RESUMO
BACKGROUND: Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. METHODS: This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. DISCUSSION: The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03073317.
Assuntos
Pré-Eclâmpsia/terapia , Nascimento Prematuro/prevenção & controle , Corticosteroides/uso terapêutico , Anticonvulsivantes/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Brasil , Atenção à Saúde/métodos , Gerenciamento Clínico , Feminino , Pessoal de Saúde/educação , Humanos , Sulfato de Magnésio/uso terapêutico , Fator de Crescimento Placentário/sangue , Pré-Eclâmpsia/sangue , Gravidez , Cuidado Pré-Natal , Medição de Risco , Convulsões/prevenção & controle , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangueRESUMO
BACKGROUND: The prevalence of hypertensive disorders during pregnancy is high in developing countries such as Haiti, however little is known about postpartum hypertension (PPHTN). METHODS: This is a prospective study done at Hospital Albert Schweitzer in rural Haiti among pregnant women age 18 or older who were admitted for labor. Blood pressures were collected before and after delivery and medical charts were reviewed to gather delivery characteristics and fetal/neonatal outcomes. Differences between groups are presented based on postpartum blood pressures (BP) as mild PPHTN (systolic BP≥140 or diastolic BP≥90) and severe PPHTN (systolic BP≥160 or diastolic BP≥110). RESULTS: Of 175 women, the prevalence of PPHTN during the two-month study period was 57.1% (97/172) and included 56 parturients with mild and 41 with severe PPHTN. Severe PPHTN was associated with a higher proportion of complications including abruption (14.6%), fetal (14.6%) and neonatal death (7.3%). Thirty-nine (69.6%) patients with mild PPHTN and 9 (21.9%) patients with severe PPHTN did not receive any antihypertensive medications postpartum. Patients with severe PPHTN had prolonged hospitalization compared to the normal group (3.5 vs. 2.0days, p=0.0003). There was a strong correlation between antepartum and postpartum systolic and diastolic BP's (r=0.62 and 0.54, p<0.0001, respectively). CONCLUSION: In this study, we identified a high prevalence of PPHTN in rural Haiti. Severe PPHTN was associated with adverse outcomes and treatment is not universal. This data is a starting point to develop region-specific protocols to treat and control PPHTN.
Assuntos
Hipertensão/epidemiologia , Transtornos Puerperais/epidemiologia , Adulto , Feminino , Haiti/epidemiologia , Humanos , Hipertensão/etiologia , Serviços de Saúde Materna , Cuidado Pós-Natal , Gravidez , Prevalência , Estudos Prospectivos , Transtornos Puerperais/etiologia , Fatores de Risco , População Rural , Adulto JovemRESUMO
OBJECTIVES: To compare the Multistix 10SG/visual-read with two automated methods (Multistix 10SG/Clinitek 50 and Chemstrip 10A/Urisys 1100) to detect significant proteinuria among high-risk pregnant women. STUDY DESIGN: Prospective cohort study at British Columbia Women's Hospital & Health Centre, Vancouver, Canada. MAIN OUTCOME MEASURES: Diagnostic accuracy determined by sensitivity, specificity, positive and negative likelihood ratios (LR+ and LR-). RESULTS: 303 (89.6%) of 338 women had a urine sample tested by all three dipstick methods. 196 samples (64.7%) were collected in the morning (subsequent to their first void) and from outpatients. 107 samples (35.3%) were from inpatients at various times throughout the day. A PrCr ⩾30mg/mmol was present in 46 (15.2%) samples. The sensitivity for proteinuria was higher with Multistix 10SG/Clinitek 50 (65.2%) than with Multistix 10SG/visual-read (41.3%, p<0.001) or Chemstrip 10A/Urisys 1100 (54.3%, p=0.06). Specificity was >90% for all methods studied, although it was highest for Multistix 10SG/visual-read (98.4%) compared with either Multistix 10SG/Clinitek 50 (92.6%, p<0.001) or Chemstrip 10A/Urisys 1100 (95.7%, p=0.04). For all methods, LR+ was good-excellent (>5), but LR- poor-fair (>0.20). 29 samples were discordant for proteinuria between methods. 28/29 women had negative proteinuria by Multistix 10SG/visual-read, but at least 1+ proteinuria by an automated method; 17/28 were false positives and 11/28 true positives. CONCLUSIONS: Automated dipstick methods are more sensitive than visual urinalysis for proteinuria, but test performance is still only poor-fair as a 'rule-out' test for proteinuria. Whether the enhanced sensitivity would be worth the false positives, cost, and personnel training remains to be determined for detection of low-level proteinuria in pregnancy.
