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1.
Anaesthesia ; 77(2): 175-184, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34671971

RESUMO

There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent, leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment was 32% (95%CI 23-41%) in the intervention group vs. 81% (95%CI 70-90%) in the control group. The proportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control (31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference -0.6 units, 95%CI -1.2 to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3-1.1); and intensive care admissions (odds ratio 0.4, 95%CI 0.1-1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation.


Assuntos
Transfusão de Sangue/métodos , Fator VIII/administração & dosagem , Fibrinogênio/administração & dosagem , Gravidade do Paciente , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , Adulto , Análise por Conglomerados , Feminino , Humanos , Projetos Piloto , Gravidez
2.
BJOG ; 128(1): 37-44, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32570294

RESUMO

BACKGROUND: Adnexal torsion (AT), a serious gynaecological emergency, often presents with non-specific symptoms leading to delayed diagnosis. OBJECTIVE: To compare the test accuracy of ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) to diagnose AT. SEARCH STRATEGY: We searched EMBASE, MEDLINE and Cochrane CENTRAL until December 2019. SELECTION CRITERIA: Studies reporting on the accuracy of any imaging modality (Index Test) in female patients (paediatric and adult) suspected of AT compared with surgical diagnosis and/or standard clinical/radiological follow-up period until resolution of symptoms (Reference Standard). DATA COLLECTION AND ANALYSIS: We assessed study quality using QUADAS-2. We conducted test accuracy meta-analysis using a univariate model or a hierarchical model. MAIN RESULTS: We screened 3836 citations, included 18 studies (1654 women, 665 cases), and included 15 in the meta-analyses. Ultrasound pooled sensitivity (n = 12, 1187 women) was 0.79 (95% CI 0.63-0.92) and specificity was 0.76 (95% CI 0.54-0.93), with negative and positive likelihood ratios of 0.29 (95% CI 0.13-0.66) and 4.35 (95% CI 2.03-9.32), respectively. Using Doppler with ultrasound (n = 7, 845 women) yielded similar sensitivity (0.80, 95% CI 0.67-0.93) and specificity (0.88, 95% CI 0.72-1.00). For MRI (n = 3, 99 women), the pooled sensitivity was 0.81 (95% CI 0.63-0.91) and specificity was 0.91 (95% CI 0.80-0.96). A meta-analysis for CT was not possible with two case-control studies and one cohort study (n = 3, 232 women). Its sensitivity range was 0.74-0.95 and specificity was 0.80-0.90. CONCLUSIONS: Ultrasound has good performance as a first-line diagnostic test for suspected AT. Magnetic resonance imaging could offer improved specificity to investigate complex ovarian morphology, but more evidence is needed. TWEETABLE ABSTRACT: To investigate adnexal torsion, ultrasound is a good first-line diagnostic test with a pooled sensitivity of 0.79 and specificity of 0.76.


Assuntos
Torção Ovariana/diagnóstico por imagem , Feminino , Humanos , Imageamento por Ressonância Magnética , Sensibilidade e Especificidade , Tomografia Computadorizada por Raios X , Ultrassonografia
3.
BJOG ; 128(1): 87-95, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32575151

RESUMO

OBJECTIVE: To evaluate the effectiveness of virtual reality as a distraction technique in the management of acute pain and anxiety during outpatient hysteroscopy. DESIGN: Parallel group, prospective randomised controlled trial. SETTING: UK University Hospital. METHODS: Forty consenting, eligible women were randomised to virtual reality intervention (immersive video content as a distraction method) or standard care during outpatient hysteroscopy from August to October 2018. MAIN OUTCOME MEASURES: Pain and anxiety outcomes were measured as a numeric rating score (scale 0-10). RESULTS: Compared with standard care, women with virtual reality intervention experienced less average pain (score 6.0 versus 3.7, mean difference 2.3, 95% CI 0.61-3.99, P = 0.009) and anxiety (score 5.45 versus 3.3, mean difference 2.15, 95% CI 0.38-3.92, P = 0.02). CONCLUSION: Virtual reality was effective in reducing pain and anxiety during outpatient hysteroscopy in a mixed-methods randomised control trial. Its wide potential role in ambulatory gynaecological procedures needs further evaluation. TWEETABLE ABSTRACT: Virtual reality can be used as a part of a multimodal strategy to reduce acute pain and anxiety in patients undergoing outpatient hysteroscopy.


