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1.
Eur J Obstet Gynecol Reprod Biol ; 268: 62-67, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34871953

RESUMO

OBJECTIVES: To assess the feasibility of external cephalic version (ECV) for the leading twin (twin A) in breech presentation in dichorionic and diamniotic twin pregnancies without the use of regional anesthetics and tocolysis and to characterize the sonographic parameters, maternal and neonatal outcomes. STUDY DESIGN: Prospective study performed in the Charité University Hospital outpatient obstetric department in Berlin, Germany. A total of 23 women from the 35th completed week of pregnancy with confirmed dichorionic-diamniotic twin pregnancy were recruited. ECVs were performed by the lead consultant for the breech and ECV clinic. Ethical approval provided by the Charité Ethics Commission (EA2/241/18). Demographic data were recorded. Fetal sonographic parameters were assessed. The success rate of ECV, duration of the ECV, gestational age at delivery, mode of delivery for both fetuses, maternal and neonatal outcomes were analyzed. RESULTS: Our main finding showed that ECV for twin A breech in dichorionic-diamniotic twins is successful in 56% (10/18) of cases without the need for regional anesthesia and without tocolysis. There is a significant increase in the spontaneous vaginal delivery rate for both twins of 95% (19/20) vs 12.5% (2/16) (p < 0.001). There is also a significant reduction in blood loss at delivery of 300 ml vs 500 ml (p = 0.034) in successful cases. CONCLUSIONS: We show that ECV for twin A in breech is feasible and in 56% (10/18) successful without regional anesthesia and tocolysis. The option of ECV for twin A breech should be offered to women.


Assuntos
Anestesia por Condução , Apresentação Pélvica , Versão Fetal , Apresentação Pélvica/diagnóstico por imagem , Apresentação Pélvica/terapia , Estudos de Viabilidade , Feminino , Humanos , Recém-Nascido , Gravidez , Estudos Prospectivos , Tocólise
2.
J Obstet Gynaecol Can ; 38(3): 235-245.e3, 2016 03.
Artigo em Inglês | MEDLINE | ID: mdl-27106193

RESUMO

OBJECTIVE: According to the Early External Cephalic Version (EECV2) Trial, planning external cephalic version (ECV) early in pregnancy results in fewer breech presentations at delivery compared with delayed external cephalic version. A Cochrane review conducted after the EECV2 Trial identified an increase in preterm birth associated with early ECV. We examined whether a policy of routine early ECV (i.e., before 37 weeks' gestation) is more or less costly than a policy of delayed ECV. METHODS: We undertook this analysis from the perspective of a third-party payer (Ministry of Health). We applied data, using resources reported in the EECV2 Trial, to the Canadian context using 10 hospital unit costs and 17 physician service/procedure unit costs. The data were derived from the provincial health insurance plan schedule of medical benefits in three Canadian provinces (Ontario, Alberta, and British Columbia). The difference in mean total costs between study groups was tested for each province separately. RESULTS: We found that planning early ECV results in higher costs than planning delayed ECV. The mean costs of all physician services/procedures and hospital units for planned ECV compared with delayed ECV were $7997.32 versus $7263.04 in Ontario (P < 0.001), $8162.82 versus $7410.55 in Alberta (P < 0.001), and $8178.92 versus $7417.04 in British Columbia (P < 0.001), respectively. CONCLUSION: From the perspective of overall cost, our analyses do not support a policy of routinely planning ECV before 37 weeks' gestation.


Assuntos
Apresentação Pélvica , Parto Obstétrico , Nascimento Prematuro , Versão Fetal/estatística & dados numéricos , Apresentação Pélvica/economia , Apresentação Pélvica/epidemiologia , Apresentação Pélvica/terapia , Canadá/epidemiologia , Análise Custo-Benefício , Parto Obstétrico/economia , Parto Obstétrico/estatística & dados numéricos , Feminino , Humanos , Gravidez , Nascimento Prematuro/economia , Nascimento Prematuro/epidemiologia , Fatores de Tempo
3.
J Obstet Gynaecol Res ; 41(7): 1023-31, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25771920

