The role of mifepristone on first trimester miscarriage treatment - A double-blind randomized controlled trial - MiFirsT.

OBJECTIVES: To evaluate the efficacy of combined mifepristone and misoprostol compared to misoprostol alone in outpatient medical treatment of first trimester miscarriage. Additionally, the study intends to compare the rate of complications, adverse effects, and treatment acceptability between groups. STUDY DESIGN: Single-center double-blind randomized placebo-controlled trial including women with diagnosis of missed first trimester miscarriage up to 9 weeks of gestation. RESULTS: Between April 2019 and November 2021, 216 women diagnosed with first trimester miscarriage up to 9 weeks of gestation were randomly assigned to mifepristone group or to misoprostol-alone group. Data from 105 women in mifepristone group and 103 women in misoprostol-alone group were analyzed, with no differences in baseline characteristics. The median time between medications (oral mifepristone/placebo and vaginal misoprostol) was nearly 43 h in both groups (p = 0.906). The median time to first follow-up was 2.6 weeks (IQR 1.0) in mifepristone group and 2.4 weeks (IQR 1.0) in misoprostol-alone group (p = 0.855). The overall success rate of medical treatment was significantly higher in the mifepristone-group comparing to misoprostol-alone group (94.3% vs. 82.5%, RR 1.14, 95% CI, 1.03-1.26; p = 0.008). Accordingly, the rate of surgical treatment was significantly lower in the mifepristone-group (5.7% vs.14.6%, RR 0.39, 95% CI, 0.16-0.97; p = 0.034). The composite complication rate was similar and lower than 4% in both groups. No case of complicated pelvic infection, hemodynamic instability or inpatient supportive treatment was reported. There were no significant differences in the rates of adverse events, median score for vaginal bleeding intensity or analgesics use. Despite the same median value, the score of abdominal pain intensity was significantly higher in the mifepristone-group (p = 0.011). In both groups, more than 65% of the women classified the treatment as "good" and 92% would recommend it to a friend on the same clinical situation. CONCLUSION: The mifepristone plus vaginal misoprostol combined treatment for medical resolution of first trimester miscarriage resulted in significant higher success rate and lower rate of surgical uterine evacuation comparing to misoprostol-alone treatment, with no relevant differences in adverse events or treatment acceptability.

[Demographic and Professional Characteristics of Specialists in Obstetrics and Gynecology Registered in Portugal: Needs, Resources and Challenges]. / Características Demográficas e Profissionais dos Especialistas em Ginecologia-Obstetrícia Registados em Portugal: Necessidades, Recursos e Desafios.

INTRODUCTION: The demographic and professional characteristics of specialists in Obstetrics and Gynecology registered in Portugal are presented and current and future needs assessed. MATERIAL AND METHODS: An analysis of the data from Instituto Nacional de Estatística, Ordem dos Médicos and a survey sent to the directors of the departments of Obstetrics and Gynecology of Portuguese hospitals was perfomed. In order to calculate the necessary number of specialists, established indicators of the activity of the specialty were used. RESULTS: In 2018, there were 1 437 441 consultations of Obstetrics and Gynecology, 89 110 major gynecologic surgeries and 85 604 deliveries. For that, 1065 Obstetrics and Gynecology physicians, working 40 hours per week, with no more than 40% aged 55 years of age and older or including 30 residents per year, are deemed necessary. According to the National Institute of Statistics, in the same year there were 1143 specialists in Portuguese hospitals, of which 234 worked in private hospitals. On the other hand, 1772 specialists were registered with the Ordem dos Médicos: 1163 (66%) were aged 55 years old or above and 84% of specialists under the age of 40 were females. In 2020, there were 864 specialists, 46% of which aged years of age and older working in 39 out of the 41 public or public-private departments that answered the survey. In 2035, an increase of 7% in the required number of specialists is expected. CONCLUSION: In Portugal, there is not lack of Obstetrics and Gynecology specialists in absolute numbers, but the large number of specialists aged 55 years of age and older, who are exempt from shifts in emergency department work, and the existence of regional asymmetries contribute to the perpetuation of some shortages of these healthcare professionals in several departments, namely in public hospitals.