Assuntos
Histeroscopia , Pacientes Ambulatoriais , Dor/prevenção & controle , Realidade Virtual , Adulto , Feminino , Hospitais Universitários , Humanos , Medição da Dor , Estudos Prospectivos , Resultado do Tratamento
4.
BJOG ; 127(4): 478-488, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31715077

RESUMO

OBJECTIVE: Women with pre-eclampsia have elevated circulating levels of soluble fms-like tyrosine kinase-1 (sFlt-1). Statins can reduce sFlt-1 from cultured cells and improve pregnancy outcome in animals with a pre-eclampsia-like syndrome. We investigated the effect of pravastatin on plasma sFlt-1 levels during pre-eclampsia. DESIGN: Blinded (clinician and participant), proof of principle, placebo-controlled trial. SETTING: Fifteen UK maternity units. POPULATION: We used a minimisation algorithm to assign 62 women with early-onset pre-eclampsia (24+0 -31+6  weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth. PRIMARY OUTCOME: Difference in mean plasma sFlt-1 levels over the first 3 days following randomisation. RESULTS: The difference in the mean maternal plasma sFlt-1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI -1175 to 592; P = 0.5), and over days 1-14 was 48 pg/ml (95% CI -1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50-1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5-14 days) for the pravastatin group and 7 days (IQR 4-11 days) for the placebo group. There were three perinatal deaths in the placebo-treated group and no deaths or serious adverse events attributable to pravastatin. CONCLUSIONS: We found no evidence that pravastatin lowered maternal plasma sFlt-1 levels once early-onset pre-eclampsia had developed. Pravastatin appears to have no adverse perinatal effects. TWEETABLE ABSTRACT: Pravastatin does not improve maternal plasma sFlt-1 or placental growth factor levels following a diagnosis of early preterm pre-eclampsia #clinicaltrial finds.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Pravastatina/administração & dosagem , Pré-Eclâmpsia/tratamento farmacológico , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangue , Adulto , Método Duplo-Cego , Feminino , Idade Gestacional , Humanos , Pré-Eclâmpsia/sangue , Gravidez , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/efeitos dos fármacos
5.
BJOG ; 126(6): 778-783, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30575266

RESUMO

OBJECTIVE: To evaluate if the experience of psychological intimate partner violence (IPV) adversely affects breastfeeding rates. DESIGN: A cohort study. SETTING: Maternities in 15 public hospitals, drawn using cluster sampling of obstetric services in Andalusia, Spain. POPULATION: A total of 779 consecutive mothers receiving antenatal care including ultrasound and giving birth during February-June 2010. METHODS: Trained midwives gathered IPV data using the Index of Spouse Abuse validated in the Spanish language (score ranges: 0-100, higher scores reflect more severe IPV; cut-off: psychological IPV = 25). Sociodemographic data including lack of kin support, and obstetric and neonatal outcomes were collected. Multivariate logistic regression estimated adjusted odds ratios (aOR), with 95% confidence intervals (CI), of the relationship between psychological IPV and breastfeeding, controlling for sociodemographic characteristics and obstetric complications. MAIN OUTCOME MEASURE: Breastfeeding avoidance defined as lack of breastfeeding or pumping of breast milk to feed the new baby in the immediate post-partum period. RESULTS: Response rate was 92.2%. A total of 70% (n = 545) of women initiated breastfeeding. Psychological IPV, reported by 21.0% (n = 151), increased the odds of breastfeeding avoidance (aOR = 2.0; 95% CI = 1.2-3.3) adjusting for the presence of obstetric complications (aOR = 1.6; 95% CI = 1.0-2.4). CONCLUSIONS: Mothers with psychological IPV avoid breastfeeding. Clinicians should be aware of the risks to infant arising from this deficiency due to IPV in pregnancy. TWEETABLE ABSTRACT: Psychological intimate partner violence, reported by one in five mothers in this study, on average doubles the avoidance of breastfeeding.


Assuntos
Aleitamento Materno , Violência por Parceiro Íntimo , Adulto , Aleitamento Materno/psicologia , Aleitamento Materno/estatística & dados numéricos , Estudos de Coortes , Correlação de Dados , Demografia , Feminino , Humanos , Violência por Parceiro Íntimo/prevenção & controle , Violência por Parceiro Íntimo/psicologia , Violência por Parceiro Íntimo/estatística & dados numéricos , Masculino , Período Pós-Parto/psicologia , Gravidez , Resultado da Gravidez/epidemiologia , Resultado da Gravidez/psicologia , Cuidado Pré-Natal/métodos , Cuidado Pré-Natal/estatística & dados numéricos , Trauma Psicológico , Medição de Risco , Fatores Socioeconômicos , Espanha/epidemiologia
6.
BJOG ; 125(7): 795-803, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29030992

RESUMO

BACKGROUND: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. OBJECTIVE: To assess safety reporting in pre-eclampsia trials. SEARCH STRATEGY: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. SELECTION CRITERIA: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. DATA COLLECTION AND ANALYSIS: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. MAIN RESULTS: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. CONCLUSIONS: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. FUNDING: National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. TWEETABLE ABSTRACT: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.


