Policies for expanding family planning coverage: lessons from five successful countries.

Background: Enhancing the design of family planning interventions is crucial for promoting gender equality and improving maternal and child health outcomes. We identified, critically appraised, and synthesized policies and strategies from five selected countries that successfully increased family planning coverage. Methods: We conducted a policy analysis through a scoping review and document search, focusing on documents published from 1950 to 2023 that examined or assessed policies aimed at enhancing family planning coverage in Brazil, Ecuador, Egypt, Ethiopia, and Rwanda. A search was conducted through PubMed, SCOPUS, and Web of Science. Government documents and conference proceedings were also critically analyzed. National health surveys were analyzed to estimate time trends in demand for family planning satisfied by modern methods (mDFPS) at the national level and by wealth. Changes in the method mix were also assessed. The findings of the studies were presented in a narrative synthesis. Findings: We selected 231 studies, in which 196 policies were identified. All countries started to endorse family planning in the 1960s, with the number of identified policies ranging between 21 in Ecuador and 52 in Ethiopia. Most of the policies exclusively targeted women and were related to supplying contraceptives and enhancing the quality of the services. Little focus was found on monitoring and evaluation of the policies implemented. Conclusion: Among the five selected countries, a multitude of actions were happening simultaneously, each with its own vigor and enthusiasm. Our findings highlight that these five countries were successful in increasing family planning coverage by implementing broader multi-sectoral policies and considering the diverse needs of the population, as well as the specific contextual factors at play. Successful policies require a nuanced consideration of how these policies align with each culture's framework, recognizing that both sociocultural norms and the impact of past public policies shape the current state of family planning.

Sociodemographic and reproductive risk factors associated with metabolic syndrome in a population of Brazilian women from the city of Ribeirão Preto: a cross-sectional study.

Objective: To identify sociodemographic and reproductive risk factors associated with MetS in women in their fourth decade of life. Methods: Cohort study conducted on women born from June 1978 to May 1979 in Ribeirão Preto, Brazil. Sociodemographic, clinical, and obstetric data were collected by interview and clinical evaluation. Univariable and multivariable binomial logistic regression models were constructed to identify the risk factors of metabolic syndrome and the adjusted relative risk (RR) was calculated. Results: The cohort included 916 women, and 286 (31.2%) of them have metabolic syndrome. MetS was associated with lack of paid work (RR 1.49; 95% CI 1.14-1.95), marital status of without a partner (RR 1.33; 95% CI 1.03-1.72), low educational level (less than 8 years of schooling [RR 1.72; 95% CI 1.23-2.41], 8 to 12 years of schooling [RR 1.37; 95% CI 1.06-1.76], when compared with more than 12 years of schooling), and teenage pregnancy (RR 2.00; 95% CI 1.45-2.77). There was no association between MetS, and the other covariates studied. Conclusion: Metabolic syndrome in a population of women in the fourth decade of life was associated with lack of employment, lack of a partner, low educational level, and teenage pregnancy.

Low doses of fluoxetine for the treatment of emotional premenstrual syndrome: a randomized double-blind, placebo-controlled, pilot study.

INTRODUCTION: The neuroactive metabolite of progesterone, allopregnanolone (ALLO), has been implicated in premenstrual syndrome (PMS) physiopathology and preclinical studies suggested that low doses of fluoxetine increase the ALLO brain concentration. OBJECTIVES: To assess which low dose of fluoxetine (2 mg/d, 5 mg/d or 10 mg/d), administered exclusively during the luteal phase of menstrual cycle, has a potential effect for preventing or mitigating emotional PMS symptoms. METHODS: In this randomized, double-blind, placebo-controlled pilot study, we followed 40 women (mean age = 29.7 +/- 7.4 years) with emotional PMS, during two menstrual cycles: cycle 1, without pharmacological intervention; and cycle 2, with pharmacological intervention. Participants took capsules, on average, seven days preceding the likely date of menses. We assessed the severity of PMS symptoms in both cycles using the Daily Record of Severity of Problems scale (DRSP). RESULTS: There was an increase in the DRSP scores during the late luteal phase of cycle 1, confirming the diagnosis of emotional PMS. Low doses of fluoxetine (5 mg/d: 33.5%; 10 mg/d: 48.4%) reduced DRSP total score in the day before menses (day-1) at cycle 2 compared with day-1 at cycle 1. Fluoxetine 10 mg/d had the most consistent decline in emotional PMS symptoms; 70% of the participants reported a reduction greater than 40% in the DRSP score. CONCLUSIONS: Low doses of fluoxetine, which may have no or few effect on the serotonergic system, but may interfere in the progesterone metabolization, seem to have some potential to mitigate emotional PMS symptoms. While the 10 mg/d of fluoxetine had the best performance on reducing emotional PMS symptoms, the 5 mg/d dose also seems to have some effect on emotional PMS symptoms. Further larger studies will help establish the lowest effective dose of flouxetine for PMS treatment.

Sociodemographic and reproductive risk factors associated with obesity in a population of brazilian women from the city of Ribeirão Preto: a cross-sectional study.

