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INTRODUCTION: Hypertensive disorders of pregnancy (HDP) affect up to 10% of all pregnancies annually and are associated with an increased risk of maternal and fetal morbidity and mortality. This guideline represents an update of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines for the management of hypertensive disorders of pregnancy 2014 and has been approved by the National Health and Medical Research Council (NHMRC) under section 14A of the National Health and Medical Research Council Act 1992. In approving the guideline recommendations, NHMRC considers that the guideline meets NHMRC's standard for clinical practice guidelines. MAIN RECOMMENDATIONS: A total of 39 recommendations on screening, preventing, diagnosing and managing HDP, especially preeclampsia, are presented in this guideline. Recommendations are presented as either evidence-based recommendations or practice points. Evidence-based recommendations are presented with the strength of recommendation and quality of evidence. Practice points were generated where there was inadequate evidence to develop specific recommendations and are based on the expertise of the working group. CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINE: This version of the SOMANZ guideline was developed in an academically robust and rigorous manner and includes recommendations on the use of combined first trimester screening to identify women at risk of developing preeclampsia, 14 pharmacological and two non-pharmacological preventive interventions, clinical use of angiogenic biomarkers and the long term care of women who experience HDP. The guideline also includes six multilingual patient infographics which can be accessed through the main website of the guideline. All measures were taken to ensure that this guideline is applicable and relevant to clinicians and multicultural women in regional and metropolitan settings in Australia and New Zealand.
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Hipertensão Induzida pela Gravidez , Humanos , Gravidez , Feminino , Austrália , Nova Zelândia , Hipertensão Induzida pela Gravidez/diagnóstico , Hipertensão Induzida pela Gravidez/terapia , Hipertensão Induzida pela Gravidez/prevenção & controle , Pré-Eclâmpsia/diagnóstico , Pré-Eclâmpsia/prevenção & controle , Pré-Eclâmpsia/terapia , Sociedades Médicas , Obstetrícia/normas , Anti-Hipertensivos/uso terapêutico , Guias de Prática Clínica como AssuntoRESUMO
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy liver disease, characterised by pruritus and increased total serum bile acids (TSBA), Australian incidence 0.6-0.7%. ICP is diagnosed by non-fasting TSBA ≥19 µmol/L in a pregnant woman with pruritus without rash without a known pre-existing liver disorder. Peak TSBA ≥40 and ≥100 µmol/L identify severe and very severe disease respectively, associated with spontaneous preterm birth when severe, and with stillbirth, when very severe. Benefit-vs-risk for iatrogenic preterm birth in ICP remains uncertain. Ursodeoxycholic acid remains the best pharmacotherapy preterm, improving perinatal outcome and reducing pruritus, although it has not been shown to reduce stillbirth.
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Female childhood, adolescent, and young adult cancer survivors have an increased risk of adverse pregnancy outcomes related to their cancer- or treatment-associated sequelae. Optimal care for childhood, adolescent, and young adult cancer survivors can be facilitated by clinical practice guidelines that identify specific adverse pregnancy outcomes and the clinical characteristics of at-risk subgroups. However, national guidelines are scarce and vary in content. Here, the International Late Effects of Childhood Cancer Guideline Harmonization Group offers recommendations for the counseling and surveillance of obstetrical risks of childhood, adolescent, and young adult survivors. A systematic literature search in MEDLINE database (through PubMed) to identify all available evidence published between January 1990 and December 2018. Published articles on pregnancy and perinatal or congenital risks in female cancer survivors were screened for eligibility. Study designs with a sample size larger than 40 pregnancies in childhood, adolescent, and young adult cancer survivors (diagnosed before the age of 25 years, not pregnant at that time) were eligible. This guideline from the International Late Effects of Childhood Cancer Guideline Harmonization Group systematically appraised the quality of available evidence for adverse obstetrical outcomes in childhood, adolescent, and young adult cancer survivors using Grading of Recommendations Assessment, Development, and Evaluation methodology and formulated recommendations to enhance evidence-based obstetrical care and preconception counseling of female childhood, adolescent, and young adult cancer survivors. Healthcare providers should discuss the risk of adverse obstetrical outcomes based on cancer treatment exposures with all female childhood, adolescent, and young adult cancer survivors of reproductive age, before conception. Healthcare providers should be aware that there is no evidence to support an increased risk of giving birth to a child with congenital anomalies (high-quality evidence). Survivors treated with radiotherapy to volumes exposing the uterus and their healthcare providers should be aware of the risk of adverse obstetrical outcomes such as miscarriage (moderate-quality evidence), premature birth (high-quality evidence), and low birthweight (high-quality evidence); therefore, high-risk obstetrical surveillance is recommended. Cardiomyopathy surveillance is reasonable before pregnancy or in the first trimester for all female survivors treated with anthracyclines and chest radiation. Female cancer survivors have increased risks of premature delivery and low birthweight associated with radiotherapy targeting the lower body and thereby exposing the uterus, which warrant high-risk pregnancy surveillance.