Assuntos
Anticonvulsivantes/efeitos adversos , Anti-Hipertensivos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Segurança do Paciente/estatística & dados numéricos , Pré-Eclâmpsia/tratamento farmacológico , Projetos de Pesquisa/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
BJOG ; 125(1): 16-25, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29024294

RESUMO

BACKGROUND: Preterm birth may leave the brain vulnerable to dysfunction. Knowledge of future neurodevelopmental delay in children born with various degrees of prematurity is needed to inform practice and policy. OBJECTIVE: To quantify the long-term cognitive, motor, behavioural and academic performance of children born with different degrees of prematurity compared with term-born children. SEARCH STRATEGY: PubMed and Embase were searched from January 1980 to December 2016 without language restrictions. SELECTION CRITERIA: Observational studies that reported neurodevelopmental outcomes from 2 years of age in children born preterm compared with a term-born cohort. DATA COLLECTION AND ANALYSIS: We pooled individual estimates of standardised mean differences (SMD) and odds ratios (OR) with 95% confidence intervals using a random effects model. MAIN RESULTS: We included 74 studies (64 061 children). Preterm children had lower cognitive scores for FSIQ (SMD: -0.70; 95% CI: -0.73 to -0.66), PIQ (SMD: -0.67; 95% CI: -0.73 to -0.60) and VIQ (SMD: -0.53; 95% CI: -0.60 to -0.47). Lower scores for preterm children in motor skills, behaviour, reading, mathematics and spelling were observed at primary school age, and this persisted to secondary school age, except for mathematics. Gestational age at birth accounted for 38-48% of the observed IQ variance. ADHD was diagnosed twice as often in preterm children (OR: 1.6; 95% CI: 1.3-1.8), with a differential effect observed according to the severity of prematurity (I2 = 49.4%, P = 0.03). CONCLUSIONS: Prematurity of any degree affects the cognitive performance of children born preterm. The poor neurodevelopment persists at various ages of follow up. Parents, educators, healthcare professionals and policy makers need to take into account the additional academic, emotional and behavioural needs of these children. TWEETABLE ABSTRACT: Adverse effect of preterm birth on a child's neurodevelopment persists up to adulthood.


Assuntos
Transtornos do Comportamento Infantil/etiologia , Transtornos Cognitivos/etiologia , Deficiências do Desenvolvimento/etiologia , Recém-Nascido Prematuro/fisiologia , Transtornos Psicomotores/etiologia , Sucesso Acadêmico , Criança , Pré-Escolar , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Transtornos das Habilidades Motoras/etiologia , Estudos Observacionais como Assunto
8.
BJOG ; 124(7): 1057-1061, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28322491

RESUMO

OBJECTIVE: Prospective registration of clinical trials has been required since 2005. We aimed to assess concordance between registered and reported sample sizes among prospectively registered randomised controlled trials (RCTs) in obstetrics and gynaecology. DESIGN: Analysis of prospectively registered and published data. SETTING: Women's health. SAMPLE: Obstetrics and gynaecology RCTs published in eight journals in 2015. METHODS: Specialist (Acta Obstet Gynecol Scand, BJOG, Obstet Gynecol and Am J Obstet Gynecol) and general (BMJ, N Engl J Med, JAMA and Lancet) journals were searched from 1 January to 31 December 2015 for main reports of obstetrics and gynaecology RCTs. Their corresponding registries and protocols were sought and data were extracted. Proportions and 95% CI were calculated using exact methods. MAIN OUTCOME MEASURES: Prospective registration of RCT and sample size concordance between RCTs and their registries within those where registration took place before patients were recruited. RESULTS: Of the 75 relevant RCTs, 51 (68%, 95% CI 56-78%, P < 0.001 using a null hypothesis requiring 100% compliance) were prospectively registered, a feature found to be more common in general journals versus specialist journals (21/22 versus 30/53, 95% versus 57%, P = 0.001). Of the 51 prospectively registered RCTs, 31 (61%, 95% CI 46-74%, P = 0.003 using a null hypothesis requiring 40% of studies to achieve their stated sample size) did not reach the target sample size. CONCLUSIONS: There are gaps in universal adoption of the prospective trial registration rule. Inability to meet target sample size risks deficiencies in statistical power with unreliability in results. TWEETABLE ABSTRACT: Only two-thirds of RCTs in women's health are prospectively registered, and over half fail to achieve target sample sizes.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Tamanho da Amostra , Saúde da Mulher/estatística & dados numéricos , Ginecologia/estatística & dados numéricos , Humanos , Obstetrícia/estatística & dados numéricos , Estudos Prospectivos , Sistema de Registros/estatística & dados numéricos , Reprodutibilidade dos Testes , Risco , Inquéritos e Questionários
9.
BJOG ; 124(5): 734-741, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28029229

