RESUMEN
OBJECTIVE: Daily aspirin, started in the first trimester of pregnancy, is commonly used for the prevention of preeclampsia and fetal growth restriction in multiple gestation. However, the optimal dose remains controversial and the evidence for the use of aspirin in multiple pregnancies is scarce. We aimed to estimate the impact of 80 mg of aspirin in twin pregnancies. STUDY DESIGN: We performed a pilot double-blind randomized trial of women with twin pregnancies recruited between 8 and 14 weeks of gestation. Fifty participants (25 in each group) were randomized to 80 mg of aspirin daily at bedtime or a placebo from randomization until 36 weeks of gestation. Primary and secondary outcomes included the birth weight of live infants, preeclampsia, and aspirin responsiveness evaluated by a platelet aggregation test (platelet function assay [PFA]-100). RESULTS: All participants were followed until birth, including 48 and 47 live newborns in the aspirin and the placebo groups, respectively. The mean birth weight difference between the aspirin (2,385 ± 529 g) and placebo (2,224 ± 706 g) groups was of 179 g (95% confidence interval [CI]: -172-531 g, p = 0.32). We observed two (8%) cases of preeclampsia in the aspirin group and no case with placebo (p = 0.49). Most importantly,16 of 24 participants who received aspirin (67%; 95% CI: 45-84%) had a normal PFA-100 test at 22 to 23 weeks, including the two cases of preeclampsia, suggesting that the majority of the participants were nonresponsive to 80 mg of aspirin. CONCLUSION: Our results suggest that the majority of women with twin pregnancies showed a lack of response to a daily dose of 80 mg of aspirin according to the PFA-100 test, compared with the expected 29% of nonresponsiveness in singleton pregnancies. A daily dose of 80 mg of aspirin is likely to be insufficient for the prevention of preeclampsia and other placenta-mediated complications in twin pregnancies. KEY POINTS: · Most women with twin pregnancies are nonresponsive to a daily dose of 80-mg aspirin.. · An 80 mg aspirin dose is insufficient to prevent placenta-mediated complications in twin pregnancies.. · Randomized trials using 100 to 160 mg of aspirin in twin pregnancies are needed..
Asunto(s)
Aspirina , Preeclampsia , Peso al Nacer , Femenino , Humanos , Recién Nacido , Proyectos Piloto , Inhibidores de Agregación Plaquetaria , Preeclampsia/prevención & control , Embarazo , Embarazo GemelarRESUMEN
BACKGROUND: The Fetal Medicine Foundation proposed a competing risks model for early identification of women at a high risk of preterm preeclampsia, typically associated with deep placentation disorders. The Great Obstetrical Syndromes include a spectrum of pregnancy complications (preeclampsia, intrauterine growth restriction, preterm birth, late spontaneous abortion, and abruptio placentae) that are also associated with deep placentation disorders. OBJECTIVE: This study aimed to estimate the rate of placenta-mediated pregnancy complications in nulliparous women with a positive first-trimester Fetal Medicine Foundation preterm preeclampsia screening test. STUDY DESIGN: We conducted a prospective cohort study of nulliparous women recruited at 11 to 14 weeks of gestation. Maternal characteristics, mean arterial blood pressure, levels of maternal serum biomarkers (pregnancy-associated plasma protein-A, placental growth factor, and soluble fms-like tyrosine kinase-1), and mean uterine artery pulsatility index were obtained to calculate the risk of preterm preeclampsia according to the Fetal Medicine Foundation algorithm. The predicted risks were dichotomized as a positive or negative test according to 2 risk cutoffs (1 in 70 and 1 in 100). The detection rate, false-positive rate, and positive and negative predictive values were calculated for placenta-mediated complications, including preeclampsia, small for gestational age (birthweight <10th percentile), fetal death, preterm birth, and a composite outcome, including any of the foregoing. The same analyses were computed for a composite of severe outcomes, including preterm preeclampsia, severe small for gestational age (less than third percentile), and fetal death. RESULTS: We included 4575 participants with complete observations, of whom 494 (10.8%) had an estimated risk of preterm preeclampsia of ≥1 in 70 and 728 (15.9%) had a risk of ≥1 in 100. The test based on a risk cutoff of 1 in 70 could have correctly predicted up to 27% of preeclampsia, 55% of preterm preeclampsia, 18% of small for gestational age, 24% of severe small for gestational age, and 37% of fetal deaths at a 10% false-positive rate. The test based on a cutoff of 1 in 100 could have predicted correctly up to 35% of preeclampsia, 69% of preterm preeclampsia, 25% of small for gestational age, 30% of severe small for gestational age, and 53% of fetal deaths at a 15% false-positive rate. The positive predictive value of a screening test for preterm preeclampsia of ≥1 in 70 was 3% for preterm preeclampsia, 32% for the composite outcome, and 9% for the severe composite outcome. CONCLUSION: Nulliparous women with a first-trimester positive preterm preeclampsia Fetal Medicine Foundation screening test are at a higher risk of both preterm preeclampsia and other severe placenta-mediated pregnancy complications. Approximately 1 woman of 10 identified as high risk by the Fetal Medicine Foundation algorithm developed at least 1 severe placenta-mediated pregnancy complication.