BACKGROUND: Obesity is a highly prevalent chronic disease that is associated with the development of other metabolic comorbidities. Its etiology is complex and multiple risk factors have been reported. In women, weight gain during pregnancy and the effect of pregnancy on subsequent weight gain are important events in women's history. Both pregnancy and postpartum are critical periods for the development of obesity. OBJECTIVES: To identify sociodemographic and reproductive risk factors associated with obesity in women in their fourth decade of life. METHODS: Cohort study conducted on women born from June 1978 to May 1979 in Ribeirão Preto, Brazil. Sociodemographic, clinical, and obstetric data were collected by interview and clinical evaluation. Univariable and multivariable binomial logistic regression models were constructed to identify the risk factors of obesity and the adjusted relative risk (RR) was calculated. RESULTS: The cohort included 916 women and 309 (33.7%) of them were obese. Obesity was associated with low educational level (RR 1.77, 95%CI 1.33-2.35) and teenage pregnancy (RR 1.46, 95%CI 1.10-1.93). There was no association of obesity with the other covariates studied. CONCLUSION: Obesity is associated with years of schooling and teenage pregnancy.

Cuidados reprodutivos para a pessoa transgênero ­ do planejamento gestacional ao puerpério: uma revisão narrativa / Reproductive care for transgender persons ­ from gestational planning to puerperium: a narrative review

Objetivo: Apesar de 0,69% da população brasileira em idade reprodutiva se identificar como transgênero, os cuidados relacionados ao ciclo gravídico-puerperal e ao planejamento gestacional ainda são desconhecidos pelos profissionais de saúde. Métodos: Esta revisão narrativa avaliou o planejamento gestacional e contracepção; a possibilidade do emprego de técnicas de reprodução assistida segundo as recomendações do Conselho Federal de Medicina no Brasil; e a gestação, pré-natal e puerpério na população transgênero. Resultados: Dos 664 artigos encontrados no PubMed e Embase, 29 foram considerados para a confecção desta revisão. O uso da testosterona por trans masculinos, apesar de promover amenorreia, não é considerado um método contraceptivo. Contraindicações aos métodos hormonais devem seguir as mesmas orientações propostas para as mulheres cisgênero. Cuidados pré-natais não diferem dos habituais, Pessoas transgênero podem desejar amamentar. Conclusão: O desconhecimento das melhores práticas voltadas para o acolhimento e seguimento das pessoas transgênero pode resultar em negligência aos cuidados essenciais durante esse período. O conhecimento e a validação dessas identidades e o preparo das equipes são essenciais para melhorar o acesso dessa população às redes de saúde.

Objective: Although 0.69% of the Brazilian population of reproductive age identify themselves as transgender, care related to the pregnancy-puerperal cycle and pregnancy planning is still unknown to health professionals. Methods: This narrative review assessed pregnancy planning and contraception; the possibility of using Assisted Reproduction Technologies according to the recommendations of the Federal Council of Medicine in Brazil; and pregnancy, prenatal, and puerperium in the transgender population. Results: Of the 664 articles found in PubMed and Embase, 29 were considered for the compilation of this review. The use of testosterone by transgender male, despite promoting amenorrhea, is not considered a contraceptive method. Contraindications to hormonal methods should follow the same guidelines for cisgender women. Prenatal care and delivery should not differ from the usual. Transgender might be able to breastfeed. Conclusion: The lack of knowledge for transgender follow-up may result in neglect of prenatal care. Knowledge and validation of these identities and staff training are essential to improve the access of this population to health networks.

Recommendations for standardization of bleeding data analyses in contraceptive studies.

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contraceptive is designed to result in a predictable or unpredictable bleeding pattern. Predictable pattern outcomes quantify days of scheduled, unscheduled and no bleeding, while unpredictable pattern outcomes assess frequency. Flow is quantified based on patient comparisons to their typical flow when not using contraception, with spotting representing no menstrual products use. Duration of a prolonged bleeding and/or spotting episode is more than 7 days. Studies should assess bleeding characteristics for a minimum of 12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables, and the full duration of use for long-acting contraceptives. Describing pattern, flow and duration as independent categories allows a fuller understanding of the bleeding outcomes and better future assessments of acceptability and continuation. Standardization of outcomes permits better comparison between studies and data synthesis; standardization will also improve the ability of clinicians and patients to understand differences between products.

[Factors associated with serious maternal morbidity in Ribeirão Preto, São Paulo State, Brazil: a cross-sectional cohort study]. / Fatores associados à morbidade materna grave em Ribeirão Preto, São Paulo, Brasil: estudo de corte transversal.