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Sobreviventes de Câncer , Aconselhamento , Guias de Prática Clínica como Assunto , Cuidado Pré-Concepcional/normas , Complicações na Gravidez/psicologia , Adolescente , Criança , Feminino , Humanos , Gravidez , Complicações na Gravidez/prevenção & controle , Adulto JovemRESUMO
BACKGROUND: Specialised preterm birth clinics care for women at high risk of spontaneous preterm birth. This systematic review assesses current practice within preterm birth clinics globally. METHODS: A comprehensive search strategy was used to identify all studies on preterm birth clinics on the MEDLINE, Embase, PsycINFO, CENTRAL and CINAHL databases. There were no restrictions to study design. Studies were limited to the English language and publications from 1998 onwards. Two reviewers assessed studies for inclusion, performed data extraction and reviewed methodological quality. Primary outcomes were referral criteria, investigations and interventions offered in preterm birth clinics. Secondary outcomes were the timing of planned first and last appointments and frequency of review. RESULTS: Thirty-two records fulfilled eligibility criteria and 20 studies were included in the main analysis following grouping of records describing the same study or clinic. Studies were of mixed study design and methodological quality. A total of 39 clinics were described; outcome data was not available for all clinics. Referral criteria included previous spontaneous preterm birth (38/38, 100%), previous mid-trimester loss (34/38, 89%) and previous cervical surgery (33/38, 87%). All clinics offered transvaginal cervical length scans. Additional investigations varied, including urogenital swabs (16/28, 57%) and fetal fibronectin (8/28, 29%). The primary treatment of choice for a sonographic short cervix was cervical cerclage in 10/33 (30%) clinics and vaginal progesterone in 6/33 (18%), with 10/33 (30%) using multiple first-line options and 6/33 (18%) using a combination of treatments. The majority of clinics planned timing of first review for 12-16 weeks (30/35, 86%) and the frequency of review was usually determined by clinical findings (18/24, 75%). There was a wide variation in gestational age at clinic discharge between 24 and 37 weeks. CONCLUSIONS: There is variation in the referral criteria, investigations and interventions offered in preterm birth clinics and in the timing and frequency of review. Consistency in practice may improve with the introduction of consensus guidelines and national preterm birth prevention programmes. TRIAL REGISTRATION: Systematic review registration number: CRD42019131470.
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Ambulatório Hospitalar/organização & administração , Assistência Perinatal/organização & administração , Gravidez de Alto Risco , Nascimento Prematuro/prevenção & controle , Prevenção Secundária/organização & administração , Adulto , Medida do Comprimento Cervical/métodos , Protocolos Clínicos , Feminino , Humanos , Recém-Nascido , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Resultado da Gravidez , Nascimento Prematuro/terapiaRESUMO
In recent years, significant improvements in survival and survival-free of major morbidity in babies born at 23+0 to 24+6 weeks of gestation have led to a more pro-active approach to resuscitation at these peri-viable gestations. Antenatal counselling and interventions, intrapartum care and postnatal advice should be part of the package of care provided to optimise outcomes for these babies and their families. This observational study assesses the perinatal care provided to mothers and their babies who were born at 23 and 24 weeks of gestations over a two-year period at a tertiary maternity hospital in New Zealand.
