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Shaun P. Brennecke - One of the best experts on this subject based on the ideXlab platform.
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Protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour: the Flamingo trial [ACTRN12611000172909]
BMC Pregnancy and Childbirth, 2015Co-Authors: Christine E. East, Stefan C. Kane, Mary-ann Davey, C. Omar Kamlin, Shaun P. BrenneckeAbstract:Background The rate of caesarean sections around the world is rising each year, reaching epidemic proportions. Although many caesarean sections are performed for concerns about fetal welfare on the basis of abnormal Cardiotocography, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short and long term risks, could have been avoided without compromising the baby’s health. Previously, fetal scalp blood sampling for pH estimation was performed in the context of an abnormal cardiotocograph, to improve the identification of babies in need of expedited delivery. This test has largely been replaced by lactate measurement, although its validity is yet to be established through a randomised controlled trial. This study aims to test the hypothesis that the performance of fetal scalp blood lactate measurement for women in labour with an abnormal cardiotocograph will reduce the rate of birth by caesarean section from 38 % to 25 % (a 35 % relative reduction). Methods/Design Prospective unblinded randomised controlled trial conducted at a single tertiary perinatal centre. Women labouring with a singleton fetus in cephalic presentation at 37 or more weeks’ gestation with ruptured membranes and with an abnormal cardiotocograph will be eligible. Participants will be randomised to one of two groups: fetal monitoring by Cardiotocography alone, or Cardiotocography augmented by fetal scalp blood lactate analysis. Decisions regarding the timing and mode of delivery will be made by the treating team, in accordance with hospital protocols. The primary study endpoint is caesarean section with secondary outcomes collected from maternal, fetal and neonatal clinical course and morbidities. A cost effectiveness analysis will also be performed. A sample size of 600 will provide 90 % power to detect the hypothesised difference in the proportion of women who give birth by caesarean section. Discussion This world-first trial is adequately powered to determine the impact of fetal scalp blood lactate measurement on rates of caesarean section. Preventing unnecessary caesarean sections will reduce the health and financial burdens associated with this operation, both in the index and any future pregnancies. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000172909
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protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour the flamingo trial actrn12611000172909
BMC Pregnancy and Childbirth, 2015Co-Authors: Christine East, Stefan C. Kane, Mary-ann Davey, Omar C F Kamlin, Shaun P. BrenneckeAbstract:The rate of caesarean sections around the world is rising each year, reaching epidemic proportions. Although many caesarean sections are performed for concerns about fetal welfare on the basis of abnormal Cardiotocography, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short and long term risks, could have been avoided without compromising the baby’s health. Previously, fetal scalp blood sampling for pH estimation was performed in the context of an abnormal cardiotocograph, to improve the identification of babies in need of expedited delivery. This test has largely been replaced by lactate measurement, although its validity is yet to be established through a randomised controlled trial. This study aims to test the hypothesis that the performance of fetal scalp blood lactate measurement for women in labour with an abnormal cardiotocograph will reduce the rate of birth by caesarean section from 38 % to 25 % (a 35 % relative reduction).
Isis Amerwahlin - One of the best experts on this subject based on the ideXlab platform.