This study investigated the factors associated with serious maternal morbidity (SMM) in women seen at public maternity hospitals in Ribeirão Preto, São Paulo State, Brazil. This was a cross-section analytical quantitative study. Participation included 1,098 postpartum women who had given birth at one of the four maternity hospitals in the municipality. Data were collected from August 3, 2015, to February 2, 2016, using face-to-face interviews and data obtained from patient records and prenatal cards. The dependent variable for data analysis was the serious maternal morbidity, that is, when the woman was classified as maternal near miss or potentially life-threatening condition based on WHO eligibility criteria. The study calculated the maternal near miss ratio, odds ratio (OR), 95% confidence interval (95%CI), and multiple logistic regression. The maternal near miss ratio was 3.6 cases per 1,000 live births. Complications occurred mainly during pregnancy (53.8%), and hypertensive disorders were the most frequent (49.4%). Multiple regression analysis showed an association between serious maternal morbidity and high-risk pregnancy (OR = 4.5, 95%CI: 2.7-7.7) and induced labor (OR = 2.1, 95%CI: 1.2-3.9). The occurrence of serious maternal morbidity mainly during pregnancy, featuring hypertensive syndromes, points to the need for better screening and management of high blood pressure in the prenatal period. The association between serious maternal morbidity and high-risk pregnancy also calls attention to prenatal care, for the demand for greater care for women classified as having gestational risk. Quality of care is a key point for dealing with maternal morbidity and mortality in Brazil.

Este estudo investigou os fatores associados à morbidade materna grave entre mulheres atendidas em maternidades públicas do Município de Ribeirão Preto, São Paulo, Brasil. Trata-se de um estudo quantitativo, analítico, transversal. Participaram 1.098 puérperas com parto em uma das quatro maternidades públicas do município. A coleta de dados ocorreu entre 3 de agosto de 2015 e 2 de fevereiro de 2016, a partir de entrevistas face a face, obtenção de informações dos prontuários e dos cartões da gestante. Para a análise de dados, considerou-se como variável dependente a ocorrência de morbidade materna grave, ou seja, quando a mulher era classificada como near miss materno ou condição potencialmente ameaçadora à vida a partir dos critérios de elegibilidade da Organização Mundial de Saúde. Calculou-se a razão do near miss materno, odds ratio (OR), intervalo de 95% de confiança (IC95%) e regressão logística múltipla. A razão do near miss materno foi de 3,6 casos por mil nascidos vivos. As complicações ocorreram principalmente na gravidez (53,8%) e os distúrbios hipertensivos foram os mais frequentes (49,4%). A análise de regressão múltipla mostrou associação entre morbidade materna grave e gestação de risco (OR = 4,5; IC95%: 2,7-7,7) e com trabalho de parto induzido (OR = 2,1; IC95%: 1,2-3,9). A ocorrência de morbidade materna grave, principalmente na gestação, com destaque para as síndromes hipertensivas, aponta para a necessidade de melhor rastreamento e manejo da elevação dos níveis pressóricos no pré-natal. A associação entre morbidade materna grave e gestação de risco também remonta ao pré-natal, para a demanda de uma maior atenção às mulheres classificadas como risco gestacional. A qualidade da assistência é ponto chave para o enfretamento da morbimortalidade materna no país.

Este estudio investigó los factores asociados a la morbilidad materna grave entre mujeres atendidas en maternidades públicas del municipio de Ribeirão Preto, São Paulo, Brasil. Se trata de un estudio cuantitativo, analítico, transversal. Participaron 1.098 puérperas con parto en una de las cuatro maternidades públicas del municipio. La recogida de datos se produjo entre el 3 de agosto de 2015 al 2 de febrero de 2016, mediante entrevistas cara a cara, obtención de información de los historiales y cartillas de las gestantes. Para el análisis de datos, se consideró como variable dependiente la ocurrencia de morbilidad materna grave, o sea, cuando la mujer era clasificada como near miss materno o condición potencialmente amenazadora para la vida, a partir de los criterios de elegibilidad de la Organización Mundial de Salud. Se calculó la razón del near miss materno, odds ratio (OR), intervalo de 95% de confianza (IC95%) y regresión logística múltiple. La razón de near miss materno fue de 3,6 casos por 1.000 nacidos vivos. Las complicaciones se produjeron principalmente en el embarazo (53,8%) y las alteraciones hipertensivas fueron las más frecuentes (49,4%). El análisis de regresión múltiple mostró asociación entre morbilidad materna grave y gestación de riesgo (OR = 4,5; IC95%: 2,7-7,7) y con trabajo de parto inducido (OR = 2,1; IC95%: 1,2-3,9). La ocurrencia de morbilidad materna grave, principalmente en la gestación, resaltando los síndromes hipertensivos, apunta la necesidad de un mejor rastreo y gestión de la elevación de los niveles presión arterial en el período prenatal. La asociación entre morbilidad materna grave y gestación de riesgo también se remonta al período prenatal, con el fin de que se preste una mayor atención a las mujeres clasificadas como de riesgo gestacional. La calidad de la asistencia es un punto clave para combatir la morbimortalidad materna en el país.

Factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices.

