Publications (3)41.11 Total impact
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Article: Correction: Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial.
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ABSTRACT: ABSTRACT: The initial sample size calculation in our protocol (Hegeman et al, BMC Pregnancy Childbirth, 2009, 9:44) was based on the expected proportion of 'bad neonatal outcome' in the intervention group (3.9%) and control group (7.2%) and accounts for the fact that the outcomes in children form multiple pregnancies are non-independent using an intra class correlation of 0.6. As the intervention is performed on the mother, analysis should be done on the maternal level. This adjustment was made during recruitment and approved by the medical ethics committee of the Academic Medical Centre in Amsterdam (ref. No. MEC 09/107). The sample size is calculated based on the primary outcome 'bad neonatal outcome'.BMC Pregnancy and Childbirth 05/2012; 12:37. · 2.83 Impact Factor -
Article: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.
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ABSTRACT: Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded. Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. ZonMw.The Lancet 08/2009; 374(9694):979-88. · 38.28 Impact Factor -
Article: Well being of obstetric patients on minimal blood transfusions (WOMB trial)