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Lactente Extremamente Prematuro , Assistência Perinatal/normas , Nascimento Prematuro/mortalidade , Adulto , Parto Obstétrico/estatística & dados numéricos , Feminino , Idade Gestacional , Maternidades , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , Nova Zelândia , Taxa de SobrevidaRESUMO
BACKGROUND: A greater understanding of the risk factors for spontaneous preterm birth and the importance of risk stratification to guide interventions has led to the introduction of preterm birth prevention clinics. AIM: To evaluate the experience and outcomes of the first specialised preterm birth clinic in New Zealand. MATERIALS AND METHODS: This observational study reviewed pregnancies cared for in a preterm birth clinic from 2013 to 2018. Cases were identified and data collected from a maternity database and electronic medical records. Analysis was by referral type. RESULTS: A total of 423 cases were included; 309 elective and 22 acute referrals in pregnancy, and 92 consultations outside pregnancy. For those referred electively in pregnancy, 138/309 (44.7%) fulfilled multiple referral criteria, and 57/309 (18.4%) had ≥2 previous spontaneous preterm births or second trimester losses. Excluding five pregnancies with first trimester miscarriage, 77/304 (25.3%) were managed with a history-indicated cerclage (11 placed pre-conception) and 217/304 (71.4%) had cervical surveillance as primary management, of which 133 (61.3%) did not require treatment. The remaining had treatment for a short cervix; 37 (17.0%) received an ultrasound-indicated cerclage only, 21 (9.7%) vaginal progesterone only and 26 (12.0%) both. Five women (1.6%) had a second trimester loss at 13+0 -19+6 and 58/297 (19.5%) had a spontaneous preterm birth at 20+0 -36+6 weeks. The 'take home baby' rate was 95.4%. CONCLUSIONS: Pregnancy outcomes were similar to those reported by other preterm birth prevention clinics. The majority of women who received cervical surveillance as primary management were able to avoid additional treatment.
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Cerclagem Cervical/métodos , Colo do Útero/cirurgia , Nascimento Prematuro/epidemiologia , Adulto , Feminino , Humanos , Recém-Nascido , Nova Zelândia/epidemiologia , Gravidez , Resultado da GravidezRESUMO
BACKGROUND: Hypertensive disorders of pregnancy are a major contributor to death and disability for pregnant women and their infants. The diagnosis of preeclampsia by using blood pressure and proteinuria is of limited use because they are tertiary, downstream features of the disease. Placental growth factor (PlGF) is an angiogenic factor, a secondary marker of associated placental dysfunction in preeclampsia, with known low plasma concentrations in the disease. METHODS AND RESULTS: In a prospective multicenter study, we studied the diagnostic accuracy of low plasma PlGF concentration (<5th centile for gestation, Alere Triage assay) in women presenting with suspected preeclampsia between 20 and 35 weeks' gestation (and up to 41 weeks' gestation as a secondary analysis). The outcome was delivery for confirmed preeclampsia within 14 days. Of 625 women, 346 (55%) developed confirmed preeclampsia. In 287 women enrolled before 35 weeks' gestation, PlGF <5th centile had high sensitivity (0.96; 95% confidence interval, 0.89-0.99) and negative predictive value (0.98; 0.93-0.995) for preeclampsia within 14 days; specificity was lower (0.55; 0.48-0.61). Area under the receiver operating characteristic curve for low PlGF (0.87, standard error 0.03) for predicting preeclampsia within 14 days was greater than all other commonly used tests, singly or in combination (range, 0.58-0.76), in women presenting with suspected preeclampsia (P<0.001 for all comparisons). CONCLUSIONS: In women presenting before 35 weeks' gestation with suspected preeclampsia, low PlGF has high sensitivity and negative predictive value for preeclampsia within 14 days, is better than other currently used tests, and presents an innovative adjunct to management of such women.
