Reanalysis of a Muitireported Trial on Home Uterine Activity Monitoring

Authors

  • Marc J.N.C. Keirse MD, DPhil,

    Corresponding author
    1. Marc Keirse is Professor of Obstetrics and Chair of the University Department of Obstetrics, Gynecology, and Reproduction at Leiden University, The Netherlands. Marion van Hoven was a clinical research trainee at the same department and is a resident in Obstetrics and Gynecology at Nijmegen University Hospital, The Netherlands.
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  • Marion Van Hoven MD

    1. Marc Keirse is Professor of Obstetrics and Chair of the University Department of Obstetrics, Gynecology, and Reproduction at Leiden University, The Netherlands. Marion van Hoven was a clinical research trainee at the same department and is a resident in Obstetrics and Gynecology at Nijmegen University Hospital, The Netherlands.
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Address correspondence to Marc J.N.C. Keirse, MD, DPhil, Department of Obstetrics, Gynecology and Reproduction, Leiden University Hospital, PO Box 9600, NL-2300 RC Leiden, The Netherlands.

ABSTRACT

A randomized multicenter study of home uterine activity monitoring using the “Term Guard,” is widely cited in support of the Term Guard monitoring system. Critical appraisal of the data in the six reports of the study showed that all reports scored poorly on avoidance of allocation, exclusion, and assessment bias. In all of them the numbers of women for whom outcomes were reported were different, and none provided information on infant outcomes. Comparison of analyses and subanalyses showed inconsistencies that defied the laws of arithmetic. Reanalysis of the data, as well as could be done from the available information, showed that use of the Term Guard system was compatible with both an increase and a decrease in the frequency of preterm delivery (95% CI +2.2% to 16.5%). It is concluded that the reports of the multicenter study contain such high potential for bias and so many internal inconsistencies that they should be dismissed entirely. (BIRTH 20:3, September 1993)

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