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The Normal Fetal Heart Rate Study: Analysis Plan

Martin Daumer¹, Michael Scholz², Anne-Laure Boulesteix³, Stephanie Pildner von Steinburg⁴, Sven Schiermeier⁵, Wolfgang Hatzmann⁵ & K T M Schneider⁴

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1. Sylvia Lawry Centre for Multiple Sclerosis Research e.V., Munich; Trium Analysis Online GmbH, Munich, Germany
2. Trium Analysis Online GmbH, Munich, Germany
3. Sylvia Lawry Centre for Multiple Sclerosis Research e.V., Munich; Department of Obstetrics and Gynecology, Technical University of Munich, Germany
4. Department of Obstetrics and Gynecology, Technical University of Munich, Germany
5. Department of Obstetrics and Gynecology, University Witten/Herdecke, Germany

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Document Type:

Manuscript

Date:

Received 12 September 2007 11:57 UTC; Posted 17 September 2007

Subjects:

Bioinformatics

Tags:

• Fetal Heart rate
• pregnancy analysis
• CTG monitoring
• statistics

Abstract:

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 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).

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License:

This document is licensed to the public under the Creative Commons Attribution 2.5 License

How to cite this document:

Daumer, Martin, Scholz, Michael, Boulesteix, Anne-Laure, Pildner von Steinburg, Stephanie, Schiermeier, Sven, Hatzmann, Wolfgang, and Schneider, K T M. The Normal Fetal Heart Rate Study: Analysis Plan. Available from Nature Precedings <http://dx.doi.org/10.1038/npre.2007.980.1> (2007)

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Version number	Document title	Date
v2	Posted 12 November 2007

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