Active pelvic movements on a Swiss ball reduced labour duration, pain, fatigue and anxiety in parturient women: a randomised trial.

QUESTION: How much do active pelvic movements on a Swiss ball during labour affect maternal and neonatal outcomes? METHOD: A randomised trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Two-hundred parturient women. INTERVENTION: The experimental group performed pelvic anteversion and retroversion, lateral pelvic tilts and circular hip movements according to individual obstetric evaluation (foetal station and position, cervical dilatation and the presence of early pushing urge) on a Swiss ball. The control group received usual care. Both groups were permitted to walk and shower. OUTCOME MEASURES: The primary outcome was the duration of the first stage of labour. The secondary outcomes were the duration of the second stage of labour, pain intensity, delivery mode, medication use, local swelling, fatigue, anxiety, satisfaction and neonatal outcomes. RESULTS: The experimental intervention reduced the duration of labour by 179 minutes (95% CI 146 to 213) in stage one and 19 minutes (95% CI 13 to 25) in stage two. It decreased pain by approximately 2 points (95% CI 2 to 2) on a 0-to-10 scale at 30, 60 and 90 minutes. It reduced the risk of a caesarean section (ARR 0.14, 95% CI 0.03 to 0.25; NNT 7, 95% CI 4 to 32) and vulvar swelling (ARR 0.11, 95% CI 0.03 to 0.19; NNT 9, 95% CI 5 to 31). It reduced fatigue by 18 points (95% CI 16 to 21) on a 15-to-75-point scale and anxiety by 9 points (95% CI 8 to 11) on an 18-to-72-point scale. Other effects were negligible or unclear. CONCLUSION: Active pelvic movements on a Swiss ball during labour reduced the duration of labour, pain intensity, and maternal fatigue and anxiety; they also lowered the risk of caesarean section and vulvar swelling. Several effects exceeded the smallest worthwhile effect. REGISTRATION: NCT04124835.

Risk of adverse outcomes in offspring with RT-PCR confirmed prenatal Zika virus exposure: An individual participant data meta-analysis of 13 cohorts in the Zika Brazilian Cohorts Consortium.

Background: Knowledge regarding the risks associated with Zika virus (ZIKV) infections in pregnancy has relied on individual studies with relatively small sample sizes and variable risk estimates of adverse outcomes, or on surveillance or routinely collected data. Using data from the Zika Brazilian Cohorts Consortium, this study aims, to estimate the risk of adverse outcomes among offspring of women with RT-PCR-confirmed ZIKV infection during pregnancy and to explore heterogeneity between studies. Methods: We performed an individual participant data meta-analysis of the offspring of 1548 pregnant women from 13 studies, using one and two-stage meta-analyses to estimate the absolute risks. Findings: Of the 1548 ZIKV-exposed pregnancies, the risk of miscarriage was 0.9%, while the risk of stillbirth was 0.3%. Among the pregnancies with liveborn children, the risk of prematurity was 10,5%, the risk of low birth weight was 7.7, and the risk of small for gestational age (SGA) was 16.2%. For other abnormalities, the absolute risks were: 2.6% for microcephaly at birth or first evaluation, 4.0% for microcephaly at any time during follow-up, 7.9% for neuroimaging abnormalities, 18.7% for functional neurological abnormalities, 4.0% for ophthalmic abnormalities, 6.4% for auditory abnormalities, 0.6% for arthrogryposis, and 1.5% for dysphagia. This risk was similar in all sites studied and in different socioeconomic conditions, indicating that there are not likely to be other factors modifying this association. Interpretation: This study based on prospectively collected data generates the most robust evidence to date on the risks of congenital ZIKV infections over the early life course. Overall, approximately one-third of liveborn children with prenatal ZIKV exposure presented with at least one abnormality compatible with congenital infection, while the risk to present with at least two abnormalities in combination was less than 1.0%.

Effect of neurodevelopmental treatment in children with congenital Zika syndrome: A pilot study.

