether trained nursing personnel could provide IUD services as safely and effectively as physicians in Brazil, an experimental study was conducted at the main clinic of the Center for Research on Integrated Maternal and Child Care in Rio de Janeiro. From November 1984 through April 1986, a total of 1,711 women who requested IUD insertion at the clinic were randomly assigned to have a Copper-T 200 IUD inserted by one of the clinic's 11 physicians or 13 nurses. All of the physicians and nursing staff members who provided these services had taken the Center's standard clinical family planning training course. Of 860 insertions attempted by the physicians and nurses, 1.3% and 3.3%, respectively, were unsuccessful. Statistically, this difference was very significant (P < 0.01). Also, mainly because the cervix was small and undilated, nulliparous women had a relatively high insertion failure rate of 8.0%, as compared to 1.5% for primiparas and 1.0% for multiparas. The overall rate of complications at insertion was 1.8%, these complications including diaphoresis, vomiting, syncope, cervical laceration, and one case of perforation of the uterus; no significant difference was found between the complication rates for insertions performed by physicians as compared to nurses. However, 9.0% of the study subjects reported severe pain during IUD insertion, with significantly higher percentages reporting pain if the IUD was inserted by a physician, or if the subject was nulliparous, had preinsertion symptoms, or had a history of pelvic inflammatory disease (PID) or sexually transmitted disease (STD). It was also found that the nurses had a dramatically high insertion failure rate (11.6%) with nulliparous subjects, while the physicians' failure rate with such subjects was a significantly lower 3.4%. No significant difference was found in the groups served by nurses and physicians with regard to postinsertion complaints or termination of use within 12 months of insertion. These findings suggest that future training, besides preparing nursing personnel in IUD insertion, should emphasize preparation in taking the client's medical history and diagnosing existing medical symptoms that could be associated with IUD insertion complications. In addition, if a nulliparous woman requests an insertion, it should be performed by a physician or more experienced nursing staff member with close medical supervision. Because of high rates of reported pain at insertion, such women, as well as those with medical symptoms associated IUD insertion complications and those with a history of PID or STD, should be considered candidates for extra care and counseling.(ABSTRACT TRUNCATED AT 400 WORDS)

PIP: In the mid-1980s in Brazil, health workers randomly assigned 1711 women aged 15-48 requesting IUD insertion at the Center for Research on Integrated Maternal and Child Care clinic in Rio de Janeiro to have the Copper-T 200 IUD inserted by a physician or by a nurse. The study aimed to determine whether trained nurses could perform as safe and effective IUD insertions as physicians. Insertion failure was more common when performed by nurses than physicians (3.3% vs. 1.3%; p = 0.005). Severe pain at insertion was more common during physician insertions than nurse insertions (10.8% vs. 7.1%; p = 0.008) and in women who had menstrual bleeding, bleeding, dysmenorrhea, or pelvic pain than in women lacking these preinsertion symptoms (14.2% vs. 7.8%; p 0.001). History of pelvic inflammatory disease (PID) or a sexually transmitted disease (STD) increased the likelihood of severe pain at insertion (14.5% vs. 8.5%; p = 0.022). Nulliparous women were more likely to experience insertion failure than parous women regardless of provider, especially for nurse insertions (11.6% vs. 1.6%; p 0.01). The higher failure rate among nurses was probably due to a higher proportion of nulliparous women in the nurse insertion group (17.2% vs. 13.6%; p 0.05). The overall IUD use-effectiveness rate at 12 months was 98.8% (98.6% for physicians and 99% for nurses). The cumulative IUD continuation rate at 12 months was slightly better for nurse insertions than for physician insertions (75.2% vs. 74.4%). There were no significant differences between termination rates regardless of reason (pregnancy, expulsion, or removal) between physicians and nurses. The increases in complaint rates between preinsertion and postinsertion were the same for both physicians and nurses (25.8% and 25.1%, respectively). These results indicate the need to emphasize taking the client's medical history and diagnosing existing medical symptoms that are possibly linked to IUD insertion complications. Physicians or more experienced nurses should insert an IUD in nulliparous women. More counseling and care are needed for women with IUD insertion complications and those with a history of PID or STD.