Home uterine activity monitoring: the role of medical evidence.
The current paradigm in obstetrics has shifted toward evidence-based medicine, and yet in clinical practice physicians continue to use interventions for which there exists no credible evidence. This article examines the U.S. Food and Drug Administration (FDA) status of home uterine activity monitoring (HUAM) and the published clinical trials examining HUAM for the management of current preterm labor. The use of HUAM was introduced into clinical practice and heavily marketed without benefit of scientific rigor. Gradually, HUAM use migrated primarily for patients diagnosed (or misdiagnosed) with preterm labor in the current pregnancy who are stabilized and sent home with or without a tocolytic. This clinical intervention has not been cleared by the FDA, has virtually no scientific support, and constitutes a gross deviation from evidence-based medicine. As obstetricians accept the role of medical evidence steering clinical practice, HUAM clearly has no clinical value and therefore should not be used to manage patients outside of a randomized controlled clinical trial.
Reichmann
James P
JP
jim.reichmann@ahom.com
D000328:Adult; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D018670:Monitoring, Ambulatory; D007752:Obstetric Labor, Premature / Q000175:diagnosis*; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration; D018590:Uterine Monitoring / Q000379:methods