AIM: To evaluate the effects of neurodevelopmental treatment (NDT) in children with congenital Zika syndrome (CZS). METHODS: This prospective, interventional cohort study involved children with CZS undergoing follow-up at a specialist centre in northeastern Brazil. The duration of the proposed NDT protocol was 1 year, with 45-min sessions delivered one to five times weekly. Motor function, weight, height, head circumference and the incidence of comorbidities were evaluated in children before protocol initiation and then at 3, 6 and 12 months of treatment. RESULTS: Thirty children were evaluated (age mean 30.1 ± 3 months). Motor function improved from baseline to 6 months (P = 0.001). No difference in weight and head circumference z-score (P = 0.51 and P = 0.29, respectively), but an increase in height z-score (P < 0.001) was observed over the evaluation period. There was a reduction in the incidence of upper respiratory tract infections, pneumonia and urinary tract infections over the follow-up period. CONCLUSIONS: NDT proved to be a viable treatment approach that can improve motor function and reduce the incidence of comorbidities in children with CZS, while having no harmful effects on their growth.

Maternal mortality and COVID-19.

OBJECTIVE: The aim of this study was to collect and analyze data from different sources to have a general overview of COVID-19-related maternal deaths in Brazil, as well as to compare data with worldwide reports. STUDY DESIGN: We systematically searched data about COVID-19 maternal deaths from the Brazilian Ministry of Health surveillance system, State Departments of Health epidemiological reports, and media coverage. Data about timing of symptom onset and death (pregnancy or postpartum), gestational age, mode of birth, maternal age, comorbidities and/or risk factors, date of death, and place of death were retrieved when available. RESULTS: We identified 20 COVID-19-related maternal deaths, age range 20-43 years. Symptoms onset was reported as on pregnancy for 12 cases, postpartum for 3 cases, and during the cesarean section for 1 case (missing data for 4). In 16 cases, death occurred in the postpartum period. At least one comorbidity or risk factor was present in 11 cases (missing data for 4). Asthma was the most common risk factor (5/11). Ten cases occurred in the Northeast region, and nine cases occurred in the Southeast region (5 of them in São Paulo, the first epicenter of COVID-19 in the country). CONCLUSIONS: To the best of our knowledge, this is the largest available series of maternal deaths due to COVID-19. Barriers to access healthcare, differences in pandemic containment measures in the country and high prevalence of concomitant risk factors for COVID-19 severe disease may play a role in the observed disparity compared to worldwide reports on maternal outcomes.

COVID-19-related deaths among women of reproductive age in Brazil: The burden of postpartum.

OBJECTIVE: To compare risk of death due to COVID-19 among pregnant, postpartum, and non-pregnant women of reproductive age in Brazil, using the severe acute respiratory syndrome surveillance system (SARS-SS). METHODS: A secondary analysis was performed of the Brazilian official SARS-SS, with data retrieved up to August 17, 2020. Cases were stratified by pregnancy status, risk factors or co-morbidities, and outcome (death or recovery). Multiple logistic regression was employed to examine associations between independent variables and risk of death. RESULTS: A total of 24 805 cases were included, with 3129 deaths (12.6%), including 271 maternal deaths. Postpartum was associated with increased risk of death, admission to the intensive care unit (ICU), and mechanical ventilation. Co-morbidities with higher impact on case fatality rate among non-obstetric cases were cancer and neurological and kidney diseases. Among pregnant women, cancer, diabetes mellitus, obesity, and rheumatology diseases were associated with risk of death. In the postpartum subgroup, age over 35 years and diabetes mellitus were independently associated with higher chance of death. CONCLUSION: Postpartum was associated with worse outcomes among the obstetric population, despite lower risk of dying without accessing ICU care. Non-pregnant women with cancer, neurological diseases, and kidney diseases have a higher risk of death due to COVID-19.

Risk factors for adverse outcomes among pregnant and postpartum women with acute respiratory distress syndrome due to COVID-19 in Brazil.