RESUMO

AIM: Neuraxial blockade (epidural or spinal anesthesia/analgesia) with external cephalic version increases the external cephalic version success rate. Hospitals and insurers may affect access to neuraxial blockade for external cephalic version, but the costs to these institutions remain largely unstudied. The objective of this study was to perform a cost analysis of neuraxial blockade use during external cephalic version from hospital and insurance payer perspectives. Secondarily, we estimated the effect of neuraxial blockade on cesarean delivery rates. METHODS: A decision-analysis model was developed using costs and probabilities occurring prenatally through the delivery hospital admission. Model inputs were derived from the literature, national databases, and local supply costs. Univariate and bivariate sensitivity analyses and Monte Carlo simulations were performed to assess model robustness. RESULTS: Neuraxial blockade was cost saving to both hospitals ($30 per delivery) and insurers ($539 per delivery) using baseline estimates. From both perspectives, however, the model was sensitive to multiple variables. Monte Carlo simulation indicated neuraxial blockade to be more costly in approximately 50% of scenarios. The model demonstrated that routine use of neuraxial blockade during external cephalic version, compared to no neuraxial blockade, prevented 17 cesarean deliveries for every 100 external cephalic versions attempted. CONCLUSIONS: Neuraxial blockade is associated with minimal hospital and insurer cost changes in the setting of external cephalic version, while reducing the cesarean delivery rate.


Assuntos
Analgesia Obstétrica/efeitos adversos , Apresentação Pélvica/cirurgia , Sistemas de Apoio a Decisões Clínicas , Bloqueio Nervoso/efeitos adversos , Versão Fetal/efeitos adversos , Adulto , Analgesia Epidural/efeitos adversos , Analgesia Epidural/economia , Analgesia Obstétrica/economia , Anestesia Epidural/efeitos adversos , Anestesia Epidural/economia , Anestesia Obstétrica/efeitos adversos , Anestesia Obstétrica/economia , Raquianestesia/efeitos adversos , Raquianestesia/economia , Apresentação Pélvica/economia , Cesárea/efeitos adversos , Cesárea/economia , Redução de Custos , Custos e Análise de Custo , Árvores de Decisões , Feminino , Custos Hospitalares , Humanos , Reembolso de Seguro de Saúde , Bloqueio Nervoso/economia , Gravidez , Estados Unidos , Versão Fetal/economia
4.
Acupunct Med ; 33(2): 136-41, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25669428

RESUMO

AIMS: To analyse the cost effectiveness of using the moxibustion technique to correct non-vertex presentation and to reduce the number of caesarean sections performed at term. METHOD: A deterministic model of decision analysis has been developed to analyse the cost of treatment in which heat is applied by moxibustion (the combustion of Artemisia vulgaris) at acupuncture point BL67 for pregnant women with non-vertex fetal position at 33-35 weeks' gestation. This approach was compared with conventional treatment recommendations based on the knee-chest posture technique. The costs were obtained mainly from data provided by the Andalusian Public Health System. Effectiveness data for the baseline analysis were taken from a previous clinical study. A secondary analysis was performed based on a meta-analysis conducted using random effects analysis, by reference to studies published in recent systematic reviews of moxibustion versus conventional treatment, in order to make the results generalisable to other healthcare settings. Deterministic and probabilistic sensitivity analyses were performed under diverse assumptions to assess the uncertainty of the result. RESULTS: The baseline analysis shows that the application of moxibustion prevents 8.92% of deliveries with non-vertex presentation compared with conventional treatment, with an average cost saving of €107.11 per delivery, mainly due to the cost saving from avoiding the need for caesarean section. The meta-analysis revealed a relative risk of the version of non-vertex presentation at term of 0.34 (95% CI 0.16 to 0.76). The sensitivity analysis showed that moxibustion can avoid 0.34 caesarean sections, with an incremental cost per delivery ranging from €68 to -€640 for moxibustion versus conventional treatment. CONCLUSIONS: Moxibustion treatment applied at acupuncture point BL67 can avoid the need for caesarean section and achieve cost savings for the healthcare system in comparison with conventional treatment.