Asunto(s)
Presión Arterial , Muerte Fetal , Retardo del Crecimiento Fetal/epidemiología , Paridad , Preeclampsia/epidemiología , Resultado del Embarazo/epidemiología , Nacimiento Prematuro/epidemiología , Arteria Uterina/fisiopatología , Adulto , Canadá/epidemiología , Estudios de Cohortes , Femenino , Edad Gestacional , Humanos , Recién Nacido , Recién Nacido Pequeño para la Edad Gestacional , Tamizaje Masivo , Factor de Crecimiento Placentario/metabolismo , Preeclampsia/metabolismo , Embarazo , Primer Trimestre del Embarazo , Proteína Plasmática A Asociada al Embarazo/metabolismo , Flujo Pulsátil , Medición de Riesgo , Índice de Severidad de la Enfermedad , Ultrasonografía Prenatal , Arteria Uterina/diagnóstico por imagen , Receptor 1 de Factores de Crecimiento Endotelial Vascular/metabolismoRESUMEN
OBJECTIVE: To compare the effects of 80 mg and 160 mg of aspirin, initiated in the first trimester of pregnancy, on mid-trimester uterine artery pulsatility index (UtA-PI) in women with a history of preeclampsia. METHODS: We performed a pilot double-blind randomized controlled trial. Pregnant women with a history of preeclampsia were recruited between 100/7 and 136/7 weeks gestation and randomly assigned to take either 80 or 160 mg of aspirin daily at bedtime from randomization to 356/7 weeks gestation. The primary outcome was mean UtA-PI at 22-24 weeks. Secondary outcomes included the rate of fetal growth restriction and preeclampsia, stratified as term (≥37 weeks), preterm (<37 weeks), and early-onset (<34 weeks) preeclampsia. RESULTS: A total of 107 participants were randomized, including 41 (38%) with a history of preterm preeclampsia and 16 (15%) with a history of early-onset preeclampsia. We observed no significant difference in mean UtA-PI at 22-24 weeks between the 2 groups (0.97; 95% CI 0.88-1.05 vs. 0.97; 95% CI 0.88-1.07, Pâ¯=â¯0.9). The rates of fetal growth restriction (8% vs. 2%; Pâ¯=â¯0.20); preeclampsia (12% vs. 15%; Pâ¯=â¯0.78), preterm preeclampsia (4% vs. 2%; Pâ¯=â¯0.56), and early-onset preeclampsia (0% vs. 2%; Pâ¯=â¯0.52) were similar in both groups. No serious adverse events associated with the study treatment were reported. CONCLUSION: We observed no significant difference in UtA-PI between the two doses of aspirin, but we observed low rates of fetal growth restriction and preterm and early-onset preeclampsia (all less than 5%). The benefits of aspirin for the prevention of preterm preeclampsia is probably not related to the improvement of deep placentation alone.