OBJECTIVE: To evaluate whether clinical and social risk factors are associated with negative outcomes for COVID-19 disease among Brazilian pregnant and postpartum women. METHODS: A secondary analysis was conducted of the official Acute Respiratory Syndrome Surveillance System database. Pregnant and postpartum women diagnosed with COVID-19 ARDS until July 14, 2020, were included. Adverse outcomes were a composite endpoint of either death, admission to the intensive care unit (ICU), or mechanical ventilation. Risk factors were examined by multiple logistic regression. RESULTS: There were 2475 cases of COVID-19 ARDS. Among them, 23.8% of women had the composite endpoint and 8.2% died. Of those who died, 5.9% were not hospitalized, 39.7% were not admitted to the ICU, 42.6% did not receive mechanical ventilation, and 25.5% did not have access to respiratory support. Multivariate analysis showed that postpartum period, age over 35 years, obesity, diabetes, black ethnicity, living in a peri-urban area, no access to Family Health Strategy, or living more than 100 km from the notification hospital were associated with an increased risk of adverse outcomes. CONCLUSION: Clinical and social risk factors and barriers to access health care are associated with adverse outcomes among maternal cases of COVID-19 ARDS in Brazil.

Misoprostol administered sublingually at a dose of 12.5 µg versus vaginally at a dose of 25 µg for the induction of full-term labor: a randomized controlled trial.

BACKGROUND: Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25 µg. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous systematic review, the objective of this study was to compare the frequency of tachysystole as the main outcome measure when misoprostol is administered sublingually at the dose of 12.5 µg versus vaginally at a dose of 25 µg to induce labor in a full-term pregnancy with a live fetus. METHODS: A randomized, placebo-controlled, triple-blind clinical trial was conducted at two maternity hospitals in northeastern Brazil. Two hundred patients with a full-term pregnancy, a live fetus, Bishop score ≤ 6 and an indication for induction of labor were included. Following randomization, one group received 12.5 µg misoprostol sublingually and a vaginal placebo, while the other group received a sublingual placebo and 25 µg misoprostol vaginally. The primary outcome was the frequency of tachysystole. Student's t-test, the chi-square test of association and Fisher's exact test were used, as appropriate. Risk ratios and their 95% confidence intervals were calculated. RESULTS: The frequency of tachysystole was lower in the group using 12.5 µg misoprostol sublingually compared to the group using 25 µg misoprostol vaginally (RR = 0.15; 95%CI: 0.02-0.97; p = 0.002). Failure to achieve vaginal delivery within 12 and 24 h was similar in both groups. Sublingual administration was preferred to vaginal administration by women in both groups; however, the difference was not statistically significant. CONCLUSION: The effectiveness of labor induction with low-dose sublingual misoprostol was similar to that achieved with vaginal administration of the recommended dose; however, the rate of tachysystole was lower in the sublingual group, and this route of administration may prove a safe alternative. TRIAL REGISTRATION: Registration number: NCT01406392, ClinicalTrials.gov. Date of registration: August 1, 2011.

Effectiveness of an oral versus sublingual loading dose of nifedipine for tocolysis.

OBJECTIVE: To determine the effectiveness of an oral versus sublingual loading dose of nifedipine for tocolysis. METHODS: An open, randomized clinical trial conducted between March 1, 2013, and April 31, 2014. Participants were pregnant women with a diagnosis of premature labor, single live fetus, topical pregnancy, gestational age 24-36 weeks, normal fetal vitality, cervical dilatation less than or equal to 4 cm, cervical effacement less than or equal to 80%, and intact amniotic membranes. They were randomized into two groups, oral and sublingual nifedipine, 20 mg loading dose, repeated every 30 minutes (maximum dose of 60 mg). The primary endpoint was the time until tocolysis and the secondary endpoints were the effectiveness of tocolysis within 90 minutes, 12 hours, and 48 hours; premature delivery within 48 hours; and maternal hemodynamic parameters and side effects. RESULTS: There were 80 patients randomized to oral (n=40) and sublingual (n=40) nifedipine. The time required for tocolysis was significantly less with sublingual nifedipine (160 minutes vs 340 minutes; P=0.0003). Sublingual nifedipine was also more successful than oral nifedipine at inhibiting premature labor within 90 minutes (n=8 [20.0%] vs n=1 [2.5%], P=0.014). There was no statistically significant difference between the groups for the other secondary endpoints. CONCLUSION: Compared with oral administration, a sublingual loading dose of nifedipine resulted in faster tocolysis in patients with premature labor. Brazilian Clinical Trials Registry (ReBEC): U1111-11566186.