Assuntos
Apresentação Pélvica/economia , Apresentação Pélvica/terapia , Moxibustão/economia , Pontos de Acupuntura , Adulto , Artemisia/química , Análise Custo-Benefício , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Versão Fetal/economia
5.
J Matern Fetal Neonatal Med ; 28(1): 49-54, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24593778

RESUMO

OBJECTIVE: To identify predictors of successful external cephalic version (ECV) and to compare delivery outcome between women who had a successful ECV and women with spontaneous vertex presentation. METHODS: A retrospective cohort study of all women who underwent ECV in a single tertiary medical center between 2007 and 2011. Delivery outcome was compared between women who underwent a trial of vaginal delivery following successful ECV with that of a control group in a 2:1 ratio. Multivariate analysis was used to identify predictors of successful ECV. RESULTS: Overall 287 were eligible for the study group. Of these 130 (45.3%) had a successful ECV. Polyhydramnios was the strongest factor associated with successful ECV (OR=3.1, 95%-CI 1.4-7.2), followed by transverse lie (versus breech presentation, OR=2.6, 95%-CI 1.2-6.7) and a posterior placenta (OR=1.7, 95%-CI 1.1-3.9), while nulliparity was associated with a lower likelihood of successful ECV (OR=0.4, 95%-CI 0.2-0.6). Women who had a successful ECV and underwent a trial of labor were more likely to deliver by operative vaginal delivery (OVD) (OR=1.8, 95%-CI 1.2-3.6), mainly due to a higher rate of prolonged 2nd, but were not at an increased risk for CS (OR=0.9, 95%-CI 0.4-2.4). CONCLUSIONS: Counselling to women prior to ECV should address the likelihood of success based on the predicting factors described above, as well as the increased risk for OVD in the case of successful ECV.


Assuntos
Apresentação Pélvica/terapia , Versão Fetal/estatística & dados numéricos , Adulto , Feminino , Humanos , Gravidez , Estudos Retrospectivos
6.
Clin Perinatol ; 40(3): 399-412, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23972747

RESUMO

Breech presentation is common at term and its reduction through external cephalic version represents a noninvasive opportunity to avoid cesarean delivery and the associated maternal morbidity. In addition to uterine relaxants, neuraxial anesthesia is associated with increased success of version procedures when surgical anesthetic dosing is used. The intervention is likely cost effective given the effect size and the avoided high costs of cesarean delivery.


Assuntos
Analgesia Epidural/métodos , Analgesia Obstétrica/métodos , Apresentação Pélvica/terapia , Versão Fetal/métodos , Analgesia Epidural/economia , Analgesia Obstétrica/economia , Cesárea/economia , Feminino , Humanos , Satisfação do Paciente , Gravidez , Resultado do Tratamento , Versão Fetal/economia
7.
Anesth Analg ; 117(1): 155-9, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23592608

RESUMO

BACKGROUND: In this study, we sought to determine whether neuraxial anesthesia to facilitate external cephalic version (ECV) increased delivery costs for breech fetal presentation. METHODS: Using a computer cost model, which considers possible outcomes and probability uncertainties at the same time, we estimated total expected delivery costs for breech presentation managed by a trial of ECV with and without neuraxial anesthesia. RESULTS: From published studies, the average probability of successful ECV with neuraxial anesthesia was 60% (with individual studies ranging from 44% to 87%) compared with 38% (with individual studies ranging from 31% to 58%) without neuraxial anesthesia. The mean expected total delivery costs, including the cost of attempting/performing ECV with anesthesia, equaled $8931 (2.5th-97.5th percentile prediction interval $8541-$9252). The cost was $9207 (2.5th-97.5th percentile prediction interval $8896-$9419) if ECV was attempted/performed without anesthesia. The expected mean incremental difference between the total cost of delivery that includes ECV with anesthesia and ECV without anesthesia was $-276 (2.5th-97.5th percentile prediction interval $-720 to $112). CONCLUSION: The total cost of delivery in women with breech presentation may be decreased (up to $720) or increased (up to $112) if ECV is attempted/performed with neuraxial anesthesia compared with ECV without neuraxial anesthesia. Increased ECV success with neuraxial anesthesia and the subsequent reduction in breech cesarean delivery rate offset the costs of providing anesthesia to facilitate ECV.