Asunto(s)
Aspirina/administración & dosificación , Retardo del Crecimiento Fetal/prevención & control , Inhibidores de Agregación Plaquetaria/uso terapéutico , Preeclampsia/prevención & control , Ultrasonografía Prenatal , Arteria Uterina/diagnóstico por imagen , Aspirina/uso terapéutico , Canadá/epidemiología , Relación Dosis-Respuesta a Droga , Femenino , Retardo del Crecimiento Fetal/epidemiología , Humanos , Recién Nacido , Proyectos Piloto , Inhibidores de Agregación Plaquetaria/administración & dosificación , Preeclampsia/epidemiología , Embarazo , Resultado del Embarazo , Segundo Trimestre del Embarazo , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine whether early administration of aspirin prevents severe and mild preeclampsia. STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials were performed. Studies in which women were randomized at or before 16 weeks' gestation to low-dose aspirin versus placebo or no treatment were included. The outcomes of interest were severe preeclampsia and mild preeclampsia. Pooled relative risks with their 95% confidence intervals (CIs) were calculated. RESULTS: Among 7941 citations retrieved, 352 were completely reviewed and four studies (392 women) fulfilled the inclusion criteria and were analyzed. When compared with controls, aspirin started at ≤16 weeks was associated with a significant reduction in severe (relative risk: 0.22, 95% CI: 0.08 to 0.57) but not mild (relative risk: 0.81, 95% CI: 0.33 to 1.96) preeclampsia. CONCLUSION: Low-dose aspirin initiated at or before 16 weeks reduces the risk of severe preeclampsia, but not mild preeclampsia.
Asunto(s)
Aspirina/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Preeclampsia/prevención & control , Femenino , Humanos , Embarazo , Índice de Severidad de la EnfermedadRESUMEN
Recent evidence suggests that treatment with low-dose acetylsalicylic acid (ASA) started early in pregnancy could prevent preeclampsia and intrauterine growth restriction (IUGR), two complications involving placental dysfunction. Preterm birth could also potentially be prevented, suggesting that it could share mechanisms of disease with preeclampsia and intrauterine growth restriction. Because there is new evidence that placental dysfunction can be predicted as early as in the first trimester, we argue that there is a need for randomized controlled trials of low-dose ASA for the prevention of preeclampsia, IUGR, and possibly preterm birth among nulliparous women with early indicators of placental dysfunction.
Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Aspirina/administración & dosificación , Retardo del Crecimiento Fetal/prevención & control , Preeclampsia/prevención & control , Antiinflamatorios no Esteroideos/efectos adversos , Aspirina/efectos adversos , Femenino , Humanos , Selección de Paciente , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Antenatal glucocorticoid (AGC) therapy has been associated with a decrease in respiratory distress syndrome (RDS). While preterm males remain at greater risk of RDS than females, the role of fetal sex in AGC response is not well known. OBJECTIVES: To review the available evidence regarding the effect of fetal sex in the prevention of RDS using AGC. METHOD: We conducted a systematic review and meta-analysis of RCTs to compare the effect of AGC in male and female infants with regard to the rates of RDS, intra-ventricular hemorrhage (IVH) grades III and IV, and neonatal mortality. Random effects with 95% confidence intervals were assessed in both groups and relative risks were compared using mixed regression. RESULTS: From 248 potentially eligible articles, we included eight in the analysis for a total of 1109 male and 968 female infants. Both male and female infants had a significant decrease in the risks, but no difference between the sexes was observed in terms of reduction in RDS (RR 0.50; 95% CI 0.33 to 0.77 for males, and RR 0.57; 95% CI 0.43 to 0.75 for females, P = 0.99), reduction in IVH (P = 0.98), and reduction in neonatal mortality (P = 0.43). In a sub-analysis, use of betamethasone was associated with a significant decrease in the rate of RDS in males (RR 0.29; 95% CI 0.15 to 0.57) but dexamethasone was not (RR 0.78; 95% CI 0.57 to 1.07). Conversely, dexamethasone use was significantly helpful in females (RR 0.51; 95% CI 0.32 to 0.81) but betamethasone was not (RR 0.62; 95% CI 0.38 to 1.00). CONCLUSION: The effect of AGC for prevention of RDS is similar in females and males. However, futures studies should investigate the type of AGC according to fetal/neonatal sex.
Asunto(s)
Glucocorticoides/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Femenino , Terapias Fetales , Humanos , Recién Nacido , Masculino , Embarazo , Nacimiento Prematuro , Factores SexualesRESUMEN
A growing body of evidence suggests that defective placentation may play a major role in the genesis of preterm birth, indicating that preeclampsia, intra-uterine growth restriction (IUGR), and spontaneous preterm birth can share a similar mechanism of disease. A recent meta-analysis of low-dose aspirin trials for the prevention of preeclampsia and IUGR in high-risk women demonstrated that, when started early in gestation, aspirin could prevent more than half of preeclampsia and IUGR cases but was also linked with a significant decrease of preterm births (relative risk 0.22, 95% confidence interval: 0.10-0.49). Unfortunately, most studies did not report specific data on the cause of preterm deliveries and, therefore, we could not estimate the proportion of this effect that could be related to spontaneous preterm births. Therefore, we hypothesize that low-dose aspirin could become an additional weapon in the prevention of preterm births and we suggest that further studies should be performed in this area of research.