Motor function in children with congenital Zika syndrome.

AIM: To evaluate gross motor function and associated factors in children with congenital Zika syndrome (CZS). METHOD: Fifty-nine children (30 males, 29 females) with CZS at a mean (SD) age of 14.7 (3.9), months (range 5-29mo) were evaluated using the Gross Motor Function Measure (GMFM) and classified according to the Gross Motor Function Classification System (GMFCS). Neurological damage was evaluated by neuroimaging. The mothers' sociodemographic characteristics and general data on the children were obtained from interviews with the mothers and from the children's medical records. Correlational and multiple regression analyses were performed to identify factors associated with these children's motor function. RESULTS: In 81% of the children, motor function impairment was severe, classified as GMFCS level V. The overall GMFM score ranged from 5 to 210 (median 18; interquartile range 11), with only four children receiving scores in the D and E dimensions. The factors found to affect motor function were the presence of severe malformations of cortical development and small head circumference at birth. INTERPRETATION: Although motor impairment may be mild in some children, it is generally severe. Severe malformations of cortical development and small head circumference at birth were factors associated with poorer motor function, reflecting the greater severity of brain damage. WHAT THIS PAPER ADDS: Motor impairment is severe in most children with congenital Zika syndrome (CZS). Motor skills are adequate or close to adequate for age in 7% of children with CZS. Severe malformations of cortical development are associated with poor motor control. Small head circumference at birth is also associated with poor motor control.

FUNCIÓN MOTORA EN NIÑOS CON SÍNDROME DE ZIKA CONGÉNITO: OBJETIVO: Evaluar la función motora gruesa y los factores asociados en niños con síndrome de Zika congénito (CZS). MÉTODO: Cincuenta y nueve niños (30 varones, 29 mujeres) con CZS a una edad media (DE) de 14,7 (3,9), meses (rango 5-29 meses) se evaluaron utilizando la Medida de la función motora gruesa (GMFM) y se clasificaron de acuerdo con el Sistema de Clasificación de la Función Motora Gruesa (GMFCS). El impacto estructural neurológico se evaluó mediante neuroimagen. Las características sociodemográficas de las madres y los datos generales de los niños se obtuvieron en entrevistas con las madres y de los registros médicos de los niños. Se realizaron análisis de regresión correlacional y múltiple para identificar los factores asociados con la función motora de estos niños. RESULTADOS: En el 81% de los niños, el deterioro de la función motora fue grave, clasificado como nivel V de GMFCS. El puntaje general de GMFM varió de 5 a 210 (mediana 18; rango intercuartil 11), y solo cuatro niños recibieron puntajes en las dimensiones D y E. Los factores que afectaron la función motora fueron la presencia de malformaciones graves del desarrollo cortical y la circunferencia de la cabeza (microcefalia) al nacer. INTERPRETACIÓN: Aunque el deterioro motor puede ser leve en algunos niños, generalmente el impacto de CZS es grave. Las malformaciones graves del desarrollo cortical y la microcefalia al nacer fueron factores asociados con una función motora más limitada, lo que refleja la mayor gravedad del daño cerebral.