Assuntos
Analgesia Epidural/economia , Apresentação Pélvica/economia , Versão Fetal/economia , Analgesia Epidural/métodos , Apresentação Pélvica/diagnóstico , Apresentação Pélvica/cirurgia , Custos e Análise de Custo/economia , Custos e Análise de Custo/métodos , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Versão Fetal/métodos
8.
Women Birth ; 26(1): e41-4, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23062234

RESUMO

UNLABELLED: For women with unsuccessful ECV, discussions about their mode of delivery should include the benefits and risks of a planned caesarean or vaginal breech birth. However, most obstetric units continue to offer only planned caesarean births when ECVs are unsuccessful despite the proven safety of vaginal breech births in selected patients. Such unit policies can be at variance with a woman's desire and preference for vaginal birth. Thus, a conflict situation arises that could have varying medical, emotional and cultural implications. AIM: To provide a consumer perspective on ECV from women who had an unsuccessful procedure. METHODOLOGY: A qualitative study involving focus group discussions with women who had unsuccessful ECV at secondary obstetric facility in Melbourne, Australia. RESULTS: Emergent themes from the focus group discussions were related to emotions associated with the inevitability of a caesarean section for breech, consequences of an unsuccessful ECV and the various activities undertaken by women to induce spontaneous version. CONCLUSION: A medicalized approach to ECV fell short of women's expectations of care. There is a need to develop strategies that will help women deal with any conflicts occasioned by an unsuccessful ECV.


Assuntos
Apresentação Pélvica/psicologia , Cesárea/psicologia , Mães/psicologia , Seleção de Pacientes , Versão Fetal/psicologia , Adulto , Austrália , Feminino , Grupos Focais , Idade Gestacional , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Gravidez , Resultado da Gravidez , Pesquisa Qualitativa , Versão Fetal/efeitos adversos , Adulto Jovem
9.
Health Econ ; 21(10): 1183-95, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21882285

RESUMO

Previous applications of value of information methods for determining optimal sample size in randomized clinical trials have assumed no between-study variation in mean incremental net benefit. By adopting a hierarchical model, we provide a solution for determining optimal sample size with this assumption relaxed. The solution is illustrated with two examples from the literature. Expected net gain increases with increasing between-study variation, reflecting the increased uncertainty in incremental net benefit and reduced extent to which data are borrowed from previous evidence. Hence, a trial can become optimal where current evidence is sufficient assuming no between-study variation. However, despite the expected net gain increasing, the optimal sample size in the illustrated examples is relatively insensitive to the amount of between-study variation. Further percentage losses in expected net gain were small even when choosing sample sizes that reflected widely different between-study variation.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Tamanho da Amostra , Cesárea/economia , Análise Custo-Benefício , Feminino , Humanos , Modelos Econômicos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Reprodutibilidade dos Testes , Versão Fetal/economia
11.
Complement Ther Med ; 18(2): 67-77, 2010 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-20430289

RESUMO

OBJECTIVES: To assess, using a modelling approach, the effectiveness and costs of breech version with acupuncture-type interventions on BL67 (BVA-T), including moxibustion, compared to expectant management for women with a foetal breech presentation at 33 weeks gestation. DESIGN: A decision tree was developed to predict the number of caesarean sections prevented by BVA-T compared to expectant management to rectify breech presentation. The model accounted for external cephalic versions (ECV), treatment compliance, and costs for 10,000 simulated breech presentations at 33 weeks gestational age. Event rates were taken from Dutch population data and the international literature, and the relative effectiveness of BVA-T was based on a specific meta-analysis. Sensitivity analyses were conducted to evaluate the robustness of the results. MAIN OUTCOME MEASURES: We calculated percentages of breech presentations at term, caesarean sections, and costs from the third-party payer perspective. Odds ratios (OR) and cost differences of BVA-T versus expectant management were calculated. (Probabilistic) sensitivity analysis and expected value of perfect information analysis were performed. RESULTS: The simulated outcomes demonstrated 32% breech presentations after BVA-T versus 53% with expectant management (OR 0.61, 95% CI 0.43, 0.83). The percentage caesarean section was 37% after BVA-T versus 50% with expectant management (OR 0.73, 95% CI 0.59, 0.88). The mean cost-savings per woman was euro 451 (95% CI euro 109, euro 775; p=0.005) using moxibustion. Sensitivity analysis showed that if 16% or more of women offered moxibustion complied, it was more effective and less costly than expectant management. To prevent one caesarean section, 7 women had to use BVA-T. The expected value of perfect information from further research was euro0.32 per woman. CONCLUSIONS: The results suggest that offering BVA-T to women with a breech foetus at 33 weeks gestation reduces the number of breech presentations at term, thus reducing the number of caesarean sections, and is cost-effective compared to expectant management, including external cephalic version.