OBJECTIVE: To identify clinical and demographic factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices (TCu380A IUD). METHODS: This is a secondary analysis of an implementation study. We followed participants who had a postplacental TCu380A IUD insertion, at two postpartum visits: 45-90 days (visit 1) and 6-9 months (visit 2). We used multiple log-binomial regression models to evaluate the demographic and clinical variables associated with missing strings and with IUD expulsion. RESULTS: We included 705 participants who had a postplacental IUD insertion. We observed missing strings in 275 (47.9%) participants at visit 1, and in 127 (34.2%) participants at visit 2. We identified 61 expulsions (8.9%) by visit 2. In the multiple regression models, only the delivery type was associated with missing strings and expulsion. Compared with vaginal delivery, cesarean delivery increased the risk of missing strings (adjusted relative risk [aRR] 6.21; 95% confidence interval [CI] 4.29-8.99) but reduced the risk of IUD expulsion (aRR 0.24; 95% CI 0.13-0.43). CONCLUSION: The delivery mode was the only factor associated with missing strings and expulsion after postplacental IUD insertion. Cesarean section was associated with an increased risk of missing strings but decreased risk of expulsion after postplacental TCu380A IUD insertion.

Fatores associados à morbidade materna grave em Ribeirão Preto, São Paulo, Brasil: estudo de corte transversal / Factors associated with serious maternal morbidity in Ribeirão Preto, São Paulo State, Brazil: a cross-sectional cohort study / Factores asociados a la morbilidad materna grave en Ribeirão Preto, São Paulo, Brasil: estudio de corte transversal

Este estudo investigou os fatores associados à morbidade materna grave entre mulheres atendidas em maternidades públicas do Município de Ribeirão Preto, São Paulo, Brasil. Trata-se de um estudo quantitativo, analítico, transversal. Participaram 1.098 puérperas com parto em uma das quatro maternidades públicas do município. A coleta de dados ocorreu entre 3 de agosto de 2015 e 2 de fevereiro de 2016, a partir de entrevistas face a face, obtenção de informações dos prontuários e dos cartões da gestante. Para a análise de dados, considerou-se como variável dependente a ocorrência de morbidade materna grave, ou seja, quando a mulher era classificada como near miss materno ou condição potencialmente ameaçadora à vida a partir dos critérios de elegibilidade da Organização Mundial de Saúde. Calculou-se a razão do near miss materno, odds ratio (OR), intervalo de 95% de confiança (IC95%) e regressão logística múltipla. A razão do near miss materno foi de 3,6 casos por mil nascidos vivos. As complicações ocorreram principalmente na gravidez (53,8%) e os distúrbios hipertensivos foram os mais frequentes (49,4%). A análise de regressão múltipla mostrou associação entre morbidade materna grave e gestação de risco (OR = 4,5; IC95%: 2,7-7,7) e com trabalho de parto induzido (OR = 2,1; IC95%: 1,2-3,9). A ocorrência de morbidade materna grave, principalmente na gestação, com destaque para as síndromes hipertensivas, aponta para a necessidade de melhor rastreamento e manejo da elevação dos níveis pressóricos no pré-natal. A associação entre morbidade materna grave e gestação de risco também remonta ao pré-natal, para a demanda de uma maior atenção às mulheres classificadas como risco gestacional. A qualidade da assistência é ponto chave para o enfretamento da morbimortalidade materna no país.

This study investigated the factors associated with serious maternal morbidity (SMM) in women seen at public maternity hospitals in Ribeirão Preto, São Paulo State, Brazil. This was a cross-section analytical quantitative study. Participation included 1,098 postpartum women who had given birth at one of the four maternity hospitals in the municipality. Data were collected from August 3, 2015, to February 2, 2016, using face-to-face interviews and data obtained from patient records and prenatal cards. The dependent variable for data analysis was the serious maternal morbidity, that is, when the woman was classified as maternal near miss or potentially life-threatening condition based on WHO eligibility criteria. The study calculated the maternal near miss ratio, odds ratio (OR), 95% confidence interval (95%CI), and multiple logistic regression. The maternal near miss ratio was 3.6 cases per 1,000 live births. Complications occurred mainly during pregnancy (53.8%), and hypertensive disorders were the most frequent (49.4%). Multiple regression analysis showed an association between serious maternal morbidity and high-risk pregnancy (OR = 4.5, 95%CI: 2.7-7.7) and induced labor (OR = 2.1, 95%CI: 1.2-3.9). The occurrence of serious maternal morbidity mainly during pregnancy, featuring hypertensive syndromes, points to the need for better screening and management of high blood pressure in the prenatal period. The association between serious maternal morbidity and high-risk pregnancy also calls attention to prenatal care, for the demand for greater care for women classified as having gestational risk. Quality of care is a key point for dealing with maternal morbidity and mortality in Brazil.