RESUMO

BACKGROUND: Syphilis in pregnancy can lead to fetal and neonatal death or congenital anomalies. Accurate on-site tests are an essential part of effective prevention of mother-to-child transmission of the disease. OBJECTIVE: This systematic review assessed the accuracy of on-site tests to detect infection with Treponema pallidum in pregnant women. SEARCH STRATEGY: Major databases were searched from inception to January 2016 using terms: 'pregnancy', 'antenatal', 'syphilis', 'Treponema pallidum' with their variations, and the search limit for the relevant study design. SELECTION CRITERIA: We included studies that used dual reference standard (non-treponemal and treponemal tests) to detected syphilis in pregnancy. DATA COLLECTION AND ANALYSIS: Extracted accuracy data were tabulated and pooled using hierarchical, bivariate random effects model. MAIN RESULTS: Seven studies (combined sample 17 546) reporting the accuracy of four on-site tests met the eligibility criteria. On average, Determine™ and SD BioLine Syphilis 3.0 had the highest sensitivity of all the evaluated tests: 0.83 (95% CI 0.58, 0.98) and 0.86 (95% CI 0.82, 0.89), respectively, with a high specificity 0.96 (95% CI 0.89, 1.00) and 0.99 (95% CI 0.94, 1.00), respectively. The Qualitative Rapid Plasma Reagin card commonly used in clinical practice had a pooled sensitivity of 0.70 (95% CI 0.54, 0.88) and specificity of 0.97 (95% CI 0.96, 0.99). CONCLUSION: Immunochromatographic tests such as Determine™ and SD BioLine Syphilis 3.0 seem to be acceptable options in antenatal testing for syphilis, especially in resource-limited settings. Future research should seek more evidence to strengthen this claim. TWEETABLE ABSTRACT: On-site test to detect syphilis-options during antenatal care.


Assuntos
Sistemas Automatizados de Assistência Junto ao Leito , Complicações Infecciosas na Gravidez/diagnóstico , Sorodiagnóstico da Sífilis/métodos , Sífilis/diagnóstico , Feminino , Humanos , Gravidez , Cuidado Pré-Natal/métodos , Sensibilidade e Especificidade , Treponema pallidum
10.
BJOG ; 124(5): 727-733, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27862893

RESUMO

BACKGROUND: There is a dearth of data on the clinical features and outcomes of active tuberculosis (TB) in pregnancy. Studies have shown varied results and the relationship between TB and adverse pregnancy outcomes remains unclear. OBJECTIVES: We conducted a systematic review and meta-analysis to evaluate pregnancy outcomes associated with TB. SEARCH STRATEGY: Major databases were searched from inception until December 2015 without restrictions using the terms: 'TB', 'pregnancy', 'maternal morbidity', 'mortality' and 'perinatal morbidity', 'mortality'. SELECTION CRITERIA: We included studies that compared the outcomes of pregnant women with and without active TB. DATA COLLECTION AND ANALYSIS: We computed odds ratios for maternal and perinatal complications, and pooled them using a random effects model. We assessed for heterogeneity using chi-squared tests and evaluated its magnitude using the I2 statistic. We used the Newcastle-Ottawa scale for quality assessment. MAIN RESULTS: Thirteen studies, including 3384 pregnancies with active TB and 119 448 without TB were included. Compared with pregnant women without TB, pregnant women with active TB was associated with increased odds of maternal morbidity [odds ratio (OR) 2.8, 95% CI 1.7-4.6; I2  = 60.3%], anaemia (OR 3.9, 95% CI 2.2-6.7; I2  = 29.8%), caesarean delivery (OR 2.1, 95% CI 1.2-3.8; I2  = 61.1%), preterm birth (OR 1.7, 95% CI 1.2-2.4; I2  = 66.5%), low birth weight (OR 1.7, 95% CI 1.2-2.4; I2  = 53.7%), birth asphyxia (OR 4.6, 95% CI 2.4-8.6; I2  = 46.3), and perinatal death (OR 4.2, 95% CI 1.5-11.8; I2  = 57.2%). AUTHOR'S CONCLUSION: Active TB in pregnancy is associated with adverse maternal and fetal outcomes. Early diagnosis of TB is important to prevent significant maternal and perinatal complications. TWEETABLE ABSTRACT: Active tuberculosis in pregnancy is associated with adverse maternal and perinatal outcomes.