Assuntos
Terapia por Acupuntura/economia , Terapia por Acupuntura/métodos , Apresentação Pélvica/terapia , Simulação por Computador , Cesárea/economia , Análise Custo-Benefício , Árvores de Decisões , Feminino , Ginecologia/economia , Ginecologia/métodos , Humanos , Tocologia/economia , Tocologia/métodos , Moxibustão/economia , Moxibustão/métodos , Razão de Chances , Cooperação do Paciente , Gravidez , Versão Fetal/economia
12.
BMC Pregnancy Childbirth ; 10: 20, 2010 May 10.
Artigo em Inglês | MEDLINE | ID: mdl-20459717

RESUMO

BACKGROUND: Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch Society for Obstetrics and Gynaecology (NVOG). Implementation of ECV does not exceed 50 to 60% and probably less.We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling. METHOD/DESIGN: The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV.The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured. DISCUSSION: This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term. TRIAL REGISTRATION: Dutch Trial Register (NTR): 1878.


Assuntos
Apresentação Pélvica/terapia , Difusão de Inovações , Fidelidade a Diretrizes/organização & administração , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/organização & administração , Versão Fetal , Apresentação Pélvica/epidemiologia , Cesárea/estatística & dados numéricos , Análise Custo-Benefício , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Países Baixos/epidemiologia , Enfermeiros Obstétricos/educação , Enfermeiros Obstétricos/organização & administração , Obstetrícia/educação , Obstetrícia/organização & administração , Avaliação de Processos e Resultados em Cuidados de Saúde , Educação de Pacientes como Assunto , Padrões de Prática em Enfermagem/organização & administração , Gravidez , Projetos de Pesquisa , Versão Fetal/educação , Versão Fetal/estatística & dados numéricos
13.
BMC Pregnancy Childbirth ; 10: 3, 2010 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-20092630

RESUMO

BACKGROUND: External cephalic version (ECV) is recommended by the American College of Obstetricians and Gynecologists to convert a breech fetus to vertex position and reduce the need for cesarean delivery. The goal of this study was to determine the incremental cost-effectiveness ratio, from society's perspective, of ECV compared to scheduled cesarean for term breech presentation. METHODS: A computer-based decision model (TreeAge Pro 2008, Tree Age Software, Inc.) was developed for a hypothetical base case parturient presenting with a term singleton breech fetus with no contraindications for vaginal delivery. The model incorporated actual hospital costs (e.g., $8,023 for cesarean and $5,581 for vaginal delivery), utilities to quantify health-related quality of life, and probabilities based on analysis of published literature of successful ECV trial, spontaneous reversion, mode of delivery, and need for unanticipated emergency cesarean delivery. The primary endpoint was the incremental cost-effectiveness ratio in dollars per quality-adjusted year of life gained. A threshold of $50,000 per quality-adjusted life-years (QALY) was used to determine cost-effectiveness. RESULTS: The incremental cost-effectiveness of ECV, assuming a baseline 58% success rate, equaled $7,900/QALY. If the estimated probability of successful ECV is less than 32%, then ECV costs more to society and has poorer QALYs for the patient. However, as the probability of successful ECV was between 32% and 63%, ECV cost more than cesarean delivery but with greater associated QALY such that the cost-effectiveness ratio was less than $50,000/QALY. If the probability of successful ECV was greater than 63%, the computer modeling indicated that a trial of ECV is less costly and with better QALYs than a scheduled cesarean. The cost-effectiveness of a trial of ECV is most sensitive to its probability of success, and not to the probabilities of a cesarean after ECV, spontaneous reversion to breech, successful second ECV trial, or adverse outcome from emergency cesarean. CONCLUSIONS: From society's perspective, ECV trial is cost-effective when compared to a scheduled cesarean for breech presentation provided the probability of successful ECV is > 32%. Improved algorithms are needed to more precisely estimate the likelihood that a patient will have a successful ECV.