Este estudio investigó los factores asociados a la morbilidad materna grave entre mujeres atendidas en maternidades públicas del municipio de Ribeirão Preto, São Paulo, Brasil. Se trata de un estudio cuantitativo, analítico, transversal. Participaron 1.098 puérperas con parto en una de las cuatro maternidades públicas del municipio. La recogida de datos se produjo entre el 3 de agosto de 2015 al 2 de febrero de 2016, mediante entrevistas cara a cara, obtención de información de los historiales y cartillas de las gestantes. Para el análisis de datos, se consideró como variable dependiente la ocurrencia de morbilidad materna grave, o sea, cuando la mujer era clasificada como near miss materno o condición potencialmente amenazadora para la vida, a partir de los criterios de elegibilidad de la Organización Mundial de Salud. Se calculó la razón del near miss materno, odds ratio (OR), intervalo de 95% de confianza (IC95%) y regresión logística múltiple. La razón de near miss materno fue de 3,6 casos por 1.000 nacidos vivos. Las complicaciones se produjeron principalmente en el embarazo (53,8%) y las alteraciones hipertensivas fueron las más frecuentes (49,4%). El análisis de regresión múltiple mostró asociación entre morbilidad materna grave y gestación de riesgo (OR = 4,5; IC95%: 2,7-7,7) y con trabajo de parto inducido (OR = 2,1; IC95%: 1,2-3,9). La ocurrencia de morbilidad materna grave, principalmente en la gestación, resaltando los síndromes hipertensivos, apunta la necesidad de un mejor rastreo y gestión de la elevación de los niveles presión arterial en el período prenatal. La asociación entre morbilidad materna grave y gestación de riesgo también se remonta al período prenatal, con el fin de que se preste una mayor atención a las mujeres clasificadas como de riesgo gestacional. La calidad de la asistencia es un punto clave para combatir la morbimortalidad materna en el país.

Pharmacodynamics and pharmacokinetics of a copper intrauterine contraceptive system releasing ulipristal acetate: A randomized proof-of-concept study.

OBJECTIVES: To assess pharmacodynamic and pharmacokinetic outcomes of a novel copper (Cu) intrauterine system (IUS) releasing ulipristal acetate (UPA) in healthy women. STUDY DESIGN: In this single-blinded, randomized proof-of-concept study, ovulatory women received one of three Cu-IUSs releasing low-dose UPA (5, 20 or 40 µg/d) for 12 weeks. The study included a baseline cycle, three 4-week treatment-cycles and 2 recovery cycles. Primary outcomes included effects of the IUS on bleeding profile, ovarian function, and the occurrence of progesterone receptor modulator associated endometrial changes (PAEC). Pharmacokinetics and safety profile were secondary outcomes. We compared outcomes in treatment-cycle 3 with baseline, using generalized linear mixed models with orthogonal contrasts. RESULTS: We randomized 29 women (5 µg/d = 10, 20 µg/d = 10, 40 µg/d = 9). All had a successful IUS insertion; 27 completed the 12-week treatment period. Compared to baseline, the mean number of bleeding-only days at treatment-cycle 3 declined by 16.7% in the 5 µg/d group (3.6 vs 3.0, p = 0.66), 40.5% in the 20 µg/d group (4.2 vs 2.5, p = 0.14), and 77% in the 40 µg/d group (3.9 vs 0.9, p = 0.002). Most women reported reduction in the amount of bleeding: 4/8, 8/10, and 7/9 for the 5 µg/d, 20 µg/d, and 40 µg/d groups, respectively. During IUS use, ovulation occurred in most cycles [5 µg/d: 23/24 (96%), 20 µg/d: 26/30 (87%), 40 µg/d: 22/27 (81%)]. The frequency of PAEC at IUS removal was 1/10 (10%), 1/10 (10%) and 4/9 (44%) in the 5 µg/d, 20 µg/d, and 4 0 µg/d groups, respectively. No serious adverse events occurred. CONCLUSIONS: Reduction in bleeding, low incidence of PAEC, and no serious adverse events are reassuring findings of the novel Cu-UPA-IUS. The 20 µg/d seems the lowest dose promoting a favorable bleeding profile and limiting PAEC. IMPLICATIONS: The preliminary results of this short-term study of a novel copper intrauterine system (IUS) delivering ulipristal acetate showed reduction of bleeding, low incidence of progesterone receptor modulator associated endometrial changes, and absence of serious adverse events. By preventing copper-induced increase in bleeding, this IUS could provide a noncontraceptive benefit, especially for women with low hemoglobin.

Predictors of severe pain during insertion of the levonorgestrel 52 mg intrauterine system among nulligravid women.

OBJECTIVE: To identify sociodemographic and clinical variables associated with severe pain with levonorgestrel 52 mg intrauterine system (IUS) placement among nulligravid women. STUDY DESIGN: We performed a secondary analysis of a randomized trial that evaluated intracervical anesthesia before IUS insertion. We assessed factors associated with severe pain (visual analog scale pain score ≥7) immediately after insertion using bivariate and multiple regression analyses. RESULTS: Overall, 137/300 (45.7%) subjects reported severe pain. In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95% CI 1.08-1.72)] were associated with severe pain. CONCLUSIONS: Among nulligravid women, a history of dysmenorrhea increases, and intracervical block decreases severe pain during levonorgestrel IUS insertion. IMPLICATIONS: Dysmenorrhea increases the risk of severe pain at levonorgestrel intrauterine system insertion, while receiving an intracervical lidocaine block decreases this risk. This information can be useful for counseling women prior to device placement and for selecting candidates who may particularly benefit from interventions to reduce pain.