Asunto(s)
Aspirina/administración & dosificación , Fibrinolíticos/administración & dosificación , Nacimiento Prematuro/prevención & control , Femenino , Humanos , Metaanálisis como Asunto , EmbarazoRESUMEN
BACKGROUND: Failure to reconcile patient preferences and values as well as social norms with clinical practice guidelines (CPGs) recommendations may hamper their implementation in clinical practice. However, little is known about patients and public involvement programs (PPIP) in CPGs development and implementation. This study aims at identifying what it is about PPIP that works, in which contexts are PPIP most likely to be effective, and how are PPIP assumed to lead to better CPGs development and implementation. METHODS AND DESIGN: A knowledge synthesis will be conducted in four phases. In phase one, literature on PPIP in CPGs development will be searched through bibliographic databases. A call for bibliographic references and unpublished reports will also be sent via the mailing lists of relevant organizations. Eligible publications will include original qualitative, quantitative, or mixed methods study designs reporting on a PPIP pertaining to CPGs development or implementation. They will also include documents produced by CPGs organizations to describe their PPIP. In phase two, grounded in the program's logic model, two independent reviewers will extract data to collect information on the principal components and activities of PPIP, the resources needed, the contexts in which PPIP were developed and tested, and the assumptions underlying PPIP. Quality assessment will be made for all retained publications. Our literature search will be complemented with interviews of key informants drawn from of a purposive sample of CPGs developers and patient/public representatives. In phase three, we will synthesize evidence from both the publications and interviews data using template content analysis to organize the identified components in a meaningful framework of PPIP theories. During a face-to-face workshop, findings will be validated with different stakeholder and a final toolkit for CPGs developers will be refined. DISCUSSION: The proposed research project will be among the first to explore the PPIP in CPGs development and implementation based on a wide range of publications and key informants interviews. It is anticipated that the results generated by the proposed study will significantly contribute to the improvement of the reconciliation of CPGs with patient preferences and values as well as with social norms.
RESUMEN
BACKGROUND: There are a growing number of dietary treatment options to choose from for the management of many chronic diseases. Shared decision making represents a promising approach to improve the quality of the decision making process needed for dietary choices that are informed by the best evidence and value-based. However, there are no studies reporting on theory-based approaches that foster the implementation of shared decision making in health professions allied to medicine. The objectives of this study are to explore the integration of shared decision making within real nutritional consultations, and to design questionnaires to assess dieticians' intention to adopt two specific behaviors related to shared decision making using the Theory of Planned Behavior. METHODS: Forty dieticians will audiotape one clinical encounter to explore the presence of shared decision making within the consultation. They will also participate to one of five to six focus groups that aim to identify the salient beliefs underlying the determinants of their intention to present evidence-based dietary treatment options to their patients, and clarify the values related to dietary choices that are important to their patients. These salient beliefs will be used to elaborate the items of two questionnaires. The internal consistency of theoretical constructs and the temporal stability of their measurement will be checked using the test-retest method by asking 35 dieticians to complete the questionnaire twice within a two-week interval. DISCUSSION: The proposed research project will be the first study to: provide preliminary data about the adoption of shared decision making by dieticians and theirs patients; elicit dieticians' salient beliefs regarding the intention to adopt shared decision making behaviors, report on the development of a specific questionnaire; explore dieticians' views on the implementation of shared decision making; and compare their views regarding the implementation of shared decision making in different clinical settings. It is anticipated that the results generated by the proposed research project will significantly contribute to the emergence of shared decision making in nutrition through a theory-based approach.