FUNÇÃO MOTORA EM CRIANÇAS COM SÍNDROME CONGÊNITA DE ZIKA: OBJETIVO: Avaliar a função motora grossa e fatores associados em crianças com síndrome congênita de Zika (SCZ). MÉTODO: Cinquenta e nove crianas (30 do sexo masculino, 29 do sexo feminino) com SCZ com uma média (DP) de idade de 14,7 (3,9) meses (variação 5-29m) foram avaliadas usando a Medida da Função Motora Grossa (GMFM) e classificadas de acordo com o Sistema de Classificação da Função Motora Grossa (GMFCS). O dano neurológico foi avaliado por neuroimagem. As características sócio-demográficas da mãe e dados gerais sobre as crianças foram obtidos em entrevistas com as mães e a partir dos prontuários medicos. Análises de correlação e de regressão múltipla foram realizadas para identificar fatores associados com a função motora destas crianças. RESULTADOS: Em 81% das crianças, o comprometimento da função motora era severo, classificao como nível GMFCS V. O escore geral da GMFM various de 5 a 210 (mediana 18; intervalo interquartil 11), com apenas quatro crianças recebendo pontuações nas dimensões D e E. Os fatores que afetaram a função motora grossa foram a presença de malformações severas no desenvolvimento cortical, e o pequeno perímetro cefálico ao nascimento. INTERPRETAÇÃO: Embora a deficiência motora possa ser leve em algumas crianças, em geral ela é severa. Malformações severas no desenvolvimento cortical e o pequeno perímetro cefálico foram fatores associados com pior função motora, refletindo a maior severidade do dano cerebral.

The tragedy of COVID-19 in Brazil: 124 maternal deaths and counting

Relatórios iniciais no início da pandemia de COVID-19 indicaram que a população obstétrica não parecia estar em maior risco de desenvolver sintomas graves de COVID-19 do que a população em geral. [1] No entanto, após publicações recentes que mostram que a gravidez e o período pós-parto podem realmente representar riscos adicionais para mulheres e bebês, essas observações preliminares requerem urgentemente revisão. [2] Explicações para risco aumentado podem incluir imunodeficiência relativa associada a adaptações fisiológicas maternas, bem como resposta orgânica a infecções por vírus.

Profile of women with anal neoplasia associated with cervical neoplasia receiving care at a tertiary healthcare facility in northeastern Brazil / Perfil de mulheres com neoplasia anal associada à neoplasia cervical atendidas em um serviço de saúde terciário do nordeste do Brasil

Abstract Objective: To describe the epidemiological, clinical and laboratory profiles of women with anal neoplasia associated with cervical neoplasia attending a tertiary healthcare facility in northeastern Brazil. Methods: This epidemiological, descriptive study was conducted using a database from a cross-sectional study carried out between December 2008 and January 2016. Women with a diagnosis of cervical neoplasia associated with anal neoplasia were included in the present study. Results: Of the women with cervical neoplasia, 14% were found to have an anal intraepithelial lesion or anal cancer. Median age was 33 years, 68% were non-white, and 70% were from urban regions, had little schooling and low income. Most reported having had anoreceptive (73%) and unprotected intercourse (84%). Regarding symptoms, 7% reported bleeding and 11% pruritus. Overall, 10% of the sample tested positive for the human immunodeficiency virus. Anal cytology was abnormal in 92%. High-resolution anoscopy was abnormal in all cases. Histopathology revealed three cases of invasive carcinoma and high-grade lesions in 32% of the cases. Conclusion: Women with a diagnosis of anal and cervical neoplasia are often young, non-white women, who initiated their sexual life at an early age, were exposed to unprotected anoreceptive intercourse, live in urban centers, have little schooling and a low-income level.