[Severe maternal morbidity in public hospitals in Ribeirão Preto, São Paulo State, Brazil]. / Morbidade materna grave em hospitais públicos de Ribeirão Preto, São Paulo, Brasil.

This study analyzed the occurrence of severe maternal morbidity, the most frequent diagnostic criteria, and the quality of obstetric care in public hospitals in Ribeirão Preto, São Paulo State, Brazil. A quantitative surveillance survey of severe maternal morbidity used World Health Organization (WHO) criteria for potentially life-threatening conditions and maternal near miss. Cases were identified from August 1, 2015, to February 2, 2016. The sample included 259 women with severe maternal morbidity (potentially life-threatening conditions/maternal near miss) during the gestational and postpartum cycle, hospitalized for childbirth in the four public institutions providing obstetric care in the city. The descriptive analysis was based on absolute and relative rates of diagnostic criteria for potentially life-threatening conditions and maternal near miss, besides description of the women in the sample (sociodemographic characteristics, obstetric history, and prenatal and childbirth care). Quality of care indicators set by the WHO based on morbimortality were also calculated. There were 3,497 deliveries, 3,502 live births in all the hospitals in the city, two maternal deaths, and 19 maternal near miss. Maternal near miss ratio was 5.4 cases per 1,000 live births, and the maternal mortality ratio was 57.1 deaths per 100,000 live birth. The mortality rate among cases with severe maternal outcome (maternal near miss plus maternal death) was 9.5%. The study revealed important potentially life-threatening conditions and maternal near miss rates. The occurrence of deaths from hemorrhagic causes highlights the need to improve the quality of obstetric care. The findings can potentially help improve local policy for obstetric care.

Sociodemographic factors and prenatal care behaviors associated with unplanned pregnancy in a Brazilian birth cohort study.

OBJECTIVE: To identify the sociodemographic factors and prenatal behavior characteristics associated with unplanned pregnancy. METHODS: A cross-sectional survey was conducted of mothers of newborns enrolled in a birth cohort in Ribeirão Preto, Brazil. Questionnaires were administered to postpartum women. Multiple logistic regression was used to identify sociodemographic predictors of unplanned pregnancy and to evaluate the association with adherence to prenatal care recommendations. RESULTS: The cohort included 7608 mothers: 7541 (99.1%) answered the interview and 4056 (53.8%) had an unplanned pregnancy. Adolescents were more likely to have an unplanned pregnancy (odds ratio [OR] 1.87; 95% confidence interval [CI] 1.50-2.34) as were women over 40 (OR 1.74; 95% CI 1.22-2.47). Pregnancy during adolescence (OR 1.27; 95% CI 1.09-1.48), being single (OR 7.56; 95% CI 5.98-9.56), having two or more previous births (OR 1.73; 95% CI 1.52-1.97), and being of a lower socioeconomic status were also predictors. Lack or late initiation of prenatal care, attendance at less than six prenatal visits, drinking alcohol, and smoking during pregnancy were associated with unplanned pregnancy. CONCLUSION: Unplanned pregnancies disproportionately affect women at extremes of age, single, and of low socioeconomic status. These women are less likely to adhere to prenatal care.

Best Practices for Counseling Adolescents about the Etonogestrel Implant.

Among young persons, ease of use, high efficacy, and high acceptability makes the etonogestrel contraceptive implant an important choice for this age group. Adolescent-friendly, patient-centered counseling considers the patient's cognitive development, the influence of friends and family, as well as their own preferences and values. Age-appropriate language, graphics, and models are useful to explain contraceptive options and relevant side effects. Effectiveness, reversibility, safety, noncontraceptive benefits, and side effects are important attributes and should be discussed when teens are choosing a contraceptive method. In this review we describe suggested best practices for counseling adolescents about the etonogestrel implant so they can make informed, prudent decisions about using this contraceptive method.

Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial.

BACKGROUND: Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion. OBJECTIVE: To evaluate whether a 3.6-mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas; and, in addition, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure. MATERIALS AND METHODS: In this randomized double-blind controlled trial, nulligravidas were block-randomized to 1 of 3 arms prior to 52-mg levonorgestrel-releasing intrauterine system insertion: 3.6-mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling), or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by healthcare providers), and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analogue scale and a 5-point Faces Pain Scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α = 0.05) to detect a 15% difference in pain score measured by visual analogue scale (mean [standard deviation] visual analogue scale score = 5.9 [2.0] cm) and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used a χ2 test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion. RESULTS: A total of 302 women were randomized (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention), and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P < .0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P < .0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups (intracervical block: 4.3 [3.8-4.9] vs sham: 6.6 [6.2-7.0], P < .0001; intracervical block: 4.3 [3.8-4.9] vs no intervention: 5.8 [5.3-6.4], P < .0001). Women from the intracervical block group reported less pain than expected (P < .0001), rated the insertion as less uncomfortable (P < .0001), and were more willing to undergo another device insertion in the future (P < .01) than women in the other groups. The ease of insertion were similar among groups. The number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively. CONCLUSION: A 3.6-mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.