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Química Clínica/normas , Pré-Eclâmpsia/sangue , Pré-Eclâmpsia/diagnóstico , Proteínas da Gravidez/sangue , Adulto , Biomarcadores/sangue , Feminino , Seguimentos , Humanos , Fator de Crescimento Placentário , Pré-Eclâmpsia/epidemiologia , Valor Preditivo dos Testes , Gravidez , Estudos Prospectivos , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e EspecificidadeRESUMO
There is increasing evidence that pre-eclampsia, a principal cause of maternal morbidity, may also be a risk factor for future cardiovascular and cerebrovascular events. This review aimed to assess the current evidence and quantify the risks of cardiovascular disease (CVD), cerebrovascular events and hypertension associated with prior diagnosis of pre-eclampsia. Medline and Embase were searched with no language restrictions, as were core journals and reference lists from reviews up until January 2012. Case-control and cohort studies which reported cardiovascular and cerebrovascular diseases or hypertension diagnosed more than 6 weeks postpartum, in women who had a history of pre-eclampsia relative to women who had unaffected pregnancies, were included. Fifty articles were included in the systematic review and 43 in the meta-analysis. Women with a history of pre-eclampsia or eclampsia were at significantly increased odds of fatal or diagnosed CVD [odds ratio (OR) = 2.28, 95% confidence interval (CI): 1.87, 2.78], cerebrovascular disease (OR = 1.76, 95% CI 1.43, 2.21) and hypertension [relative risk (RR) = 3.13, 95% CI 2.51, 3.89]. Among pre-eclamptic women, pre-term delivery was not associated with an increased risk of a future cardiovascular event (RR = 1.32, 95% CI 0.79, 2.22). Women diagnosed with pre-eclampsia are at increased risk of future cardiovascular or cerebrovascular events, with an estimated doubling of odds compared to unaffected women. This has implications for the follow-up of all women who experience pre-eclampsia, not just those who deliver pre-term. This association may reflect shared common risk factors for both pre-eclampsia and cardiovascular and cerebrovascular disease.
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Doenças Cardiovasculares/etiologia , Transtornos Cerebrovasculares/etiologia , Hipertensão/complicações , Pré-Eclâmpsia , Feminino , Humanos , Hipertensão/diagnóstico , Morbidade , Gravidez , Fatores de Risco , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: To assess the psychological well-being of pregnant women at increased risk of spontaneous preterm birth, and the impact of care from a preterm birth clinic. DESIGN: Single-centre longitudinal cohort study over 1 year, 2018-2019. SETTING: Tertiary maternity hospital in Auckland, New Zealand. PARTICIPANTS: Pregnant women at increased risk of spontaneous preterm birth receiving care in a preterm birth clinic. INTERVENTION: Participants completed three sets of questionnaires (State-Trait Anxiety Inventory, Edinburgh Postnatal Depression Scale, and 36-Item Short Form Survey)-prior to their first, after their second, and after their last clinic appointments. Study-specific questionnaires explored pregnancy-related anxiety and perceptions of care. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the mean State-Anxiety score. Secondary outcomes included depression and quality of life measures. RESULTS: 73/97 (75.3%) eligible women participated; 41.1% had a previous preterm birth, 31.5% a second trimester loss and 28.8% cervical surgery; 20.6% had a prior mental health condition. 63/73 (86.3%) women completed all questionnaires. The adjusted mean state-anxiety score was 39.0 at baseline, which decreased to 36.5 after the second visit (difference -2.5, 95% CI -5.5 to 0.5, p=0.1) and to 32.6 after the last visit (difference -3.9 from second visit, 95% CI -6.4 to -1.5, p=0.002). Rates of anxiety (state-anxiety score >40) and depression (Edinburgh Postnatal Depression Scale score >12) were 38.4%, 34.8%, 19.0% and 13.7%, 8.7%, 9.5% respectively, at the same time periods. Perceptions of care were favourable; 88.9% stated the preterm birth clinic made them significantly or somewhat less anxious and 87.3% wanted to be seen again in a future pregnancy. CONCLUSIONS: Women at increased risk of spontaneous preterm birth have high levels of anxiety. Psychological well-being improved during the second trimester; women perceived that preterm birth clinic care reduced pregnancy-related anxiety. These findings support the ongoing use and development of preterm birth clinics.
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Nascimento Prematuro , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Estudos Longitudinais , Masculino , Gravidez , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/psicologia , Estudos Prospectivos , Qualidade de VidaRESUMO
BACKGROUND: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach. METHODS: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat. DISCUSSION: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018.
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Aborto Espontâneo , Cerclagem Cervical , Nascimento Prematuro , Aborto Espontâneo/diagnóstico , Aborto Espontâneo/etiologia , Aborto Espontâneo/prevenção & controle , Colo do Útero , Criança , Feminino , Humanos , Recém-Nascido , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Gravidez , Nascimento Prematuro/etiologia , Nascimento Prematuro/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , NatimortoRESUMO
[This corrects the article DOI: 10.1186/s10397-017-1034-0.].
