jueves, 21 de marzo de 2019

Recruitment of pregnant women in randomized trials: What could hold us back? - BMC Series blog

Recruitment of pregnant women in randomized trials: What could hold us back? - BMC Series blog

Indira Van Der Zande, Job Klumper, Martijn Oudijk & Carolien Dijkstra-Roos

Indira van der Zande obtained her PhD in research ethics at the University Medical Center Utrecht, at the Julius Center for Health Sciences and Primary Care department. Her topic concerned the fair inclusion of pregnant women in clinical research, combining an empirical design with normative reflection in her methodology.Indira is currently employed at the University of Groningen, where she works as Programme Director for the BSc Global Responsibility & Leadership at University College Fryslân.

Dr Job Klumper obtained his medical degree in at the University Medical Center Utrecht, and worked as a resident obstetrics and gynaecology. Currently he works as a PhD student on the APOSTEL 8 trial.

Dr Martijn Oudijk is a consultant obstetrician at the Amsterdam UMC, specialized in high risk pregnancy and preterm birth. He is chairman of the division of Fetal-Maternal Medicine, chairman of the scientific committee of the division of Fetal-Maternal Medicine and former chairman of the Obstetrics board of Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology. He is principal investigator of two completed large national RCT’s on treatment of preterm birth and is principal investigator of the current studies APRIL, APOSTEL III Follow-up study and the APOSTEL 8 study.

Dr Carolien Dijkstra-Roos is a consultant obstetrician, currently working as a Fellow Perinatology at the Amsterdam UMC. Within this fellowship she specializes in preterm birth and high risk pregnancy. She was involved in the project groups of the completed studies on tocolysis in preterm labor, the APOSTEL II, the APOSTEL II Follow-up study and the IPD meta-analysis on maintenance tocolysis with nifedipine. Currently she is part of the project group of a large international placebo controlled RCT on tocolysis, the APOSTEL 8 study.




Recruitment of pregnant women in randomized trials: What could hold us back?

For many years, members of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology (NVOG Consortium) have been working on the improvement of care for patients with threatened preterm birth. One of the research topics, the safety and effectiveness of labor-suppressing tocolytic medications, is covered in the APOSTEL trials. In this blog, we would like to outline the APOSTEL trials that have been performed so far, provide an update on the current project, the APOSTEL 8 trial, and provide different stakeholders’ views on recruitment of pregnant women in randomized trials from our recent paper in BMC Pregnancy and Childbirth.
The APOSTEL line of trials has covered APOSTEL I-VII so far. APOSTEL stands for ‘Assessment of Perinatal Outcome with [S….] Tocolysis in Early Labor’ – in this acronym the ‘S’ had different meanings in the different APOSTEL trials. These trials are summarized in Table 1. The most recent publication related to these trials describes stakeholders’ views on recruitment of pregnant women in randomized trials using data gathered during the APOSTEL VI trial.

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