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- Amer-Wåhlin, I, et al.
(author)
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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.
- 2011
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In: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons Ltd.. - 0001-6349 .- 1600-0412. ; 90:9, s. 990-996
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Journal article (peer-reviewed)abstract
- 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.
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- Kro, G A B, et al.
(author)
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A new tool for the validation of umbilical cord acid-base data.
- 2010
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In: BJOG : an international journal of obstetrics and gynaecology. - : Wiley. - 1471-0528 .- 1470-0328. ; 117:12, s. 1544-52
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Journal article (peer-reviewed)abstract
- To identify the distribution of carbon dioxide tension (pCO(2) ) relative to pH in validated umbilical cord acid-base data.
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3. |
- Kro, GA, et al.
(author)
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Association between umbilical cord artery pCO₂ and the Apgar score; elevated levels of pCO₂ may be beneficial for neonatal vitality after moderate acidemia.
- 2013
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In: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons Ltd.. - 0001-6349 .- 1600-0412. ; 92:6, s. 662-70
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To determine the association between 5-min Apgar score and umbilical cord artery carbon dioxide tension (pCO₂). DESIGN: Observational study. SETTING: European hospital labor wards. POPULATION: Data from 36,432 newborns ≥36 gestational weeks were obtained from three sources: two trials of monitoring with fetal electrocardiogram (the Swedish randomized controlled trial and the European Union Fetal ECG trial) and Mölndal Hospital data. After validation of the acid-base values, 25,806 5-min Apgar scores were available for analysis. METHODS: Validation of the umbilical cord acid-base values was performed to obtain reliable data. 5-min Apgar score was regressed against cord artery pCO₂ in a polynomial multilevel model. MAIN OUTCOME MEASURES: Five-min Apgar score, umbilical cord pCO₂, pH, and base deficit. RESULTS: Overall, a higher cord artery pCO₂ was found to be associated with lower 5-min Apgar scores. However, among newborns with moderate acidemia, lower umbilical cord artery pCO₂ (≤median pCO₂ for the specific cord artery pH) was associated with lower 5-min Apgar scores, with a relative risk of 2.0 (95% confidence interval: 1.4-2.8) for 5-min Apgar scores 0-6. CONCLUSIONS: Metabolic acidosis affects the newborn's vitality more than respiratory acidosis. In addition, elevated levels of pCO₂ may be beneficial for fetuses with moderate acidemia, and thus cord artery pCO₂ is a factor that should be considered when assessing the compromised newborn.
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