RESUMEN
OBJECTIVE: To externally validate the CIPHER (Collaborative Integrated Pregnancy High-Dependency Estimate of Risk) prognostic model for pregnant and postpartum women admitted to the intensive care unit. METHODS: A retrospective and a prospective validation study were conducted at two reference centers in Brazil. A composite outcome was defined as maternal death or need for prolonged organ support (more than 7 days) or acute lifesaving intervention. To evaluate the performance of the CIPHER model, a receiver operating characteristic curve was used and score calibration was assessed by the Hosmer-Lemeshow test. We conducted a descriptive analysis comparing the results of the current study with the results of the model development study. RESULTS: A total of 590 women were included. The composite outcome was observed in 90 (15.2%) women. Of these, 13 (2.2%) were maternal deaths and 77 (13%) required one or more component of organ support or lifesaving intervention. The CIPHER model's area under the curve (AOC) did not show significant predictive ability (AOC 0.53, 95% CI 0.46-0.60), and consequently its calibration was poor (Hosmer-Lemeshow test P<.05). CONCLUSION: The CIPHER model for prediction of mortality and need for interventions in critically ill obstetric patients did not perform well in our Brazilian population. Different predictors of morbidity and mortality may need to be used for patients receiving care in public hospitals in low- and middle-income countries.
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Enfermedad Crítica , Complicaciones del Embarazo/terapia , Atención Prenatal , Riesgo , Índice de Severidad de la Enfermedad , Adulto , Brasil , Femenino , Humanos , Muerte Materna , Embarazo , Complicaciones del Embarazo/mortalidad , Pronóstico , Estudios Prospectivos , Derivación y Consulta , Reproducibilidad de los Resultados , Estudios Retrospectivos , Adulto JovenRESUMEN
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.
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Preeclampsia/terapia , Nacimiento Prematuro/prevención & control , Corticoesteroides/uso terapéutico , Anticonvulsivantes/uso terapéutico , Antihipertensivos/uso terapéutico , Brasil , Atención a la Salud/métodos , Manejo de la Enfermedad , Femenino , Personal de Salud/educación , Humanos , Sulfato de Magnesio/uso terapéutico , Factor de Crecimiento Placentario/sangre , Preeclampsia/sangre , Embarazo , Atención Prenatal , Medición de Riesgo , Convulsiones/prevención & control , Receptor 1 de Factores de Crecimiento Endotelial Vascular/sangreRESUMEN
BACKGROUND: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks' gestation) prevents the development of pre-eclampsia METHODS: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks' gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks' gestation. The allocation sequence (1:1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017. FINDINGS: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks' gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks' gestation (risk ratio [RR] 0·80, 95% CI 0·61-1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks' gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44-0·98; p=0·037). There were no serious adverse effects of calcium reported. INTERPRETATION: Calcium supplementation that commenced before pregnancy until 20 weeks' gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention. FUNDING: The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO; the Argentina Fund for Horizontal Cooperation of the Argentinean Ministry of Foreign Affairs; and the Centre for Intervention Science in Maternal and Child Health.
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Calcio/administración & dosificación , Suplementos Dietéticos , Preeclampsia/prevención & control , Atención Prenatal/métodos , Adulto , Argentina , Países en Desarrollo , Método Doble Ciego , Femenino , Edad Gestacional , Salud Global , Humanos , Embarazo , Factores de Riesgo , Sudáfrica , Adulto Joven , ZimbabweRESUMEN
OBJECTIVES: To compare scores on the 36-item WHO Disability Assessment Schedule 2.0 tool (WHODAS-36) for postpartum women across a continuum of morbidity and to validate the 12-item version (WHODAS-12). METHODS: This is a secondary analysis of the Brazilian retrospective cohort study on long-term repercussions of severe maternal morbidity. We determined mean, median, and percentile values for WHODAS-36 total score and for each domain, and percentile values for WHODAS-12 total score in postpartum women divided into three groups: "no," "nonsevere," and "severe" morbidities. RESULTS: The WHODAS-36 mean total scores were 11.58, 18.31, and 19.19, respectively for no, nonsevere, and severe morbidity. There was a dose-dependent effect on scores for each domain of WHODAS-36 according to the presence and severity of morbidity. The diagnostic validity of WHODAS-12 was determined by comparing it with WHODAS-36 as a "gold standard." The best cut-off point for diagnosing dysfunctionality was the 95th percentile. CONCLUSION: The upward trend of WHODAS-36 total mean value scores of women with no morbidity compared with those with morbidity along a severity continuum may reflect the impact of morbidity on postpartum functioning.
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Evaluación de la Discapacidad , Periodo Posparto , Adulto , Brasil , Femenino , Humanos , Masculino , Morbilidad , Valores de Referencia , Reproducibilidad de los Resultados , Estudios Retrospectivos , Organización Mundial de la Salud , Adulto JovenRESUMEN
OBJECTIVE: To validate the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item tool against the 36-item version for measuring functioning and disability associated with pregnancy and the occurrence of maternal morbidity. METHODS: This is a secondary analysis of the Brazilian retrospective cohort study on long-term repercussions of severe maternal morbidity (SMM) among women who delivered at a tertiary facility (COMMAG study). We compared WHODAS-12 and WHODAS-36 scores of women with and without SMM using measures of central tendency and variability, tests for instruments' agreement (Bland-Altman plot), confirmatory factor analysis (CFA), and Cronbach alpha coefficient for internal consistency. RESULTS: The COMMAG study enrolled 638 women up to 5 years postpartum. Although the median WHODAS-36 and -12 scores for all women were statistically different (13.04 and 11.76, respectively; P<0.001), there was a strong linear correlation between them. Furthermore, the mean difference and the differences in variance analyses demonstrated agreement of total scores between the two versions. CFA demonstrated how the WHODAS-12 questions are divided into six previously defined factors and Cronbach alpha showed good internal consistency. CONCLUSION: WHODAS-12 demonstrated agreement with WHODAS-36 for total score and was a good instrument for screening functioning and disability among postpartum women, with and without SMM.
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Evaluación de la Discapacidad , Periodo Posparto , Complicaciones del Embarazo/epidemiología , Brasil , Femenino , Humanos , Embarazo , Reproducibilidad de los Resultados , Estudios Retrospectivos , Organización Mundial de la SaludRESUMEN
OBJECTIVE: To assess the scores of postpartum women using the WHO Disability Assessment Schedule 2.0 36-item tool (WHODAS-36), considering different morbidities. METHODS: Secondary analysis of a retrospective cohort of women who delivered at a referral maternity in Brazil and were classified with and without severe maternal morbidity (SMM). WHODAS-36 was used to assess functioning in postpartum women. Percentile distribution of total WHODAS score was compared across three groups: Percentile (P)<10, 10
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Hipertensión/epidemiología , Hemorragia Posparto/epidemiología , Periodo Posparto , Complicaciones del Embarazo/epidemiología , Brasil , Parto Obstétrico , Femenino , Humanos , Morbilidad , Parto , Embarazo , Estudios RetrospectivosRESUMEN
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.
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Proteinuria/orina , Tiras Reactivas , Autoanálisis , Estudios de Cohortes , Reacciones Falso Positivas , Femenino , Humanos , Preeclampsia/orina , Embarazo , Estudios Prospectivos , Proteinuria/diagnóstico , Sensibilidad y EspecificidadRESUMEN
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.