Morbidade materna grave em hospitais públicos de Ribeirão Preto, São Paulo, Brasil / Severe maternal morbidity in public hospitals in Ribeirão Preto, São Paulo State, Brazil / Morbilidad materna grave en hospitales públicos de Ribeirão Preto, São Paulo, Brasil

Resumo: Este estudo objetivou investigar a ocorrência de morbidade materna grave, os critérios diagnósticos mais frequentes e a qualidade da assistência obstétrica nos hospitais públicos de Ribeirão Preto, São Paulo, Brasil. Trata-se de uma pesquisa quantitativa de vigilância das morbidades maternas graves, utilizando os critérios da Organização Mundial da Saúde (OMS) para condições potencialmente ameaçadoras à vida e near miss materno. Os casos foram identificados entre 1º de agosto de 2015 e 2 de fevereiro de 2016. Participaram 259 mulheres com morbidade materna grave (condições potencialmente ameaçadoras à vida/near miss materno) durante o ciclo gravídico-puerperal, internadas para o parto nas quatro instituições públicas com assistência obstétrica no município. Realizou-se análise descritiva a partir das frequências absolutas e relativas dos critérios diagnósticos para condições potencialmente ameaçadoras à vida e near miss materno, além da descrição das mulheres pesquisadas (caracterização sociodemográfica, antecedentes obstétricos, assistência pré-natal e ao parto). Indicadores de qualidade da assistência estabelecidos pela OMS a partir da morbimortalidade também foram calculados. Ocorreram 3.497 partos, 3.502 nascidos vivos em todos os hospitais do município, 2 mortes maternas e 19 near miss materno. A razão do near miss materno foi de 5,4 casos por 1.000 nascidos vivos, e a razão de mortalidade materna foi de 57,1 óbitos por 100 mil nascidos vivos. A taxa de mortalidade entre os casos com desfecho materno grave (somados os casos de near miss materno e morte materna) foi de 9,5%. Observou-se importante frequência de casos de condições potencialmente ameaçadoras à vida e near miss materno no presente estudo. A ocorrência de óbitos por causas hemorrágicas mostra a necessidade de melhoria da qualidade da assistência prestada. Os resultados poderão contribuir para o aprimoramento da política local de assistência obstétrica.

Abstract: This study analyzed the occurrence of severe maternal morbidity, the most frequent diagnostic criteria, and the quality of obstetric care in public hospitals in Ribeirão Preto, São Paulo State, Brazil. A quantitative surveillance survey of severe maternal morbidity used World Health Organization (WHO) criteria for potentially life-threatening conditions and maternal near miss. Cases were identified from August 1, 2015, to February 2, 2016. The sample included 259 women with severe maternal morbidity (potentially life-threatening conditions/maternal near miss) during the gestational and postpartum cycle, hospitalized for childbirth in the four public institutions providing obstetric care in the city. The descriptive analysis was based on absolute and relative rates of diagnostic criteria for potentially life-threatening conditions and maternal near miss, besides description of the women in the sample (sociodemographic characteristics, obstetric history, and prenatal and childbirth care). Quality of care indicators set by the WHO based on morbimortality were also calculated. There were 3,497 deliveries, 3,502 live births in all the hospitals in the city, two maternal deaths, and 19 maternal near miss. Maternal near miss ratio was 5.4 cases per 1,000 live births, and the maternal mortality ratio was 57.1 deaths per 100,000 live birth. The mortality rate among cases with severe maternal outcome (maternal near miss plus maternal death) was 9.5%. The study revealed important potentially life-threatening conditions and maternal near miss rates. The occurrence of deaths from hemorrhagic causes highlights the need to improve the quality of obstetric care. The findings can potentially help improve local policy for obstetric care.