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BACKGROUND: Fresh frozen cadaver training has been proposed as a better model than virtual reality simulators in laparoscopy training. We aimed to explore the relationship between cadaveric surgical training and increased surgical confidence.To determine feasibility, we devised two 1-day cadaveric surgical training days targeted at trainees in obstetrics and gynaecology. Seven defined surgical skills were covered during the course of the day. The relationship between surgical training and surgical confidence was explored using both quantitative (confidence scores) and qualitative tools (questionnaires). RESULTS: Participants rated a consistent improvement in their level of confidence after the training. They universally found the experience positive and three overarching themes emerged from the qualitative analysis including self-concept, social persuasion and stability of task. CONCLUSIONS: It is pragmatically feasible to provide procedure-specific cadaveric surgical training alongside supervised clinical training. This small, non-generalisable study suggests that cadaveric training may contribute to an increase in surgical self-confidence and efficacy. This will form the basis of a larger study and needs to be explored in more depth with a larger population.
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Hypertensive disorders during pregnancy result in substantial maternal morbidity and are a leading cause of maternal deaths worldwide. Self-monitoring of blood pressure (BP) might improve the detection and management of hypertensive disorders of pregnancy, but few data are available, including regarding appropriate thresholds. This systematic review and individual patient data analysis aimed to assess the current evidence on differences between clinic and self-monitored BP through pregnancy. MEDLINE and 10 other electronic databases were searched for articles published up to and including July 2016 using a strategy designed to capture all the literature on self-monitoring of BP during pregnancy. Investigators of included studies were contacted requesting individual patient data: self-monitored and clinic BP and demographic data. Twenty-one studies that utilized self-monitoring of BP during pregnancy were identified. Individual patient data from self-monitored and clinic readings were available from 7 plus 1 unpublished articles (8 studies; n=758) and 2 further studies published summary data. Analysis revealed a mean self-monitoring clinic difference of ≤1.2 mm Hg systolic BP throughout pregnancy although there was significant heterogeneity (difference in means, I2 >80% throughout pregnancy). Although the overall population difference was small, levels of white coat hypertension were high, particularly toward the end of pregnancy. The available literature includes no evidence of a systematic difference between self and clinic readings, suggesting that appropriate treatment and diagnostic thresholds for self-monitoring during pregnancy would be equivalent to standard clinic thresholds.
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Determinação da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/métodos , Pressão Sanguínea/fisiologia , Hipertensão/fisiopatologia , Complicações Cardiovasculares na Gravidez/fisiopatologia , Hipertensão do Jaleco Branco/fisiopatologia , Feminino , Humanos , Gravidez , Resultado da GravidezRESUMO
BACKGROUND: The National Institute for Health and Care Excellence (NICE) guidelines highlighted the need for 'large, high-quality prospective studies comparing the various methods of measuring proteinuria in women with new-onset hypertensive disorders during pregnancy'. OBJECTIVES: The primary objective was to evaluate quantitative assessments of spot protein-creatinine ratio (SPCR) and spot albumin-creatinine ratio (SACR) in predicting severe pre-eclampsia (PE) compared with 24-hour urine protein measurement. The secondary objectives were to investigate interlaboratory assay variation, to evaluate SPCR and SACR thresholds in predicting adverse maternal and fetal outcomes and to assess the cost-effectiveness of these models. DESIGN: This was a prospective diagnostic accuracy cohort study, with decision-analytic modelling and a cost-effectiveness analysis. SETTING: The setting was 36 obstetric units in England, UK. PARTICIPANTS: Pregnant women (aged ≥ 16 years), who were at > 20 weeks' gestation with confirmed gestational hypertension and trace or more proteinuria on an automated dipstick urinalysis. INTERVENTIONS: Women provided a spot urine sample for protein analysis (the recruitment sample) and were asked to collect a 24-hour urine sample, which was stored for secondary analysis. A further spot sample of urine was taken immediately before delivery. MAIN OUTCOME MEASURES: Outcome data were collected from hospital records. There were four index tests on a spot sample of urine: (1) SPCR test (conducted at the local laboratory); (2) SPCR test [conducted at the central laboratory