Assuntos
Mortalidade Materna , Mortalidade Perinatal , Complicações Infecciosas na Gravidez/mortalidade , Resultado da Gravidez/epidemiologia , Tuberculose/mortalidade , Feminino , Humanos , Recém-Nascido , Período Pós-Parto , Gravidez
11.
BJOG ; 124(6): 863-871, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28194870

RESUMO

BACKGROUND: Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients. OBJECTIVES: To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health. SEARCH STRATEGY: Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015. SELECTION CRITERIA: We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort. DATA COLLECTION AND ANALYSIS: Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression. MAIN RESULTS: There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with non-participants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I2  = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88). CONCLUSIONS: Women participating in RCTs on average experienced better outcomes compared with those outside trials. TWEETABLE ABSTRACT: Participants in obstetric and gynaecology RCTs experience better outcomes compared with non-participants.


Assuntos
Avaliação de Resultados da Assistência ao Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Sujeitos da Pesquisa/estatística & dados numéricos , Saúde da Mulher/estatística & dados numéricos , Feminino , Humanos
12.
BJOG ; 124(10): 1481-1489, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28421657

RESUMO

BACKGROUND: Variation in outcome collection and reporting is a serious hindrance to progress in our specialty; therefore, over 80 journals have come together to support the development, dissemination, and implementation of core outcome sets. OBJECTIVE: This study systematically reviewed and characterised registered, progressing, or completed core outcome sets relevant to women's and newborn health. SEARCH STRATEGY: Systematic search using the Core Outcome Measures in Effectiveness Trial initiative and the Core Outcomes in Women's and Newborn Health initiative databases. SELECTION CRITERIA: Registry entries, protocols, systematic reviews, and core outcome sets. DATA COLLECTION AND ANALYSIS: Descriptive statistics to describe characteristics and results. RESULTS: There were 49 core outcome sets registered in maternal and newborn health, with the majority registered in 2015 (n = 22; 48%) or 2016 (n = 16; 32%). Benign gynaecology (n = 8; 16%) and newborn health (n = 3; 6%) are currently under-represented. Twenty-four (52%) core outcome sets were funded by international (n = 1; <1%), national (n = 18; 38%), and regional (n = 4; 8%) bodies. Seven protocols were published. Twenty systematic reviews have characterised the inconsistency in outcome reporting across a broad range of relevant healthcare conditions. Four core outcome sets were completed: reconstructive breast surgery (11 outcomes), preterm birth (13 outcomes), epilepsy in pregnancy (29 outcomes), and maternity care (48 outcomes). The quantitative, qualitative, and consensus methods used to develop core outcome sets varied considerably. CONCLUSIONS: Core outcome sets are currently being developed across women's and newborn health, although coverage of topics is variable. Development of further infrastructure to develop, disseminate, and implement core outcome sets is urgently required. TWEETABLE ABSTRACT: Forty-nine women's and newborn core outcome sets registered. 50% funded. 7 protocols, 20 systematic reviews, and 4 core outcome sets published. @coreoutcomes @jamesmnduffy.


Assuntos
Saúde do Lactente/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde , Saúde da Mulher/estatística & dados numéricos , Adolescente , Adulto , Feminino , Ginecologia , Humanos , Recém-Nascido , Serviços de Saúde Materno-Infantil/estatística & dados numéricos , Obstetrícia , Gravidez , Projetos de Pesquisa , Adulto Jovem
13.
BJOG ; 124(12): 1829-1839, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28432737

RESUMO

BACKGROUND: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. OBJECTIVES: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases from inception to January 2016. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: We systematically extracted and categorised outcome reporting. MAIN RESULTS: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. CONCLUSIONS: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. TWEETABLE ABSTRACT: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.


Assuntos
Pré-Eclâmpsia/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , Humanos , Recém-Nascido , Mortalidade Materna , Mortalidade Perinatal , Pré-Eclâmpsia/mortalidade , Gravidez , Resultado do Tratamento
14.
BJOG ; 124(4): 661-667, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-27860117

