Abstract
AbstractRecording of fetal heart rate via CTG monitoring has been routinely performed as an important part of antenatal and subpartum care for several decades. The current guidelines of the FIGO (ref1) recommend a normal range of the fetal heart rate from 110 to 150 bpm. However, there is no agreement in the medical community whether this is the correct range (ref2). We aim to address this question by computerized analysis (ref 3) of a high quality database (HQDb, ref 4) of about one billion electronically registered fetal heart rate measurements from about 10,000 pregnancies in three medical centres over seven years. In the present paper, we lay out a detailed analysis plan for this evidence-based project in the vein of the validation policy of the Sylvia Lawry Centre for Multiple Sclerosis Research (ref 5) with a split of the database into an exploratory part and a part reserved for validation. We will perform the analysis and the validation after publication of this plan in order to reduce the probability of publishing false positive research findings (ref 6-7).
Highlights
Recording of fetal heart rate via CTG monitoring has been routinely performed as an important part of antenatal and subpartum care for several decades
The most frequently cited intervals are 110-150 bpm and 120-160 bpm, whereas 115160 bpm and 110-160 bpm are used by a smaller number of clinicians. We address this crucial issue from the point of view of clinical informatics, based on about one billion individual fetal heart rate measurements
Based on 250,000,000 individual fetal heart rate measurements, a preliminary study using the data from the hospital “Rechts der Isar” (Munich, Germany) for 2000 and 2001 revealed that the currently recommended normal ranges [110, 150 bpm] are inappropriate and should be shifted to [115, 160 bpm]
Summary
Recording of fetal heart rate via CTG monitoring has been routinely performed as an important part of antenatal and subpartum care for several decades. We address this crucial issue from the point of view of clinical informatics, based on about one billion individual fetal heart rate measurements. Based on 250,000,000 individual fetal heart rate measurements, a preliminary study using the data from the hospital “Rechts der Isar” (Munich, Germany) for 2000 and 2001 revealed that the currently recommended normal ranges [110, 150 bpm] (ref 8) are inappropriate and should be shifted to [115, 160 bpm]. This might reduce the number of false alarms, a big problem in clinical practice. If the result is different for at least one of the validation data sets, we will pool all four data sets and use them to suggest an interval (based on the same methodology) that will have to be validated in further research
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