using the benzethonium chloride (BZC) assay]; (3) SPCR test [conducted at the central laboratory using the pyrogallol red (PGR) assay]; and (4) SACR test (conducted at the central laboratory using an automated chemistry analyser). The comparator tests on 24-hour urine collection were a central test using the BZC assay and a central test using the PGR assay. The primary reference standard was the NICE definition of severe PE. Secondary reference standards were a clinician diagnosis of severe PE, which is defined as treatment with magnesium sulphate or with severe PE protocol; adverse perinatal outcome; one or more of perinatal or infant mortality, bronchopulmonary dysplasia, necrotising enterocolitis or grade III/IV intraventricular haemorrhage; and economic cost and outcomes. Health service data on service use and costs followed published economic models. RESULTS: In total, 959 women were available for primary analysis and 417 of them had severe PE. The diagnostic accuracy of the four assays on spot urine samples against the reference standards was similar. The three SPCR tests had sensitivities in excess of 90% at prespecified thresholds, with poor specificities and negative likelihood ratios of ≥ 0.1. The SACR test had a significantly higher sensitivity of 99% (confidence interval 98% to 100%) and lower specificity. Receiver operating characteristic (ROC) curves were similar (area under ROC curve between 0.87 and 0.89); the area under the central laboratory's SACR curve was significantly higher (p = 0.004). The central laboratory's SACR test was the most cost-effective option, generating an additional 0.03 quality-adjusted life-years at an additional cost of £45.07 compared with the local laboratory's SPCR test. The probabilistic analysis showed it to have a 100% probability of being cost-effective at the standard willingness-to-pay threshold recommended by NICE. LIMITATIONS: Implementation of NICE guidelines has led to an increased intervention rate in the study population that affected recruitment rates and led to revised sample size calculations. CONCLUSIONS: Evidence from this clinical study does not support the recommendation of 24-hour urine sample collection in hypertensive pregnant women. The SACR test had better diagnostic performance when predicting severe pre-eclampsia. All four tests could potentially be used as rule-out tests for the NICE definition of severe PE. FUTURE WORK: Testing SACR at a threshold of 8 mg/mmol should be studied as a 'rule-out' test of proteinuria. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82607486. FUNDING: This project was funded by the National Institute Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 61. See the NIHR Journals Library website for further project information.
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Albuminúria/diagnóstico , Creatinina , Testes Diagnósticos de Rotina/normas , Pré-Eclâmpsia/diagnóstico , Proteinúria/diagnóstico , Adulto , Albuminúria/urina , Análise Custo-Benefício , Creatinina/urina , Inglaterra , Feminino , Humanos , Pré-Eclâmpsia/urina , Gravidez , Estudos Prospectivos , Proteinúria/urina , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To evaluate 47 biomarkers (selected from the current medical literature), in isolation or in combination with placental growth factor (PlGF), to determine the need for delivery within 14 days, in women presenting with suspected preterm preeclampsia. METHODS: In a prospective, multicenter observational study, 47 biomarkers were measured in 423 women presenting with suspected preterm preeclampsia (in two prespecified groups: group 1 at less than 35 weeks of gestation and group 2 presenting between 35 0/7 and 36 6/7 weeks of gestation) to evaluate their ability to determine the primary endpoint: preeclampsia requiring delivery within 14 days. Using factor analysis and stepwise logistic regression, we sought one or more additional biomarkers for optimal determination of the primary endpoint. RESULTS: In women presenting at less than 35 weeks of gestation (n=286), the best performing combination of PlGF, podocalyxin, endoglin, procalcitonin (receiver operating curve [ROC] area 0.90, 95% confidence interval [CI] 0.86-0.93) was not statistically better than PlGF alone (ROC 0.87, 95% CI 0.83-0.92; P=.43) for preeclampsia requiring delivery within 14 days. Two other single markers had test performance that was not significantly different to PlGF (soluble fms-like tyrosine kinase-1 [sFlt-1] ROC 0.83, 95% CI 0.78-0.88; endoglin ROC 0.83, 95% CI 0.79-0.88). Similar findings were found in women presenting between 35 0/7 and 36 6/7 weeks of gestation (n=137): ROC for PlGF alone 0.75 (95% CI 0.67-0.83); ROC for PlGF, cystatin, pregnancy-associated plasma protein A in combination 0.81 (95% CI 0.74-0.88; P=.40). CONCLUSION: This study supports the growing body of evidence that a single angiogenesis-related biomarker (PlGF, sFlt-1, or endoglin) alone represents a useful diagnostic test for women presenting with suspected preterm preeclampsia.