Resumo Objetivo: Descrever os perfis epidemiológico, clínico e laboratorial de mulheres com neoplasia anal associada à neoplasia cervical atendidas em uma unidade de saúde terciária no nordeste do Brasil. Métodos: Este estudo epidemiológico e descritivo usou um banco de dados de um estudo transversal realizado entre dezembro de 2008 e janeiro de 2016. Mulheres com diagnóstico de neoplasia cervical associada à neoplasia anal foram incluídas no presente estudo. Resultados: Das mulheres com neoplasia cervical, 14% apresentaram lesão intra-epitelial anal ou câncer anal. A mediana de idade foi de 33 anos; 68% das pacientes não eram brancas e 70% eram provenientes de regiões urbanas, com baixa escolaridade e baixa renda. A maioria relatou histórico de relações sexuais anoreceptivas (73%) e desprotegidas (84%). Quanto aos sintomas, 7% relataram sangramento e 11% prurido. No geral, 10% das pacientes apresentaram serologia positiva para o vírus da imunodeficiência humana. A citologia anal foi anormal em 92% da amostra. A anuscopia de alta resolução foi anormal em todos os casos. A histopatologia revelou três casos de carcinoma invasivo e lesões de alto grau em 32% dos casos. Conclusão: As mulheres com diagnóstico de neoplasia anal e cervical geralmente são jovens, não brancas, que iniciaram sua vida sexual em idade precoce, foram expostas a relações sexuais anoreceptivas desprotegidas, moram em centros urbanos e têm baixa escolaridade e baixo nível de renda.

Serum magnesium levels during magnesium sulfate infusion at 1 gram/hour versus 2 grams/hour as a maintenance dose to prevent eclampsia in women with severe preeclampsia: A randomized clinical trial.

BACKGROUND: Magnesium sulfate is the ideal drug for the prevention and treatment of eclampsia. Nevertheless, the best regimen for protection against eclampsia with minimal side effects remains to be established. This study aimed to compare serum magnesium levels during intravenous infusion of magnesium sulfate at 1 gram/hour versus 2 grams/hour as a maintenance dose to prevent eclampsia in pregnant and postpartum women with severe preeclampsia. METHODS: A randomized, triple-blind clinical trial was conducted, comparing serum magnesium levels during the intravenous infusion of magnesium sulfate at 1 gram/hour versus 2 grams/hour as a maintenance dose for the prevention of eclampsia in 62 pregnant and postpartum women with severe preeclampsia, 31 in each group. An intravenous loading dose of 6 grams of magnesium sulfate was administered over 30 minutes in both groups. The patients were then randomized to receive a maintenance dose of either 1 or 2 grams/hour for 24 hours. Primary outcomes consisted of serum magnesium levels at the following time points: baseline, 30 minutes, every 2 hours until the end of the first 6 hours, and every 6 hours thereafter until the termination of magnesium sulfate infusion. Side effects, maternal complications, and neonatal outcomes were the secondary outcomes. RESULTS: Serum magnesium levels were higher in the 2-gram/hour group, with a statistically significant difference from 2 hours after the beginning of the magnesium sulfate infusion (P <.05). Oliguria was the most common complication recorded in both groups, with no significant difference between the 2 regimens (RR 0.88; 95% CI: 0.49-1.56; P = .65). No cases of eclampsia occurred. Side effects were more common in the 2-gram/hour group (RR 1.89; 95% CI: 1.04-3.41; P = .02); however, all were mild. There were no differences between the 2 groups regarding neonatal outcomes, except for admission to neonatal intensive care, which was more frequent in the 1-gram/hour group (25% vs 6.3%; P = .04). CONCLUSION: Magnesium sulfate therapy at the maintenance dose of 1 gram/hour was just as effective as the 2-gram maintenance dose, with fewer side effects.

Anal prevalence of HPV in women with pre-malignant lesion or cancer in the cervix and anal canal simultaneously: cross-sectional study.