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fetal electrocardiography st segment analysis for intrapartum monitoring a critical appraisal of conflicting evidence and a way forward
American Journal of Obstetrics and Gynecology, 2019Co-Authors: Isis Amerwahlin, Susanna Timonen, Anneke Kwee, Austin Ugwumadu, Branka M Yli, Vanessa Cole, Diogo Ayresdecampos, Georgesemmanuel Roth, Christiane Schwarz, Luca A RamenghiAbstract:Background In the past century, some areas of obstetric including intrapartum care have been slow to benefit from the dramatic advances in technology and medical care. Although fetal heart rate monitoring (Cardiotocography) became available a half century ago, its interpretation often differs between institutions and countries, its diagnostic accuracy needs improvement, and a technology to help reduce the unnecessary obstetric interventions that have accompanied the Cardiotocography is urgently needed. Study Design During the second half of the 20th century, key findings in animal experiments captured the close relationship between myocardial glycogenolysis, myocardial workload, and ST changes, thus demonstrating that ST waveform analysis of the fetal electrocardiogram can provide information on oxygenation of the fetal myocardium and establishing the physiological basis for the use of electrocardiogram in intrapartum fetal surveillance. Results Six randomized controlled trials, 10 meta-analyses, and more than 20 observational studies have evaluated the technology developed based on this principle. Nonetheless, despite this intensive assessment, differences in study protocols, inclusion criteria, enrollment rates, clinical guidelines, use of fetal blood sampling, and definitions of key outcome parameters, as well as inconsistencies in randomized controlled trial data handling and statistical methodology, have made this voluminous evidence difficult to interpret. Enormous resources spent on randomized controlled trials have failed to guarantee the generalizability of their results to other settings or their ability to reflect everyday clinical practice. Conclusion The latest meta-analysis used revised data from primary randomized controlled trials and data from the largest randomized controlled trials from the United States to demonstrate a significant reduction of metabolic acidosis rates by 36% (odds ratio, 0.64; 95% confidence interval, 0.46–0.88) and operative vaginal delivery rates by 8% (relative risk, 0.92; 95% confidence interval, 0.86–0.99), compared with Cardiotocography alone.
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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
Acta Obstetricia et Gynecologica Scandinavica, 2011Co-Authors: Isis Amerwahlin, Karel Marsal, Ingemar Kjellmer, Per Olofsson, K G RosenAbstract: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 ...
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fetal electrocardiogram st waveform analysis in intrapartum surveillance
British Journal of Obstetrics and Gynaecology, 2007Co-Authors: Isis Amerwahlin, Karel Marsal, Henrik Hagberg, Sabaratnam Arulkumaran, Gerard H A VisserAbstract:ST waveform analysis of fetal electrocardiogram (ECG) for intrapartum surveillance (STAN) is a newly introduced method for fetal surveillance. The purpose of this commentary is to assist in the proper use of fetal ECG in combination with Cardiotocography (CTG) during labour. Guidelines and recommendations concerning CTG and ST waveform interpretation and classification are stated that were agreed on by the European experts on ST waveform analysis for intrapartum surveillance during a meeting in Utretcht, the Netherlands in January 2007.
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fetal electrocardiography in labor and neonatal outcome data from the swedish randomized controlled trial on intrapartum fetal monitoring
American Journal of Obstetrics and Gynecology, 2003Co-Authors: Hakan Noren, Isis Amerwahlin, Karel Marsal, Henrik Hagberg, Andreas Herbst, Ingemar Kjellmer, Per Olofsson, K G RosenAbstract:OBJECTIVE: Cardiotocography plus automatic ST analysis of the fetal electrocardiography has been shown recently to reduce both the operative delivery rate for fetal distress and the cord artery metabolic acidosis rate. The purpose of this study was to analyze findings that were related to cases with a complicated/adverse neonatal outcome in the Swedish randomized controlled trial. STUDY DESIGN: Of the 4966 term fetuses that were included in the trial, all 351 newborn infants who required special neonatal care were identified. Cases of perinatal death, neonatal encephalopathy, or metabolic acidosis at birth were reviewed. RESULTS: Of the 29 fetuses with adverse/complicated neonatal outcome, 22 fetuses had Cardiotocography and ST patterns that indicated a need for intervention, according to the Cardiotocography plus ST clinical guidelines. The number of live-born with moderate or severe neonatal encephalopathy showed a significant decrease from 0.33% (8/2447 fetuses) in the Cardiotocography-only group to 0.04% (1/2519 fetuses) in the Cardiotocography plus ST group. CONCLUSION: Cardiotocography plus ST analysis provides accurate information about intrapartum hypoxia and may prevent intrapartum asphyxia and neonatal encephalopathy by giving a clear alert to the staff members who are in charge.
Per Olofsson - One of the best experts on this subject based on the ideXlab platform.