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Fator de Crescimento Placentário/sangue , Pré-Eclâmpsia/sangue , Pré-Eclâmpsia/diagnóstico , Adulto , Área Sob a Curva , Biomarcadores/sangue , Calcitonina/sangue , Cistatinas/sangue , Parto Obstétrico , Endoglina/sangue , Feminino , Idade Gestacional , Humanos , Gravidez , Proteína Plasmática A Associada à Gravidez/metabolismo , Estudos Prospectivos , Curva ROC , Sialoglicoproteínas/sangue , Fatores de Tempo , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangueRESUMO
OBJECTIVE: To determine what threshold for proteinuria could best predict clinical outcome and whether this threshold could be applied universally to any biochemical assay. DESIGN: A prospective observational study of hypertensive pregnancies referred for further assessment after in a UK University hospital (n=197). Twenty-four hour urine protein was measured by two different assays [benzethonium chloride assay (BCA) and Bradford assay]. The differences between the two assays were calculated from Receiver Operating Characteristic (ROC) curves. Commonly used thresholds for defining preeclampsia (0.3 and 0.5 g/24 hours) were explored for both assays for the prediction of adverse clinical outcomes (severe hypertension, Birthweight<10th percentile, preterm delivery, and a composite biochemical/haematological derangement). RESULTS: The two assays are not equivalent. The prevalence of>300 mg/24 hour proteinuria and, hence, the prevalence of preeclampsia differed between the two assays. ROC curve analysis demonstrates that the two assays are similar in terms of overall performance as predictive tests. However the threshold of 300 mg/24 hours performs poorly as a predictor of clinical risk. Likelihood ratios (LR) for the BCA at the 300 mg/L threshold for each clinical outcome do not achieve statistical significance. At the 500 mg/L threshold, the LR+for the BCA assay does achieve statistical significance for severe hypertension (LR+:1.51 95% CI 0.99-2.28) and for birthweight<10th percentile (LR+:1.72 95% CI 1.11-2.66). For the Bradford assay at the 300 mg/24 hour threshold, the LR+does achieve statistical significance for birthweight<10th percentile (LR+:1.71 95% CI 1.41-4.31). However, at the 500 mg/24 hour threshold, the LR+is significant for severe hypertension (LR+:2.15 95% CI 1.07-4.34), birthweight<10th percentile (LR+:2.79 95% CI 1.4-5.54) and biochemical disease (LR+:2.47 95% CI 1.22-5.01). CONCLUSIONS: This study suggests that thresholds for proteinuria need to be higher (possibly>or=0.5 g/24 hours) and there is the need for a "gold standard" proteinuria assay against which all other measures of quantification can be assessed.
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Hipertensão Induzida pela Gravidez/urina , Proteinúria/urina , Urinálise/métodos , Adulto , Feminino , Humanos , Valor Preditivo dos Testes , Gravidez , Resultado da Gravidez , Estudos Prospectivos , Curva ROC , Sensibilidade e EspecificidadeRESUMO
Pre-eclampsia leads to disturbed fetal organ development, including metabolic syndrome, attributed to altered pituitary-adrenal feedback loop. We measured cortisol metabolites in infants born from pre-eclamptic and normotensive women and hypothesised that glucocorticoid exposure would be exaggerated in the former. Twenty-four hour urine was collected from infants at months 3 and 12. Cortisol metabolites and apparent enzyme activities were analysed by gas chromatography-mass spectrometry. From 3 to 12 months, excretion of THS, THF and pregnandiol had risen in both groups; THF also rose in the pre-eclamptic group. No difference was observed with respect to timing of the visit or to hypertensive status for THE or total F metabolites (P>0.05). All apparent enzymes activities, except 17α-hydroxylase, were lower in infants at 12 compared to 3 months in the normotensive group. In the pre-eclamptic group, only 11ß-HSD activities were lower at 12 months.17α-hydroxylase and 11ß-HSD activities of tetrahydro metabolites were higher in the pre-eclamptic group at 3 months (P<0.05). 11ß-hydroxylase activity increased in the pre-eclamptic group at 12 months. Cortisol excretion, determined by increased 11ß-hydroxylase, compensates for high 11ß-HSD-dependent cortisol degradation at 3 months and at 12 months counterbalances the reduced cortisol substrate availability in infants born from pre-eclamptic mothers.
