Liever inleiden dan afwachten bij aterme zwangerschapshypertensie en milde preeclampsie: HYPITAT-studie

OBJECTIVE: To investigate what would benefit women with mild full-term pregnancy-related hypertension most: induction of labour or expectant monitoring, from the perspective of clinical effectiveness, maternal quality of life, and costs. DESIGN: Randomised clinical trial. Trial registration number ISRCTN08132825. METHODS: We undertook a multicentre randomised controlled trial in 38 hospitals in the Netherlands between October 2005 and March 2008. We enrolled patients with a singleton pregnancy in cephalic presentation at 36-41 weeks' gestation, who had gestational hypertension or mild preeclampsia. Participants were randomly allocated to receive either induction of labour or expectant monitoring. The primary outcome was a composite measure of poor maternal outcome, defined as maternal mortality, maternal morbidity (eclampsia, 'haemolysis, elevated liver enzymes, low platelets' (HELLP) syndrome, pulmonary oedema, thrombo-embolic disease and abruptio placentae), progression to severe hypertension or proteinuria, and major postpartum haemorrhage. Secondary outcomes were mode of delivery, neonatal outcome, maternal quality of life and costs. Analysis was by intention to treat. RESULTS: A total of 756 patients were allocated to receive induction of labour (n = 377 patients) or expectant monitoring (n = 379). No cases of maternal or neonatal death or eclampsia were recorded. Development of poor maternal outcome was significantly lower in the induction of labour group (117 women) than the expectant monitoring group (166 women) (31% versus 44%; relative risk 0.71 (95% CI: 0.59-0.86); p < 0.001). The caesarean section rate was lower among women in the induction of labour group (n = 54) compared to women in the expectant monitoring group (n = 72) (14% versus 19%; relative risk 0.75 (95% CI: 0.55-1.04)< p = 0.085). Neonatal outcomes and quality of life were comparable between both groups. Induction of labour is a cost saving strategy (difference euro 831). CONCLUSION: For women with full-term gestational hypertension and pre-eclampsia, induction of labour is associated with improved maternal outcome and lower costs, without the additional risk of a caesarean section being necessary

Preaxial polydactyly in the 4p- syndrome

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The impact of contact quality between expatriate and local host on the success of the international assignment: an empirical study

Developmen

Cost-effectiveness of cardiotocography plus ST analysis of the fetal electrocardiogram compared with cardiotocography only

OBJECTIVE. To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN®) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only. DESIGN. Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG. SETTING. Obstetric departments of three academic and six general hospitals in The Netherlands. POPULATION. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age > 36 weeks and an indication for internal electronic fetal monitoring. METHODS. A trial-based cost-effectiveness analysis was performed froma health-care provider perspective. MAIN OUTCOME MEASURES. Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costswere estimated fromstart of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis. RESULTS. The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38–1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n = 2 827) were €1 345 vs. €1 316 for CTG only (n=2 840), with a mean difference of €29 (95% confidence interval −€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667. CONCLUSIONS. The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery.Sylvia M.C. Vijgen ... Ben Willem J. Mol ... et al

Identification of cases with adverse neonatal outcome monitored by cardiotocography versus ST analysis: secondary analysis of a randomized trial

OBJECTIVE: To evaluate whether correct adherence to clinical guidelines might have led to prevention of cases with adverse neonatal outcome. DESIGN: Secondary analysis of cases with adverse outcome in a multicenter randomized clinical trial. SETTING: Nine Dutch hospitals. POPULATION: Pregnant women with a term singleton fetus in cephalic position. METHODS: Data were obtained from a randomized trial that compared monitoring by STAN® (index group) with cardiotocography (control group). In both trial arms, three observers independently assessed the fetal surveillance results in all cases with adverse neonatal outcome, to determine whether an indication for intervention was present, based on current clinical guidelines. MAIN OUTCOME MEASURES: Adverse neonatal outcome cases fulfilled one or more of the following criteria: (i) metabolic acidosis in umbilical cord artery (pH 12 mmol/L); (ii) umbilical cord artery pH < 7.00; (iii) perinatal death; and/or (iv) signs of moderate or severe hypoxic ischemic encephalopathy. RESULTS: We studied 5681 women, of whom 61 (1.1%) had an adverse outcome (26 index; 35 control). In these women, the number of performed operative deliveries for fetal distress was 18 (69.2%) and 16 (45.7%), respectively. Reassessment of all 61 cases showed that there was a fetal indication to intervene in 23 (88.5%) and 19 (57.6%) cases, respectively. In 13 (50.0%) vs. 11 (33.3%) cases, respectively, this indication occurred more than 20 min before the time of delivery, meaning that these adverse outcomes could possibly have been prevented. CONCLUSIONS: In our trial, more strict adherence to clinical guidelines could have led to additional identification and prevention of adverse outcome.Michelle E.M.H. Westerhuis ... Ben Willem J. Mol ... et al