Assuntos
Apresentação Pélvica/terapia , Cesárea/economia , Versão Fetal/economia , Apresentação Pélvica/epidemiologia , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Emergências/economia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde , Nível de Saúde , Humanos , Modelos Econométricos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Gravidez , Resultado da Gravidez/economia , Anos de Vida Ajustados por Qualidade de Vida , Estados Unidos/epidemiologia
14.
J Perinat Med ; 37(4): 334-7, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19290855

RESUMO

External cephalic version (ECV) at term is a safe procedure and reduces the incidence of cesarean sections for breech presentation. One of the known complications, however, is an ECV-related disruption of the placental barrier and a subsequent transfusion of fetal blood into maternal circulation. While the incidence of ECV-related fetomaternal hemorrhage (FMH) has been determined recently in a large trial using a manual Kleihauer-Betke test (KBT), questions remain on the amount of ECV-related FMH. KBT, which detects fetal red blood cells (RBC) on the basis of acidic resistance of fetal hemoglobin (HbF), is known to be a sensitive test, yet prone to procedural errors limiting its accuracy in quantifying FMH. In this study we investigated 50 patients for FMH before and after ECV, using a dual-color flow cytometric test kit with a lower limit of quantification of 0.05% fetal RBC in maternal peripheral blood. Three patients had a quantifiable increase of fetal RBC detected after ECV (0.06%; 0.08%; 0.1%). None of these subtle increments was predictable by ECV-related clinical parameters or translated into fetal compromise. Using a sensitive and accurate flow cytometric test method, our data provide further assurance to mothers on the safety of ECV at term.


Assuntos
Transfusão Feto-Materna/etiologia , Versão Fetal/efeitos adversos , Contagem de Eritrócitos , Feminino , Citometria de Fluxo , Humanos , Gravidez , Estudos Prospectivos
15.
Health Econ ; 18(2): 203-16, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18435429

RESUMO

Value of information methods allows decision makers to identify efficient trial design following a principle of maximizing the expected value to decision makers of information from potential trial designs relative to their expected cost. However, in health technology assessment (HTA) the restrictive assumption has been made that, prospectively, there is only expected value of sample information from research commissioned within jurisdiction. This paper extends the framework for optimal trial design and decision making within jurisdiction to allow for optimal trial design across jurisdictions. This is illustrated in identifying an optimal trial design for decision making across the US, the UK and Australia for early versus late external cephalic version for pregnant women presenting in the breech position. The expected net gain from locally optimal trial designs of US$0.72M is shown to increase to US$1.14M with a globally optimal trial design. In general, the proposed method of globally optimal trial design improves on optimal trial design within jurisdictions by: (i) reflecting the global value of non-rival information; (ii) allowing optimal allocation of trial sample across jurisdictions; (iii) avoiding market failure associated with free-rider effects, sub-optimal spreading of fixed costs and heterogeneity of trial information with multiple trials.


Assuntos
Análise Custo-Benefício , Tomada de Decisões Gerenciais , Modelos Econômicos , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Programas Médicos Regionais/economia , Apoio à Pesquisa como Assunto/economia , Avaliação da Tecnologia Biomédica/métodos , Austrália , Comparação Transcultural , Difusão de Inovações , Feminino , Humanos , Estudos Multicêntricos como Assunto/economia , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Tamanho da Amostra , Avaliação da Tecnologia Biomédica/economia , Reino Unido , Estados Unidos , Versão Fetal/economia
16.
Clin Trials ; 5(4): 289-300, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18697843