OBJECTIVE: To determine the prevalence of anal HPV genotypes and associated factors in women with pre-malignant lesion or cancer in the cervix and anal canal. METHODS: A prospective, cross-sectional study analyzed DNA samples taken from women with cervical pre-malignant lesions or cancer to identify anal HPV by polymerase chain reaction (PCR). The prevalence of high-risk HPV (HR-HPV) in women with intraepithelial neoplasia and anal cancer was calculated; sociodemographic and clinical risk factors were identified using multivariate analysis. RESULTS: A total of 152 patients were included (mean age 37.8 ± 10.01 years), of whom 101 (66.4%) had anal HR-HPV. Fourteen different anal HPV types were identified. HPV 16 and 18 were found in 30 (52.6%) anal high-grade squamous intraepithelial lesions (HSIL), and HPV 31 and 33 in 21 (36.8%) lesions. In the logistic regression analysis, the factors that remained associated with HR-HPV types were: an anal histopathology report of HSIL or invasive carcinoma (odds ratio [OR] 8.96, 95% confidence interval [CI] 3.40-23.57; P<0.0001) and alcohol consumption (OR 2.20, 95% CI 1.01-4.80; P=0.04). CONCLUSION: Prevalence of HR-HPV is high in the anal canal of women with cervical and anal pre-malignant lesions simultaneously or cancer of the cervix and/or anal canal. HPV 16, 31, 33, and 18 were the four major genotypes identified.

Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

BACKGROUND: In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial. METHODS: The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made. RESULTS: Overall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system. CONCLUSIONS: The decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.

Acute pulmonary edema in an obstetric intensive care unit: A case series study.

Acute pulmonary edema (PE) affects 0.08% to 1.5% of women during pregnancy and in the postpartum. At the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), acute PE accounts for 1.5% of admissions to the obstetric intensive care unit (ICU) and occurs in 9.3% of the patients admitted with near miss criteria. This study was conducted to describe the clinical/epidemiological profile of patients with acute PE in IMIP's obstetric ICU.A case series of 50 patients with acute PE in an obstetric ICU in northeastern Brazil between August 2012 and March 2015. Frequency distribution and measures of central tendency/dispersion were calculated using Epi Info, version 7.1.5.The mean age of the women was 27.2 years; 60% were from Recife; 50% had 8 to 11 years of schooling; 54.0% were primigravidas. Acute PE occurred antepartum (58%), postpartum (38%), or intrapartum (4.0%). Overall, 8% had had previous episodes; 6% relapsed during hospitalization; 4% died. Caesarean sections were common (78.0%), with 73.3% delivering at <37 weeks and 39.0% at <34 weeks. Etiologies were hypertensive (62%), cardiogenic (16.0%), both hypertensive and cardiogenic (20.0%) or due to fluid overload (2.0%). Irrespective of etiology, in the 24 hours preceding acute PE, fluid overload was present in 34.0%. Median time from diagnosis until resuscitation maneuvers was 5 minutes (within 30 minutes of diagnosis in 75.0% of patients). Mean ICU time was 5 days and mean hospitalization time 11 days.Acute PE is a severe disease resulting in high maternal/perinatal morbidity/mortality rates. Most commonly, it occurred antepartum and associated with hypertension. Fluid overload appears to constitute an important trigger.

Correlation between electromyography and perineometry in evaluating pelvic floor muscle function in nulligravidas: A cross-sectional study.

OBJECTIVE: To correlate the results of electromyography and perineometry in the assessment of PFM function in nulligravidas. METHODS: The cross-sectional observational study was approved by the internal review board of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) and was conducted in the Instituto Paraibano de Pesquisa Professor Joaquim Amorim Neto (IPESQ). Thirty-eight nulligravidas aged 18-39 years of age, who had already initiated their sexual life, participated in the study. Exclusion criteria consisted of the presence of genital prolapse, a history of pelvic or urogenital surgery and the presence of neurological disease producing muscle disorders. For the evaluation procedure, the women were submitted to a clinical evaluation of the pelvic floor muscles followed by electromyography. Perineometry was performed 72 h later. Prior to electromyography and perineometry, the women were given standardized training with electromyographic biofeedback to teach them to contract only their pelvic floor muscles. RESULTS: A highly positive, statistically significant correlation (r = 0.968; P < 0.001) was found between the electromyographic and perineometric findings. CONCLUSIONS: A strong correlation was found between perineometric and electromyographic findings of pelvic floor muscle function.