Resumen: El objetivo de este estudio es investigar la ocurrencia de morbilidad materna grave, así como los criterios para los diagnósticos más frecuentes y la calidad de la asistencia obstétrica en hospitales públicos de Ribeirão Preto, Sao Paulo, Brasil. Se trata de una investigación cuantitativa de vigilancia de la morbilidad materna grave, utilizando criterios de la Organización Mundial de la Salud (OMS) sobre condiciones potencialmente amenazadoras para vida y near miss materno. Los casos se identificaron entre el 1 de agosto de 2015 y 2 de febrero de 2016. Participaron 259 mujeres con morbilidad materna grave (condiciones potencialmente amenazadoras para vida/near miss materno) durante el ciclo embarazo, parto y puerperio, internadas para el parto en cuatro instituciones públicas con asistencia obstétrica en el municipio. Se realizó un análisis descriptivo, a partir de frecuencias absolutas y relativas con criterios diagnósticos para condiciones potencialmente amenazadoras para vida y near miss materno, además de la descripción de las mujeres investigadas (caracterizaciones sociodemográficas, antecedentes obstétricos, asistencia prenatal y al parto). También se calcularon indicadores de calidad de asistencia establecidos por la OMS a partir de la morbimortalidad. Se produjeron 3.497 partos, 3.502 nacidos vivos en todos los hospitales del municipio, 2 muertes maternas y 19 near miss materno. La razón del near miss materno fue de 5,4 casos por 1.000 nacidos vivos y la razón de mortalidad materna fue 57,1 óbitos por 100.000 nacidos vivos. La tasa de mortalidad entre los casos con desenlace materno grave (sumados a los casos de near miss materno y muerte materna) fue de un 9,5%. Se observó una importante frecuencia de casos de condiciones potencialmente amenazadoras para vida y near miss materno en el presente estudio. La ocurrencia de óbitos por causas hemorrágicas expone la necesidad de una mejora de la calidad en la asistencia prestada. Los resultados podrán contribuir a la mejora de la política local de asistencia obstétrica.

Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials.

OBJECTIVES: To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S). STUDY DESIGN: We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18-40 years; BMI ≤29 kg/m2) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only. RESULTS: Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5-8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14-1.94]. Women with fewer years of schooling [

Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial.

OBJECTIVES: To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates. STUDY DESIGN: This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity). RESULTS: We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9). CONCLUSION: Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion. IMPLICATIONS: Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.

A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs.

OBJECTIVES: We explored levonorgestrel (LNG) concentrations, bleeding patterns and endometrial thickness in women with epilepsy (WWE) initiating an LNG-intrauterine device (IUD) co-administered with antiepileptic drugs (AEDs). STUDY DESIGN: This pilot study included 20 WWE ages 18 to 45 years with well-controlled seizures and stable AED regimens initiating a 52-mg LNG-IUD (20 mcg/d initial release). We collected blood and measured endometrial thickness before IUD placement and 21 days, 3 months and 6 months thereafter. Participants recorded bleeding/spotting daily. We measured total LNG (radioimmunoassay), serum hormone binding globulin (SHBG, immunoassay) and calculated the free LNG index. We compared total LNG, free LNG index, SHBG and endometrial thickness over time using a linear mixed-effects model. RESULTS: Total LNG, free LNG index and SBHG levels remained stable from day 21 throughout. Endometrial thickness decreased from a median of 5.9 mm [interquartile range (IQR) 4.6-7.5] at day 21 to 3.3mm (2.8-4.9) by month 6 (p=0.02). Bleeding and spotting days decreased from a median of 16 (IQR 13-23) in month 1 to 6.5 (IQR 4-8.5) in month 6 regardless of AED regimen. CONCLUSION: Like women without epilepsy, WWE initiating the LNG-IUD experience stable total LNG concentrations and decreasing endometrial thickness and bleeding over the first 6 months of use. IMPLICATIONS: Like women without epilepsy, WWE using antiepileptic drugs can expect a stable LNG concentration and decreasing bleeding during the first 6 months of LNG-IUD use. Our data can be useful for guidance of WWE considering use the LNG-IUD.

Factors associated with nonadherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring.

OBJECTIVES: We sought to identify factors associated with nonadherence to instructions for using a novel contraceptive providing 1 year of protection. STUDY DESIGN: Data from a multicountry Phase 3 trial of the Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR) were analyzed. Participants were instructed to use the CVR over 13 cycles and follow a 21/7 regimen. Their reports of CVR removals >2 h outside scheduled removal periods served as a proxy for nonadherence. We used multivariate logistic regression to determine factors associated with such use. RESULTS: Of 905 participants, 120 (13%) reported CVR removals >2 h. Removals for washing [odds ratio (OR) 3.96, 95% confidence interval (CI) 2.50-6.27] or sexual intercourse (OR 3.19, 95% CI 2.03-4.99), and finding CVR insertion difficult (OR 2.80, 95% CI 1.36-5.80) were factors associated with removals >2 h. Lower educational attainment also predicted ring removal >2 h (OR 3.23, 95% CI 1.55-6.75). Women residing in Europe or Australia were less likely to remove the ring for >2 h compared with women in the United States (OR 0.44, 95% CI 0.24-0.83 and OR 0.13, 95% CI 0.02-0.98, respectively). Participants who reported removals >2 h were more likely to discontinue CVR use (OR 1.93, 95% CI 1.24-2.95), report dissatisfaction (OR 2.20, 95% CI 1.32-3.69) and become pregnant during the study (OR 4.07, 95% CI 1.58-10.50). CONCLUSIONS: Removing the CVR for washing and removing it before intercourse are factors associated with nonadherence to ring use. These are important topics for counseling women who are considering or using vaginal rings, including the NES/EE CVR. IMPLICATIONS: Findings from this study may be useful in guiding counseling for current and prospective vaginal ring users. Anticipatory guidance should focus on how the ring feels in the vagina and during sex. Asking about ring removals may help identify women who are at increased risk for having an unplanned pregnancy.