RESUMO

BACKGROUND: Traditional sample size calculations for randomized clinical trials depend on somewhat arbitrarily chosen factors, such as Type I and II errors. An effectiveness trial (otherwise known as a pragmatic trial or management trial) is essentially an effort to inform decision-making, i.e., should treatment be adopted over standard? Taking a societal perspective and using Bayesian decision theory, Willan and Pinto (Stat. Med. 2005; 24:1791-1806 and Stat. Med. 2006; 25:720) show how to determine the sample size that maximizes the expected net gain, i.e., the difference between the cost of doing the trial and the value of the information gained from the results. METHODS: These methods are extended to include multi-stage adaptive designs, with a solution given for a two-stage design. The methods are applied to two examples. RESULTS: As demonstrated by the two examples, substantial increases in the expected net gain (ENG) can be realized by using multi-stage adaptive designs based on expected value of information methods. In addition, the expected sample size and total cost may be reduced. LIMITATIONS: Exact solutions have been provided for the two-stage design. Solutions for higher-order designs may prove to be prohibitively complex and approximate solutions may be required. CONCLUSIONS: The use of multi-stage adaptive designs for randomized clinical trials based on expected value of sample information methods leads to substantial gains in the ENG and reductions in the expected sample size and total cost.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Antineoplásicos/uso terapêutico , Teorema de Bayes , Viés , Custos e Análise de Custo , Teoria da Decisão , Feminino , Humanos , Masculino , Gravidez , Neoplasias da Próstata/tratamento farmacológico , Tamanho da Amostra , Versão Fetal/métodos
17.
Ned Tijdschr Geneeskd ; 152(23): 1323-8, 2008 Jun 07.
Artigo em Holandês | MEDLINE | ID: mdl-18661859

RESUMO

OBJECTIVE: Identification of determinants affecting the outcome of external cephalic version (ECV) in breech presentation, and investigation of the impact of ECV--performed according to a standardized protocol in an outpatient clinic--on the mode of delivery. DESIGN: Retrospective analysis. METHOD: In 2003 a standardized protocol of ECV was developed in the outpatient clinic for obstetrics of the Catharina Hospital in Eindhoven, the Netherlands; it was tested in 'version office visits'. Obstetric characteristics of all pregnant women who underwent attempts of ECV in the clinic from January 2004 until June 2006 during these sessions, and the subsequent births, were analysed. 85% of all ECVs were performed by the same hospital midwife and gynaecologist, in accordance with the protocol. RESULTS: ECV was successful in 96 of 209 pregnant women (46%). In 1 pregnant woman an emergency caesarean section was performed after ECV because of partial abruptio placentae. Nulliparity, incomplete breech presentation and low birth weight of the baby were associated with a lower success rate of ECV in this study. In the group with a successful ECV the percentage of caesarean deliveries was substantially lower (9 versus 83%; odds ratio: 0.21; 95% CI: 0.09-0.51). CONCLUSION: A regular team consisting of a hospital midwife and a gynaecologist working according to a standardized protocol for ECV in a case of breech presentation proved successful: the number of term breech presentations substantially diminished and therefore the percentage of caesarean sections was lower in the group in which ECV had been successful. This could have considerable impact on health care in the Netherlands in terms of reduced maternal morbidity and cost savings.


Assuntos
Apresentação Pélvica/terapia , Competência Clínica , Obstetrícia/normas , Versão Fetal/métodos , Adulto , Apresentação Pélvica/cirurgia , Cesárea/estatística & dados numéricos , Análise Custo-Benefício , Feminino , Humanos , Tocologia/normas , Países Baixos , Gravidez , Resultado da Gravidez , Estudos Retrospectivos
19.
Midwifery ; 24(1): 38-45, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17196716