Introdução: Apresentam-se as caraterísticas demográficas e profissionais dos especialistas de Ginecologia-Obstetrícia registados em Portugal e avaliam-se necessidades atuais e futuras.Material e Métodos: Analisaram-se dados do Instituto Nacional de Estatística, da Ordem dos Médicos e de resposta a questionário enviado a diretores de serviços hospitalares portugueses de Ginecologia-Obstetrícia. Calcularam-se as necessidades de especialistas com base em indicadores estabelecidos de atividade médica da especialidade.Resultados: Em 2018, registaram-se, em Portugal, 1 437 441 consultas da especialidade, 89 110 grandes cirurgias e 85 604 partos. Para essa atividade calcula-se serem necessários 1065 médicos da especialidade, em regime de 40 horas semanais, dos quais não mais do que 40% com idade igual ou superior a 55 anos; para manter este número são necessários 30 internos por ano. Segundo o Instituto Nacional de Estatística, nesse ano existiam 1143 especialistas nos hospitais portugueses, 234 dos quais em hospitais privados. Por outro lado, estavam inscritos 1772 especialistas na Ordem dos Médicos, dos quais 1163 (66%) apresentavam uma idade igual ou superior a 55 anos, sendo 84% dos especialistas com menos de 40 anos do sexo feminino. Em 2020, nos 39 dos 41 serviços públicos e público-privados que responderam ao questionário, existiam 864 especialistas, dos quais 395 (46%) com idade igual ou superior a 55 anos. Para 2035 prevê-se um aumento de 7% nas necessidades de especialistas desta área.Conclusão: Em Portugal não há falta de especialistas de Ginecologia-Obstetrícia em número absoluto, mas a existência de um elevado número de especialistas com idade igual ou superior a 55 anos, que tem direito a deixar de prestar atividade nos Serviços de Urgência, e de assimetrias regionais, contribuem para que continuem a existir algumas carências destes profissionais em vários serviços, nomeadamente em hospitais públicos.

The influence of preeclampsia, advanced maternal age and maternal obesity in neonatal outcomes among women with gestational diabetes / A influência da pré-eclâmpsia, idade materna avançada e obesidade materna em desfechos neonatais entre mulheres com diabetes gestacional

Abstract Objective The present study aims to analyze adverse fetal or neonatal outcomes in women with gestational diabetes, including fetal death, preterm deliveries, birthweight, neonatal morbidity and mortality, as well as the synergic effect of concomitant pregnancy risk factors and poor obstetric outcomes, as advanced maternal age, maternal obesity and pre-eclampsia in their worsening. Methods The present cohort retrospective study included all pregnant women with gestational diabetes, with surveillance and childbirth at the Hospital da Senhora da Oliveira during the years of 2017 and 2018. The data were collected from the medical electronic records registered in health informatic programs Sclinico and Obscare, and statistical simple and multivariate analysis was done using IBM SPSS Statistics. Results The study participants included 301 pregnant women that contributed to 7.36% of the total institution childbirths of the same years, in a total of 300 live births. It was analyzed the influence of pre-eclampsia coexistence in neonatal morbidity (p = 0.004), in the occurrence of newborns of low and very low birthweight (p < 0.01) and in preterm deliveries (p < 0.01). The influence of maternal obesity (p = 0.270; p = 0.992; p = 0.684) and of advanced maternal age in these 3 outcomes was also analyzed (p = 0,806; p = 0.879; p = 0.985).Using a multivariate analysis, the only models with statistic significance to predict the three neonatal outcomes included only pre-eclampsia (p = 0.04; p < 0.01; p < 0.01). Conclusion Only coexistence of pre-eclampsia showed an association with adverse neonatal outcomes (neonatal morbidity, newborns of low and very low birthweight and preterm deliveries) and can be used as a predictor of them in women with gestational diabetes.

Resumo Objetivo O presente estudo tem como objetivo analisar desfechos fetais ou neonatais adversos em mulheres com diabetes gestacional, incluindo morte fetal, partos prematuros, peso ao nascimento, morbilidade neonatal e mortalidade, bem como o efeito sinérgico de fatores de risco e maus desfechos concomitantes da gravidez, como idade materna avançada, obesidade materna e pré-eclâmpsia no seu agravamento. Métodos O presente estudo retrospetivo de coorte incluiu todas as gestantes com diabetes gestacional, com vigilância e parto no Hospital da Senhora da Oliveira durante 2017 e 2018. Os dados foram obtidos dos registos clínicos eletrônicos dos programas informáticos de saúde Sclinico e Obscare, e a análise estatística simples e multivariada foi feita utilizando o IBM SPSS Statistics. Resultados Os participantes do estudo incluíram 301 gestantes que contribuíram para 7,36% do total de partos da instituição, num total de 300 nados vivos. Foi analisada a influência da coexistência de pré-eclâmpsia na morbilidade neonatal (p = 0,004), na ocorrência de recém-nascidos de baixo e muito baixo peso ao nascimento (p < 0,01) e em partos prematuros (p < 0,01). Também foi analisada a influência da obesidade materna (p = 0,270; p = 0,992; p = 0,684) e da idade materna avançada nesses 3 desfechos (p = 0,806; p = 0,879; p = 0.985).Usando uma análise multivariada, os únicos modelos com significância estatística para predizer os três desfechos neonatais incluíram apenas a pré-eclâmpsia (p = 0,04; p < 0,01; p < 0,01). Conclusão Apenas a coexistência de pré-eclâmpsia mostrou associação com desfechos neonatais adversos (morbilidade neonatal, recém-nascidos de baixo e muito baixo peso e partos prematuros) e pode ser utilizada como preditor destes em mulheres com diabetes gestacional.