RESUMO

OBJECTIVE: To develop a set of core outcomes for studies on pregnant women with epilepsy. DESIGN: Delphi consensus study. POPULATION: Healthcare professionals, and patient representatives with lived experience of epilepsy in the UK. METHODS: We used a modified Delphi method and a consultation meeting to achieve consensus. Potential outcomes were identified by systematic review, and were scored using a Likert scale anchored between 1 (least important) and 5 (most important). We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants. MAIN OUTCOME MEASURES: Outcomes in studies on epilepsy in pregnancy. RESULTS: Seventy-five healthcare professionals completed the first round, 48 (64%) completed the second round, and 37 (49%) completed the third round of the survey. Twenty-four patient representatives participated. The final core outcome set included 31 outcomes in three domains: neurological, offspring, and obstetric. Outcomes in the neurological domain were seizure control in pregnancy and postpartum, status epilepticus, maternal mortality, drowning, sudden unexpected death in epilepsy, postnatal depression, and quality of life. Offspring domain included congenital abnormalities (major and minor), fetal anticonvulsant syndrome, neurodevelopment, autism disorder, neonatal clinical complications, admission to a neonatal intensive care unit, and anthropometric measurements. The obstetric domain included live birth, stillbirth, miscarriage, ectopic, termination of pregnancy, admission to a high dependency or intensive care unit, breastfeeding, mode of delivery, preterm birth, pre-eclampsia, and eclampsia. Outcomes specific for studies on anti-epileptic drugs (AEDs) included maternal AED toxicity, AED compliance, neonatal withdrawal symptoms, and neonatal haemorrhagic disease. CONCLUSION: Embedding this core set in future clinical trials will promote the standardisation of reporting to inform clinical practice. TWEETABLE ABSTRACT: A Delphi method identifying core outcomes for epilepsy in pregnancy. Final core set includes 31 outcomes.


Assuntos
Epilepsia/complicações , Complicações na Gravidez/epidemiologia , Resultado da Gravidez/epidemiologia , Consenso , Técnica Delphi , Determinação de Ponto Final , Feminino , Humanos , Mortalidade Materna , Gravidez , Complicações na Gravidez/etiologia , Estudos Prospectivos , Qualidade de Vida , Projetos de Pesquisa , Inquéritos e Questionários , Reino Unido , Adulto Jovem
15.
Transfus Med ; 27(3): 167-174, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28425182

RESUMO

The aim of this review was to understand the landscape of serum ferritin in diagnosing iron deficiency in the aetiology of anaemia in pregnancy. Iron deficiency in pregnancy is a major public health problem leading to the development of anaemia. Reducing the global prevalence of anaemia in women of reproductive age is a 2025 global nutrition target. Bone marrow aspiration is the gold standard test for iron deficiency but requires an invasive procedure; therefore, serum ferritin is the most clinically useful test. We undertook a systematic search of electronic databases and trial registers from inception to January 2016. Studies of iron or micronutrient supplementation in pregnancy with pre-defined serum ferritin thresholds were included. Two independent reviewers selected studies, extracted data and assessed quality. There were 76 relevant studies mainly of observational study design (57%). The most commonly used thresholds of serum ferritin for the diagnosis of iron deficiency were <12 and <15 ng mL-1 (68%). Most primary studies provided no justification for the choice of serum ferritin threshold used, but 25 studies (33%) used thresholds defined by expert consensus in a guideline development process. There were five studies (7%) using a serum ferritin threshold defining iron deficiency derived from primary studies of bone marrow aspiration. Unified international thresholds of iron deficiency for women throughout pregnancy are required for accurate assessments of the global disease burden and for evaluating effectiveness of interventions addressing this problem.


Assuntos
Anemia Ferropriva , Ferritinas/sangue , Ferro , Complicações Hematológicas na Gravidez , Anemia Ferropriva/sangue , Anemia Ferropriva/diagnóstico , Feminino , Humanos , Ferro/sangue , Deficiências de Ferro , Gravidez , Complicações Hematológicas na Gravidez/sangue , Complicações Hematológicas na Gravidez/diagnóstico
16.
BJOG ; 123(11): 1761-8, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27173590

RESUMO

BACKGROUND: The development of a non-invasive and accurate diagnostic biomarker for endometriosis is urgently needed. OBJECTIVE: Evaluate the diagnostic accuracy of serum cancer antigen 125 (CA 125) for endometriosis. SEARCH STRATEGY: We searched EMBASE, MEDLINE, and Web of Science from inception to January 2016. SELECTION CRITERIA: Diagnostic accuracy studies of serum CA 125 (index test) for histologically confirmed endometriosis (reference standard) were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, extracted study characteristics and data. Methodological quality was assessed using Quality Assessment of Comparative Diagnostic Accuracy Studies (QUADAS-2) checklist. MAIN RESULTS: Twenty-two studies (16 cohort, six case-control), 3626 participants, were identified. Bivariate hierarchical models were used to pool accuracy data of 14 studies (2920 participants) using CA 125 ≥ 30 units/ml. Pooled specificity was 93% (95% CI 89-95%) and sensitivity 52% (95% CI 38-66%). CA 125 was significantly more sensitive for the diagnosis of moderate or severe endometriosis compared with minimal disease (63%, 95% CI 47-77% versus 24%, 95%CI 19-32%, P-value = 0.001). CONCLUSIONS: CA 125 performs well as a rule-in test facilitating expedited diagnosis and ensuring investigation and treatment can be confidently tailored for the management of endometriosis. Unfortunately, a negative test, CA 125 < 30 units/ml, is unable to rule out endometriosis. TWEETABLE ABSTRACT: Blood test CA 125: a rule-in test for the diagnosis of women presenting with symptoms of endometriosis.