RESUMO

BACKGROUND: to evaluate the effectiveness of external cephalic version (ECV) without tocolysis or epidural analgesia, the complications associated with the procedure and the association between the number of ECV attempts and cephalic presentation at birth and caesarean section. METHODS: retrospective cohort study of all (n=924) ECVs carried out between 1996 and 2000 in a specialised midwifery centre in the Netherlands. After bivariate analysis, those variables with a p value under 0.05 were considered statistically significant and were tested in a logistic regression model using backward stepwise selection. Analyses were carried out separately for first ECV attempts and second ECV attempts. FINDINGS: in total, 958 ECVs were analysed, 889 first attempts and 69 repeat attempts. Seventy per cent of all first ECVs were carried out before 37 weeks, but half of those were carried out between 36 and 37 weeks. The success rate for first ECV was 41% and for the second ECV 29%. Bivariate analysis showed that the success of the first ECV was positively influenced by parity, non-Dutch origin, higher birth weight, higher age and longer duration of pregnancy. After logistic regression, parity (odds ratio [OR] 2.8, 95% CI 2.1 to 3.7), non-Dutch origin (OR 1.8, 95% CI 1.2 to 2.8) and birth weight (OR 1.7, 95% CI 1.4 to 2.0) remained factors that independently influenced the success of ECV. The odds ratio for duration of pregnancy at first ECV was borderline significant: OR 1.2 (1.0 to 1.4). After an unsuccessful first ECV, only 13% of the women received a second ECV. The prevalence of cephalic presentation at birth increased with 3% after a second ECV. Three cases of complications were reported during or very shortly after the first ECV, and these did not result in serious complications. No complications were reported after a second ECV. CONCLUSION: ECV without tocolysis is a safe procedure for pregnant women and their babies. Repeat ECV increases the number of cephalic presentations at birth and should be considered after an unsuccessful ECV.


Assuntos
Competência Clínica , Tocologia/organização & administração , Papel do Profissional de Enfermagem , Resultado da Gravidez/epidemiologia , Versão Fetal/enfermagem , Adulto , Apresentação Pélvica/enfermagem , Estudos de Coortes , Intervalos de Confiança , Feminino , Humanos , Recém-Nascido , Países Baixos/epidemiologia , Relações Enfermeiro-Paciente , Razão de Chances , Aceitação pelo Paciente de Cuidados de Saúde , Participação do Paciente , Gravidez , Terceiro Trimestre da Gravidez , Estudos Retrospectivos , Tocólise , Versão Fetal/estatística & dados numéricos
20.
BMC Health Serv Res ; 1: 6, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11472641

RESUMO

OBJECTIVE: To determine the care pathways and implications of offering mothers the choice of external cephalic version (ECV) at term for singleton babies who present with an uncomplicated breech pregnancy versus assisted breech delivery or elective caesarean. DESIGN: A prospective observational audit to construct a decision analysis of uncomplicated full term breech presentations. SETTING: The North Staffordshire NHS Trust. SUBJECTS: All women (n = 176) who presented at full term with a breech baby without complications during July 1995 and June 1997. MAIN OUTCOME MEASURES: The study determined to compare the outcome in terms of the costs and cost consequences for the care pathways that resulted from whether a women chose to accept the offer of ECV or not. All the associated events were then mapped for the two possible pathways. The costs were considered only within the hospital setting, from the perspective of the health care provider up to the point of delivery. RESULTS: The additional costs for ECV, assisted breech delivery and elective caesarean over and above a normal birth were 186.70 pounds sterling, 425.36 pounds sterling and 1,955.22 pounds sterling respectively. The total expected cost of the respective care pathways for "ECV accepted" and "ECV not accepted" (including the probability of adverse events) were 1,452 pounds sterling and 1,828 pounds sterling respectively, that is the cost of delivery through the ECV care pathways is less costly than the non ECV delivery care pathway. CONCLUSIONS: Implementing an ECV service may yield cost savings in secondary care over and above the traditional delivery methods for breech birth of assisted delivery or caesarean section. The scale of these expected cost savings are in the range of 248 pounds sterling to 376 pounds sterling per patient. This converts to a total expected cost saving of between 43,616 pounds sterling and 44,544 pounds sterling for the patient cohort considered in this study.


Assuntos
Apresentação Pélvica , Cesárea/economia , Procedimentos Clínicos , Técnicas de Apoio para a Decisão , Custos Hospitalares/estatística & dados numéricos , Versão Fetal/economia , Adulto , Cesárea/estatística & dados numéricos , Comportamento de Escolha , Estudos de Coortes , Redução de Custos , Árvores de Decisões , Parto Obstétrico/economia , Parto Obstétrico/métodos , Feminino , Custos Hospitalares/classificação , Hospitais de Distrito/economia , Hospitais Gerais/economia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Participação do Paciente , Gravidez , Reino Unido , Versão Fetal/estatística & dados numéricos
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