RESUMEN
OBJECTIVE: To evaluate the impact of a patient decision aid (PDA) regarding the use of natural health products (NHPs) at menopause on decisional conflict, knowledge of NHPs, congruence between values and choice, persistence with an option, intention to disclose the use of NHPs to a physician or a pharmacist and intention to use decision support interventions in the future. STUDY DESIGN: A randomized controlled trial in which 90 women, aged 45-64 years, facing a decision about using NHPs for menopausal symptoms, received a PDA (experimental group) or a general information brochure about menopause (control group). Main outcome Decisional conflict. Measures Women were evaluated at baseline and after a two-week period using the decisional conflict scale (DCS). Analysis of covariance was used to determine the differences between both groups on the DCS. RESULTS: Both groups experienced a statistically significant reduction on the DCS (-0.55 +/- 0.59, P < 0.0001 versus -0.52 +/- 0.73, P < 0.0001). However, there was no statistically significant difference between the groups (P = 0.32). Both groups experienced a statistically significant improvement in knowledge of NHPs (0.86 +/- 1.77, P = 0.002 versus 0.51 +/- 1.47, P = 0.031). However, there was no statistically significant difference between the groups (P = 0.162). CONCLUSION: A PDA regarding the use of NHPs for menopausal symptoms impacted favourably on women's decisional conflict, but was not superior to a general information brochure on menopause.
Asunto(s)
Técnicas de Apoyo para la Decisión , Conocimientos, Actitudes y Práctica en Salud , Menopausia , Educación del Paciente como Asunto/métodos , Participación del Paciente/estadística & datos numéricos , Fitoterapia/estadística & datos numéricos , Femenino , Humanos , Persona de Mediana Edad , Extractos Vegetales/uso terapéutico , Plantas Medicinales , Encuestas y Cuestionarios , Salud de la MujerRESUMEN
BACKGROUND: In North America, although it varies according to the specific type of acute respiratory infections (ARI), use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT) is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD) program in shared decision making, on the optimal use of antibiotics in the context of ARI. METHODS/DESIGN: This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG) in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group), or a delayed DECISION+ group (control group). Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1) and after (Phase 2) exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3). The primary outcome measures to assess the feasibility of a larger RCT include: 1) proportion of contacted FMG that agree to participate; 2) proportion of recruited physicians who participate in the DECISION+ program; 3) level of satisfaction of physicians regarding DECISION+; and 4) proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures. DISCUSSION: This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00354315.
Asunto(s)
Actitud del Personal de Salud , Protocolos Clínicos , Educación Médica Continua/métodos , Medicina Familiar y Comunitaria/educación , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Adulto , Antibacterianos/administración & dosificación , Medicina Basada en la Evidencia , Femenino , Fiebre/tratamiento farmacológico , Fiebre/etiología , Adhesión a Directriz , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Relaciones Profesional-Paciente , Quebec , Infecciones del Sistema Respiratorio/complicaciones , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To identify the decision-making needs of women about the use of natural health products (NHP) at menopause and to develop a decision aid responsive to their needs. DESIGN: A qualitative study using focus groups, key informant interviews and group consultation. Content analysis was guided by the Ottawa Decision Support Framework. METHODS: Six focus groups with menopausal women aged 45 to 64 (n = 40) and key informant interviews (n = 15; physicians, nurses, women' s advocacy group, NHP stores owners, pharmacists, policy makers) were conducted in two Canadian cities. Two groups of menopausal women (n = 11) were consulted to obtain feedback on the acceptability of the new patient decision aid. RESULTS: The most common difficult decisions identified by women were: whether or not to take NHP; which NHP to choose; and whether or not to take anything for menopausal symptoms. In addition, key informants identified the challenge of choosing between hormone therapy and NHP for menopausal symptoms. The main sources of difficulty in making these decisions were the following: (1) inadequate knowledge and unrealistic expectations associated with NHP; (2) closed mindedness of physicians to discussion about NHP; (3) conflicting opinions of others; (4) inadequate resources to support NHP decision-making (e.g., information, finances, time); and (5) menopausal symptoms interfering with decision-making (e.g., lack of sleep due to hot flashes). To facilitate decision making, participants suggested the need for information about available choices, tighter regulation of NHP by the government, and access to health professionals conversant in NHP and medical options. The patient decision aid was developed according to the International Patient Decision Aid Standards and based on women' s identified needs. Women described the aid as easy to understand and useful for considering the decisions about NHP. CONCLUSIONS: Middle-age women reported difficulty when facing decisions about the use of NHP. Many sources of difficulty could be addressed in the patient decision aid. Subsequent studies should evaluate the effect of this decision aid on the decision-making process of women.