Assuntos
Proteinúria/urina , Fitas Reagentes , Autoanálise , Estudos de Coortes , Reações Falso-Positivas , Feminino , Humanos , Pré-Eclâmpsia/urina , Gravidez , Estudos Prospectivos , Proteinúria/diagnóstico , Sensibilidade e EspecificidadeRESUMO
The hypertensive disorders of pregnancy are leading causes of maternal mortality and morbidity, especially in low- and middle-income countries. Early identification of women with preeclampsia and other hypertensive disorders of pregnancy at high risk of complications will aid in reducing this health burden. The fullPIERS model (Preeclampsia Integrated Estimate of Risk) was developed for predicting adverse maternal outcomes from preeclampsia using data from tertiary centers in high-income countries and uses maternal demographics, signs, symptoms, and laboratory tests as predictors. We aimed to assess the validity of the fullPIERS model in women with the hypertensive disorders of pregnancy in low-resourced hospital settings. Using miniPIERS data collected on women admitted with hypertensive disorders of pregnancy between July 2008 and March 2012 in 7 hospitals in 5 low- and middle-income countries, the predicted probability of developing an adverse maternal outcome was calculated for each woman using the fullPIERS equation. Missing predictor values were imputed using multivariate imputation by chained equations. The performance of the model was evaluated for discrimination, calibration, and stratification capacity.Among 757 women with complete predictor data (complete-case analyses), the fullPIERS model had a good area under the receiver-operating characteristic curve of 0.77 (95% confidence interval, 0.72-0.82) with poor calibration (P<0·001 for the Hosmer-Lemeshow goodness-of-fit test). Performance as a rule-in tool was moderate (likelihood ratio: 5.9; 95% confidence interval, 4.23-8.35) for women with ≥30% predicted probability of an adverse outcome. The fullPIERS model may be used in low-resourced setting hospitals to identify women with hypertensive disorders of pregnancy at high risk of adverse maternal outcomes in need of immediate interventions.
Assuntos
Hipertensão Induzida pela Gravidez/epidemiologia , Renda , Medição de Risco/métodos , Adulto , Brasil/epidemiologia , Feminino , Fiji/epidemiologia , Seguimentos , Humanos , Morbidade/tendências , Paquistão/epidemiologia , Gravidez , Resultado da Gravidez , Prognóstico , Curva ROC , Estudos Retrospectivos , Fatores de Risco , África do Sul/epidemiologia , Taxa de Sobrevida/tendências , Uganda/epidemiologia , Adulto JovemRESUMO
Nausea and vomiting are very common during pregnancy, mainly throughout the first trimester. Metoclopramide is a dopamine receptor blocking drug that is commonly used to treat nausea and vomiting. The aim of this prospective study was to investigate the effect on the fetus of intrauterine exposure to metoclopramide. One hundred and seventy-five women who received metoclopramide and consulted 6 teratogen information centers in Israel, Italy, Brazil, and Canada were studied. Women exposed to metoclopramide were paired for age, smoking and alcohol consumption habits with women exposed to nonteratogens. Women in the metoclopramide group had a significantly higher rate of premature births (8.1%) as compared with the control group (2.4%) ( p = 0.02, relative risk = 3.37, 95% confidence interval 1.12-10.12). Rates of major malformations in the metoclopramide group (4.4%) did not differ from controls (4.8%) ( p = 0.84, relative risk = 0.91, 95% confidence interval 0.34-2.45). According to our findings, metoclopramide use during the first trimester of pregnancy does not appear to be associated with an increased risk of malformations, spontaneous abortions, or decreased birth weight, however, larger studies are needed to confirm these observations.