Open AccessSwedish 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
Author(s) -
AMERWÅHLIN ISIS,
KJELLMER INGEMAR,
MARŠÁL KAREL,
OLOFSSON PER,
ROSÉN KARL GUSTAF
Publication year - 2011
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/j.1600-0412.2011.01203.x
Subject(s) - cardiotocography , medicine , umbilical artery , randomized controlled trial , metabolic acidosis , confidence interval , relative risk , acidosis , obstetrics , fetus , apgar score , pregnancy , genetics , biology
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 >12.0mmol/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.