Assuntos
Antígeno Ca-125/sangue , Endometriose/diagnóstico , Proteínas de Membrana/sangue , Adulto , Biomarcadores/sangue , Feminino , Humanos , Valor Preditivo dos Testes , Sensibilidade e Especificidade
17.
BJOG ; 123(5): 730-7, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26399217

RESUMO

OBJECTIVE: To determine the relationship of interpregnancy interval with maternal and offspring outcomes. DESIGN: Retrospective study with data from the Perinatal Information System database of the Latin American Centre for Perinatology and Human Development, Uruguay. SETTING: Latin America, 1990-2009. POPULATION: A cohort of 894 476 women delivering singleton infants. METHODS: During 1990-2009 the Perinatal Information System database of the Latin American Centre for Perinatology identified 894 476 women with defined interpregnancy intervals: i.e. the time elapsed between the date of the previous delivery and the first day of the last normal menstrual period for the index pregnancy. Using the interval 12-23 months as the reference category, multiple logistic regression estimated adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) of the association between various interval lengths and maternal and offspring outcomes. MAIN OUTCOME MEASURES: Maternal death, pre-eclampsia, eclampsia, puerperal infection, fetal death, neonatal death, preterm birth, and low birthweight. RESULTS: In the reference interval there was 0.05% maternal death, 1.00% postpartum haemorrhage, 2.80% pre-eclampsia, 0.15% eclampsia, 0.28% puerperal infection, 3.45% fetal death, 0.68% neonatal death, 12.33% preterm birth, and 9.73% low birthweight. Longer intervals had increased odds of pre-eclampsia (>72 months), fetal death (>108-119 months), and low birthweight (96-107 months). Short intervals of <12 months had increased odds of pre-eclampsia (aOR 0.80; 95% CI 0.76-0.85), neonatal death (aOR 1.18; 95% CI 1.08-1.28), and preterm birth (aOR 1.16; 95% CI 1.11-1.21). Statistically, the interval had no relationship with maternal death, eclampsia, and puerperal infection. CONCLUSIONS: A short interpregnancy interval of <12 months is associated with pre-eclampsia, neonatal mortality, and preterm birth, but not with other maternal or offspring outcomes. Longer intervals of >72 months are associated with pre-eclampsia, fetal death, and low birthweight, but not with other maternal or offspring outcomes. TWEETABLE ABSTRACT: A short interpregnancy interval of <12 months is associated with neonatal mortality and preterm birth.


Assuntos
Intervalo entre Nascimentos , Mortalidade Infantil , Recém-Nascido de Baixo Peso , Complicações na Gravidez/etiologia , Feminino , Humanos , Lactente , Recém-Nascido , América Latina/epidemiologia , Modelos Logísticos , Estudos Longitudinais , Razão de Chances , Paridade , Gravidez , Complicações na Gravidez/epidemiologia , Resultado da Gravidez , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo
18.
BJOG ; 123(6): 1005-10, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26776314

RESUMO

OBJECTIVE: To evaluate, among medical students learning the female pelvic examination, the added benefits of training by gynaecological teaching associates compared with training involving a manikin only. DESIGN: Randomised controlled trial. SETTING: Nine university teaching hospitals. POPULATION: Ninety-four medical students recruited prior to commencing a 4-week obstetrics and gynaecology rotation. METHODS: The control training consisted of lectures, demonstration of the pelvic examination on a manikin, and opportunities to practise on this low-fidelity simulation (n = 40). The experimental group received additional gynaecological teaching associate training, delivered by pairs of experienced associates to groups of four medical students (n = 54). MAIN OUTCOME MEASURES: Outcomes measured at the end of the rotation included knowledge of the correct order of examination components (Yes/No), and student comfort [Likert scales anchored between 1 (very uncomfortable) and 4 (very comfortable) on four items] and confidence [Likert scales anchored between 1 (No) and 3 (Yes) on six items]. The primary outcome, measured at the end of the academic year, was the objective structured clinical examination of a female pelvis (score range 0-54). RESULTS: At baseline, the groups were similar in age, gender, and ethnicity. At the end of the clinical rotation, when compared with the control intervention, the experimental intervention had a moderate effect on student knowledge [difference 29.9% (95% CI 11.2-48.6%); P = 0.002] and confidence [difference 1 (95% CI 0-2); P < 0.001], and a large effect on student comfort [difference 1.8 (95% CI 0.6-3.0); P = 0.004]. At the end of the academic year, the experimental intervention had no impact on skills compared with the control [difference 2 (95% CI-1 to 4); P = 0.26]. CONCLUSIONS: Among medical students taught the female pelvic examination by low-fidelity simulation, additional training by gynaecology teaching associates improved knowledge, comfort, and confidence at the end of the clinical rotation but did not improve examination skills at end of the academic year.


