Showing papers by "Pisake Lumbiganon published in 2001"
TL;DR: A model with a reduced number of antenatal visits, with or without goal-oriented components, could be introduced into clinical practice without risk to mother or baby, but some degree of dissatisfaction by the mother could be expected.
434 citations
TL;DR: A multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour and the use of additional uterotonics without an unacceptable level of side-effects.
318 citations
TL;DR: The use of antibiotic prophylaxis in cesarean section was variable and often at odds with published recommendations.
42 citations
TL;DR: The ethical aspects regarding informed consent are reviewed, concluding that the Zelen design has a place in cluster randomization trials and the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods is described.
Abstract: The World Health Organization and collaborating institutions in four developing countries have conducted a multi-centre randomized controlled trial, in which clinics were allocated at random to two antenatal care (ANC) models. These were the standard Western' ANC model and a new' ANC model consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. The two models were compared using the equivalence approach. This paper discusses the implications of the equivalence approach in the sample size calculation, analysis and interpretation of results of this cluster randomized trial. It reviews the ethical aspects regarding informed consent, concluding that the Zelen design has a place in cluster randomization trials. It describes the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods and reports estimates of the ICC obtained for many maternal, newborn and perinatal outcomes. Finally, it discusses analytical problems that arose: issues encountered using a composite index, heterogeneity of the intervention effect across sites, the choice of the method of analysis and the importance of efficacy analyses. The choice of the clustered Woolf estimator and the generalized estimating equations (GEE) as the methods of analysis applied is discussed.
34 citations