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Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention-to-treat principle.
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2011 (English)In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, ISSN 0001-6349, Vol. 90, no 9, p. 990-996Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To undertake a renewed analysis of data from the previously published Swedish randomized controlled trial on intrapartum fetal monitoring with cardiotocography (CTG-only) vs. CTG plus ST analysis of fetal electrocardiogram (CTG+ST), using current standards of intention-to-treat (ITT) analysis and to compare the results with those of the modified ITT (mITT) and per protocol analyses. METHODS: Renewed extraction of data from the original database including all cases randomized according to primary case allocation (n=5 049). MAIN OUTCOME MEASURE: Metabolic acidosis in umbilical artery at birth (pH <7.05, base deficit in extracellular fluid >12.0 mmol/l) including samples of umbilical vein blood or neonatal blood if umbilical artery blood was missing. RESULTS: The metabolic acidosis rates were 0.66% (17 of 2 565) and 1.33% (33 of 2 484) in the CTG+ST and CTG-only groups, respectively [relative risk (RR) 0.50; 95% confidence interval (CI) 0.28-0.88; p=0.019]. The original mITT gave RR 0.47, 95%CI 0.25-0.86 (p=0.015), mITT with correction for 10 previously misclassified cases RR 0.48, 95%CI 0.24-0.96 (p=0.038) and per protocol analysis RR 0.40, 95%CI 0.20-0.80 (p=0.009). The level of significance of the difference in metabolic acidosis rates between the two groups remained unchanged in all analyses. CONCLUSION: Re-analysis of data according to the ITT principle showed that regardless of the method of analysis, the Swedish randomized controlled trial maintained its ability to demonstrate a significant reduction in metabolic acidosis rate when using CTG+ST analysis for fetal surveillance in labor.

Place, publisher, year, edition, pages
John Wiley & Sons Ltd. , 2011. Vol. 90, no 9, p. 990-996
Keywords [en]
randomized controlled trial, cardiotocography/methods, delivery, obstetric/methods, electrocardiography, female, heart rate, humans, fetal, intention, intention to treat analysis, labor, pregnancy, obstetric, pregnancy outcome, sweden, Medicinteknik
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Biomedical Laboratory Science/Technology
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URN: urn:nbn:se:hb:diva-1215DOI: 10.1111/j.1600-0412.2011.01203.xLocal ID: 2320/10158OAI: oai:DiVA.org:hb-1215DiVA, id: diva2:869239
Available from: 2015-11-13 Created: 2015-11-13 Last updated: 2017-09-04Bibliographically approved

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Rosén, Karl Gustaf

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