Assuntos
Competência Clínica , Educação de Graduação em Medicina/métodos , Exame Ginecológico , Ginecologia/educação , Ensino/métodos , Adulto , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Manequins , Autoeficácia , Adulto Jovem
19.
BJOG ; 123(2): 190-8, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26841002

RESUMO

OBJECTIVE: To develop maternal, fetal, and neonatal composite outcomes relevant to the evaluation of diet and lifestyle interventions in pregnancy by individual patient data (IPD) meta-analysis. DESIGN: Delphi survey. SETTING: The International Weight Management in Pregnancy (i-WIP) collaborative network. Sample Twenty-six researchers from the i-WIP collaborative network from 11 countries. METHODS: A two-generational Delphi survey involving members of the i-WIP collaborative network (26 members in 11 countries) was undertaken to prioritise the individual outcomes for their importance in clinical care. The final components of the composite outcomes were identified using pre-specified criteria. MAIN OUTCOME MEASURES: Composite outcomes considered to be important for the evaluation of the effect of diet and lifestyle in pregnancy. RESULTS: Of the 36 maternal outcomes, nine were prioritised and the following were included in the final composite: pre-eclampsia or pregnancy-induced hypertension, gestational diabetes mellitus (GDM), elective or emergency caesarean section, and preterm delivery. Of the 27 fetal and neonatal outcomes, nine were further evaluated, with the final composite consisting of intrauterine death, small for gestational age, large for gestational age, and admission to a neonatal intensive care unit (NICU). CONCLUSIONS: Our work has identified the components of maternal, fetal, and neonatal composite outcomes required for the assessment of diet and lifestyle interventions in pregnancy by IPD meta-analysis.


Assuntos
Cesárea/estatística & dados numéricos , Diabetes Gestacional/epidemiologia , Obesidade/prevenção & controle , Pré-Eclâmpsia/epidemiologia , Complicações na Gravidez/prevenção & controle , Gestantes , Nascimento Prematuro/etiologia , Adulto , Técnica Delphi , Diabetes Gestacional/etiologia , Dieta Redutora , Feminino , Humanos , Recém-Nascido , Estilo de Vida , Obesidade/complicações , Pré-Eclâmpsia/etiologia , Gravidez , Complicações na Gravidez/etiologia , Resultado da Gravidez , Nascimento Prematuro/epidemiologia , Aumento de Peso
20.
Ultrasound Obstet Gynecol ; 47(1): 22-7, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26031231

RESUMO

OBJECTIVE: To assess the predictive accuracy for stillbirth of second-trimester uterine artery Doppler. METHODS: We searched MEDLINE, EMBASE and The Cochrane Library databases from inception until March 2015 without language restrictions. The included studies were those that assessed the association of abnormal uterine artery Doppler parameters and stillbirth. Two independent reviewers selected the studies, extracted data and assessed quality. Results for studies that were performed in the second trimester were pooled and summary estimates of sensitivity, specificity, likelihood ratios and their 95% confidence intervals were obtained. An overall summary of test accuracy was provided by the diagnostic odds ratio. Subgroup analysis was performed according to whether the study population was high risk or unselected. RESULTS: Literature searches returned 338 relevant citations with 32 considered in full. Thirteen studies met our search criteria (85 845 women, 508 stillbirths) and were included in the review. Bivariate pooled estimate for sensitivity was 65% (95% CI, 38-85%) and for specificity 82% (95% CI, 72-88%). The positive likelihood ratio was 3.5 (95% CI, 2.3-5.5) and negative likelihood ratio 0.43 (95% CI, 0.22-0.85). The diagnostic odds ratio was 8.3 (95% CI, 3.0-22.4). Heterogeneity was high in the studies of high-risk women. CONCLUSIONS: Abnormal uterine artery Doppler indices are associated with a three- to four-fold increase in the risk of stillbirth. The heterogeneity was particularly high in the high-risk group rendering it impossible to draw firm conclusions. In view of this, there is a role for individual patient data meta-analysis to define which Doppler parameter and threshold value should be measured.


Assuntos
Natimorto/epidemiologia , Artéria Uterina/diagnóstico por imagem , Feminino , Humanos , Funções Verossimilhança , Valor Preditivo dos Testes , Gravidez , Segundo Trimestre da Gravidez , Medição de Risco , Ultrassonografia Doppler , Ultrassonografia Pré-Natal
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