RESUMO
OBJECTIVE: To estimate the accuracy of point-of-care dipstick urinalysis in predicting significant proteinuria in pregnancy. DATA SOURCES: Literature from 1970 to February 2002 was identified via 1). general bibliographic databases, that is, MEDLINE and EMBASE, 2). Cochrane Library and relevant specialist register of the Cochrane Collaboration, and 3). checking the reference lists of known primary and review articles. METHODS OF STUDY SELECTION: Studies were selected if the accuracy of dipstick urinalysis techniques in predicting total protein excretion was estimated compared with a reference standard (laboratory estimation of protein excretion). The tests included visually read color-change dipsticks and automated dipstick urinalysis. Study selection, quality assessment, and data abstraction were performed independently and in duplicate. TABULATION, INTEGRATION, AND RESULTS: Data from selected studies were abstracted as 2 x 2 tables comparing the test result with the reference standard. Test accuracy was expressed as likelihood ratios. Summary likelihood ratios were generated as measures of diagnostic accuracy to determine posttest probabilities. The electronic search produced 1543 citations. After independent review of published articles, a total of 34 articles was obtained for further scrutiny, and 7 studies were considered eligible for inclusion in the review. The 6 studies evaluating visual dipstick urinalysis produced a pooled positive likelihood ratio of 3.48 (95% confidence interval 1.66, 7.27) and a pooled negative likelihood ratio of 0.6 (95% confidence interval 0.45, 0.8) for predicting 300 mg/24-hour proteinuria at the 1+ or greater threshold. CONCLUSION: The accuracy of dipstick urinalysis with a 1+ threshold in the prediction of significant proteinuria is poor and therefore of limited usefulness to the clinician. Accuracy may be improved at higher thresholds (greater than 1+ proteinuria), but available data are sparse and of poor methodological quality. Therefore, it is not possible to make meaningful inferences about accuracy at higher urine dipstick thresholds. There is an urgent need for research in this area of common obstetric practice.
Assuntos
Complicações na Gravidez/diagnóstico , Proteinúria/diagnóstico , Urinálise , Feminino , Humanos , Valor Preditivo dos Testes , Gravidez , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To determine the accuracy of the DCA 2000 albumin/creatinine ratio urinanalyzer (Bayer Corp., Elkhart, IN) in uncomplicated pregnancy and preeclampsia. METHODS: This was a prospective observational study in a large teaching maternity hospital. Ninety one uncomplicated pregnant women and 100 women referred for assessment of de novo hypertension in pregnancy had albumin concentrations, creatinine concentrations, and albumin/creatinine ratios (ACR) compared between the DCA 2000 and the laboratory gold standard assays (Dade Dimension clinical chemistry autoanalyzer), for both early morning urines (EMU) and 24-hr urine collections. RESULTS: The interassay and intra-assay variability for the DCA 2000 were less than 5.1%. In uncomplicated pregnancy the mean difference in ACR between the DCA 2000 and the laboratory assay was 0.08 mg/mmol (SD 0.28; 95% limits of agreement, -0.47, 0.63) for EMU and 0.06 (SD 0.23; 95% limits of agreement, -0.39, 0.51) for 24-hr samples. In the hypertensive cohort the ACR mean differences were -0.82 (SD 7.13; 95% limits of agreement, -14.79, 13.15) for EMU and -0.76 (SD 4.14; 95% limits of agreement, -8.87, 7.35) for 24-hr samples. The mean differences between assays in the hypertensive group had broader 95% limits of agreement due to greater variability in the samples with high albumin concentrations (>40 mg/L). CONCLUSIONS: The DCA 2000 is accurate for the measurement of albumin creatinine ratios in the uncomplicated pregnant population. In the hypertensive population the DCA 2000 remains accurate though when the albumin concentration is greater than 40 mg/L the 95% limits of agreement are broader. We would recommend that all other automated urinalysis devices be validated by similar protocols to allow meaningful comparisons of accuracy.