Prediction of Neonatal Metabolic Acidosis in Women with a Singleton Term Pregnancy in Cephalic Presentation

Research into fetal development and medicin

Prediction of neonatal metaboic acidos in women with a singleton term pregnancy in cephalic presentation

We sought to predict neonatal metabolic acidosis at birth using antepartum obstetric characteristics (model 1) and additional characteristics available during labor (model 2). In 5667 laboring women from a multicenter randomized trial that had a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation, we predicted neonatal metabolic acidosis. Based on literature and clinical reasoning, we selected both antepartum characteristics and characteristics that became available during labor. After univariable analyses, the predictors of the multivariable models were identified by backward stepwise selection in a logistic regression analysis. Model performance was assessed by discrimination and calibration. To correct for potential overfitting, we (internally) validated the models with bootstrapping techniques. Of 5667 neonates born alive, 107 (1.9%) had metabolic acidosis. Antepartum predictors of metabolic acidosis were gestational age, nulliparity, previous cesarean delivery, and maternal diabetes. Additional intrapartum predictors were spontaneous onset of labor and meconium-stained amniotic fluid. Calibration and discrimination were acceptable for both models (c-statistic 0.64 and 0.66, respectively). In women with a high-risk singleton term pregnancy in cephalic presentation, we identified antepartum and intrapartum factors that predict neonatal metabolic acidosis at birth

Cardiotocography plus ST analysis of fetal electrocardiogram compared with cardiotocography only for intrapartum monitoring: a randomized controlled trial

OBJECTIVE: To estimate the effectiveness of intrapartum fetal monitoring by cardiotocography plus ST analysis using a strict protocol for performance of fetal blood sampling. METHODS: We performed a multicenter randomized trial among laboring women with a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation. Participants were assigned to monitoring by cardiotocography with ST analysis (index) or cardiotocography only (control). Primary outcome was metabolic acidosis, defined as an umbilical cord artery pH below 7.05 combined with a base deficit calculated in the extracellular fluid compartment above 12 mmol/L. Secondary outcomes were metabolic acidosis in blood, operative deliveries, Apgar scores, neonatal admissions, and hypoxic–ischemic encephalopathy. RESULTS: We randomly assigned 5,681 women to the two groups (2,832 index, 2,849 control). The fetal blood sampling rate was 10.6% in the index compared with 20.4% in the control group (relative risk 0.52; 95% [CI] 0.46–0.59). The primary outcome occurred 0.7% in the index compared with 1.1% in the control group (relative risk 0.70; 95% CI 0.38–1.28; number needed to treat 252). Using metabolic acidosis calculated in blood, these rates were 1.6% and 2.6%, respectively (relative risk 0.63; 95% CI 0.42–0.94; number needed to treat 100). The number of operative deliveries, low Apgar scores, neonatal admissions, and newborns with hypoxic–ischemic encephalopathy was comparable in both groups. CONCLUSION: Intrapartum monitoring by cardiotocography combined with ST analysis does not significantly reduce the incidence of metabolic acidosis calculated in the extracellular fluid compartment. It does reduce the incidence of metabolic acidosis calculated in blood and the need for fetal blood sampling without affecting the Apgar score, neonatal admissions, hypoxic–ischemic encephalopathy, or operative deliveries. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.isrctn.org, ISRCTN95732366. LEVEL OF EVIDENCE: IMichelle E. M. H. Westerhuis, Gerard H. A. Visser, Karel G. M. Moons, Erik van Beek, Manon J. Benders, Saskia M. Bijvoet, Hendrikus J. H. M. van Dessel, Addy P. Drogtrop, Herman P. van Geijn, Giuseppe C. Graziosi, Floris Groenendaal, Jan M. M. van Lith, Jan G. Nijhuis, S. Guid Oei, Herman P. Oosterbaan, Martina M. Porath, Robbert J. P. Rijnders, Nico W. E. Schuitemaker, Louisa M. Sopacua, Ingeborg van der Tweel, Lia D. E. Wijnberger, Christine Willekes, Nicolaas P. A. Zuithoff, Ben Willem J. Mol, and Anneke Kwe