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a critical appraisal of the evidence for using Cardiotocography plus ecg st interval analysis for fetal surveillance in labor part ii the meta analyses
Acta Obstetricia et Gynecologica Scandinavica, 2014Co-Authors: Per Olofsson, Branka M Yli, Diogo Ayresdecampos, Jorg Kessler, Britta Tendal, Lawrence D DevoeAbstract:We appraised the methodology, execution and quality of the five published meta-analyses that are based on the five randomized controlled trials which compared Cardiotocography (CTG)+ST analysis to Cardiotocography. The meta-analyses contained errors, either created de novo in handling of original data or from a failure to recognize essential differences among the randomized controlled trials, particularly in their inclusion criteria and outcome parameters. No meta-analysis contained complete and relevant data from all five randomized controlled trials. We believe that one randomized controlled trial excluded in two of the meta-analyses should have been included, whereas one randomized controlled trial that was included in all meta-analyses, should have been excluded. After correction of the uncovered errors and exclusion of the randomized controlled trial that we deemed inappropriate, our new meta-analysis showed that CTG+ST monitoring significantly reduces the fetal scalp blood sampling usage (risk ratio 0.64; 95% confidence interval 0.47–0.88), total operative delivery rate (0.93; 0.88–0.99) and metabolic acidosis rate (0.61; 0.41–0.91).
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a critical appraisal of the evidence for using Cardiotocography plus ecg st interval analysis for fetal surveillance in labor part i the randomized controlled trials
Acta Obstetricia et Gynecologica Scandinavica, 2014Co-Authors: Per Olofsson, Branka M Yli, Diogo Ayresdecampos, Jorg Kessler, Britta Tendal, Lawrence D DevoeAbstract:We reappraised the five randomized controlled trials that compared Cardiotocography plus ECG ST interval analysis (CTG+ST) vs. Cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis.
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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
Acta Obstetricia et Gynecologica Scandinavica, 2011Co-Authors: Isis Amerwahlin, Karel Marsal, Ingemar Kjellmer, Per Olofsson, K G RosenAbstract: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 ...
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fetal electrocardiography in labor and neonatal outcome data from the swedish randomized controlled trial on intrapartum fetal monitoring
American Journal of Obstetrics and Gynecology, 2003Co-Authors: Hakan Noren, Isis Amerwahlin, Karel Marsal, Henrik Hagberg, Andreas Herbst, Ingemar Kjellmer, Per Olofsson, K G RosenAbstract:OBJECTIVE: Cardiotocography plus automatic ST analysis of the fetal electrocardiography has been shown recently to reduce both the operative delivery rate for fetal distress and the cord artery metabolic acidosis rate. The purpose of this study was to analyze findings that were related to cases with a complicated/adverse neonatal outcome in the Swedish randomized controlled trial. STUDY DESIGN: Of the 4966 term fetuses that were included in the trial, all 351 newborn infants who required special neonatal care were identified. Cases of perinatal death, neonatal encephalopathy, or metabolic acidosis at birth were reviewed. RESULTS: Of the 29 fetuses with adverse/complicated neonatal outcome, 22 fetuses had Cardiotocography and ST patterns that indicated a need for intervention, according to the Cardiotocography plus ST clinical guidelines. The number of live-born with moderate or severe neonatal encephalopathy showed a significant decrease from 0.33% (8/2447 fetuses) in the Cardiotocography-only group to 0.04% (1/2519 fetuses) in the Cardiotocography plus ST group. CONCLUSION: Cardiotocography plus ST analysis provides accurate information about intrapartum hypoxia and may prevent intrapartum asphyxia and neonatal encephalopathy by giving a clear alert to the staff members who are in charge.
Lawrence D Devoe - One of the best experts on this subject based on the ideXlab platform.