The Influence of Preeclampsia, Advanced Maternal Age and Maternal Obesity in Neonatal Outcomes Among Women with Gestational Diabetes.

OBJECTIVE: The present study aims to analyze adverse fetal or neonatal outcomes in women with gestational diabetes, including fetal death, preterm deliveries, birthweight, neonatal morbidity and mortality, as well as the synergic effect of concomitant pregnancy risk factors and poor obstetric outcomes, as advanced maternal age, maternal obesity and pre-eclampsia in their worsening. METHODS: The present cohort retrospective study included all pregnant women with gestational diabetes, with surveillance and childbirth at the Hospital da Senhora da Oliveira during the years of 2017 and 2018. The data were collected from the medical electronic records registered in health informatic programs Sclinico and Obscare, and statistical simple and multivariate analysis was done using IBM SPSS Statistics. RESULTS: The study participants included 301 pregnant women that contributed to 7.36% of the total institution childbirths of the same years, in a total of 300 live births. It was analyzed the influence of pre-eclampsia coexistence in neonatal morbidity (p = 0.004), in the occurrence of newborns of low and very low birthweight (p < 0.01) and in preterm deliveries (p < 0.01). The influence of maternal obesity (p = 0.270; p = 0.992; p = 0.684) and of advanced maternal age in these 3 outcomes was also analyzed (p = 0,806; p = 0.879; p = 0.985).Using a multivariate analysis, the only models with statistic significance to predict the three neonatal outcomes included only pre-eclampsia (p = 0.04; p < 0.01; p < 0.01). CONCLUSION: Only coexistence of pre-eclampsia showed an association with adverse neonatal outcomes (neonatal morbidity, newborns of low and very low birthweight and preterm deliveries) and can be used as a predictor of them in women with gestational diabetes.

OBJETIVO: O presente estudo tem como objetivo analisar desfechos fetais ou neonatais adversos em mulheres com diabetes gestacional, incluindo morte fetal, partos prematuros, peso ao nascimento, morbilidade neonatal e mortalidade, bem como o efeito sinérgico de fatores de risco e maus desfechos concomitantes da gravidez, como idade materna avançada, obesidade materna e pré-eclâmpsia no seu agravamento. MéTODOS: O presente estudo retrospetivo de coorte incluiu todas as gestantes com diabetes gestacional, com vigilância e parto no Hospital da Senhora da Oliveira durante 2017 e 2018. Os dados foram obtidos dos registos clínicos eletrónicos dos programas informáticos de saúde Sclinico e Obscare, e a análise estatística simples e multivariada foi feita utilizando o IBM SPSS Statistics. RESULTADOS: Os participantes do estudo incluíram 301 gestantes que contribuíram para 7,36% do total de partos da instituição, num total de 300 nados vivos. Foi analisada a influência da coexistência de pré-eclâmpsia na morbilidade neonatal (p = 0,004), na ocorrência de recém-nascidos de baixo e muito baixo peso ao nascimento (p < 0,01) e em partos prematuros (p < 0,01). Também foi analisada a influência da obesidade materna (p = 0,270; p = 0,992; p = 0,684) e da idade materna avançada nesses 3 desfechos (p = 0,806; p = 0,879; p = 0.985).Usando uma análise multivariada, os únicos modelos com significância estatística para predizer os três desfechos neonatais incluíram apenas a pré-eclâmpsia (p = 0,04; p < 0,01; p < 0,01). CONCLUSãO: Apenas a coexistência de pré-eclâmpsia mostrou associação com desfechos neonatais adversos (morbilidade neonatal, recém-nascidos de baixo e muito baixo peso e partos prematuros) e pode ser utilizada como preditor destes em mulheres com diabetes gestacional.