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a critical appraisal of the evidence for using Cardiotocography plus ecg st interval analysis for fetal surveillance in labor part ii the meta analyses
Acta Obstetricia et Gynecologica Scandinavica, 2014Co-Authors: Per Olofsson, Branka M Yli, Diogo Ayresdecampos, Jorg Kessler, Britta Tendal, Lawrence D DevoeAbstract:We appraised the methodology, execution and quality of the five published meta-analyses that are based on the five randomized controlled trials which compared Cardiotocography (CTG)+ST analysis to Cardiotocography. The meta-analyses contained errors, either created de novo in handling of original data or from a failure to recognize essential differences among the randomized controlled trials, particularly in their inclusion criteria and outcome parameters. No meta-analysis contained complete and relevant data from all five randomized controlled trials. We believe that one randomized controlled trial excluded in two of the meta-analyses should have been included, whereas one randomized controlled trial that was included in all meta-analyses, should have been excluded. After correction of the uncovered errors and exclusion of the randomized controlled trial that we deemed inappropriate, our new meta-analysis showed that CTG+ST monitoring significantly reduces the fetal scalp blood sampling usage (risk ratio 0.64; 95% confidence interval 0.47–0.88), total operative delivery rate (0.93; 0.88–0.99) and metabolic acidosis rate (0.61; 0.41–0.91).
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a critical appraisal of the evidence for using Cardiotocography plus ecg st interval analysis for fetal surveillance in labor part i the randomized controlled trials
Acta Obstetricia et Gynecologica Scandinavica, 2014Co-Authors: Per Olofsson, Branka M Yli, Diogo Ayresdecampos, Jorg Kessler, Britta Tendal, Lawrence D DevoeAbstract:We reappraised the five randomized controlled trials that compared Cardiotocography plus ECG ST interval analysis (CTG+ST) vs. Cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis.
Mary-ann Davey - One of the best experts on this subject based on the ideXlab platform.
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Protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour: the Flamingo trial [ACTRN12611000172909]
BMC Pregnancy and Childbirth, 2015Co-Authors: Christine E. East, Stefan C. Kane, Mary-ann Davey, C. Omar Kamlin, Shaun P. BrenneckeAbstract:Background The rate of caesarean sections around the world is rising each year, reaching epidemic proportions. Although many caesarean sections are performed for concerns about fetal welfare on the basis of abnormal Cardiotocography, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short and long term risks, could have been avoided without compromising the baby’s health. Previously, fetal scalp blood sampling for pH estimation was performed in the context of an abnormal cardiotocograph, to improve the identification of babies in need of expedited delivery. This test has largely been replaced by lactate measurement, although its validity is yet to be established through a randomised controlled trial. This study aims to test the hypothesis that the performance of fetal scalp blood lactate measurement for women in labour with an abnormal cardiotocograph will reduce the rate of birth by caesarean section from 38 % to 25 % (a 35 % relative reduction). Methods/Design Prospective unblinded randomised controlled trial conducted at a single tertiary perinatal centre. Women labouring with a singleton fetus in cephalic presentation at 37 or more weeks’ gestation with ruptured membranes and with an abnormal cardiotocograph will be eligible. Participants will be randomised to one of two groups: fetal monitoring by Cardiotocography alone, or Cardiotocography augmented by fetal scalp blood lactate analysis. Decisions regarding the timing and mode of delivery will be made by the treating team, in accordance with hospital protocols. The primary study endpoint is caesarean section with secondary outcomes collected from maternal, fetal and neonatal clinical course and morbidities. A cost effectiveness analysis will also be performed. A sample size of 600 will provide 90 % power to detect the hypothesised difference in the proportion of women who give birth by caesarean section. Discussion This world-first trial is adequately powered to determine the impact of fetal scalp blood lactate measurement on rates of caesarean section. Preventing unnecessary caesarean sections will reduce the health and financial burdens associated with this operation, both in the index and any future pregnancies. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000172909
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protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour the flamingo trial actrn12611000172909
BMC Pregnancy and Childbirth, 2015Co-Authors: Christine East, Stefan C. Kane, Mary-ann Davey, Omar C F Kamlin, Shaun P. BrenneckeAbstract:The rate of caesarean sections around the world is rising each year, reaching epidemic proportions. Although many caesarean sections are performed for concerns about fetal welfare on the basis of abnormal Cardiotocography, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short and long term risks, could have been avoided without compromising the baby’s health. Previously, fetal scalp blood sampling for pH estimation was performed in the context of an abnormal cardiotocograph, to improve the identification of babies in need of expedited delivery. This test has largely been replaced by lactate measurement, although its validity is yet to be established through a randomised controlled trial. This study aims to test the hypothesis that the performance of fetal scalp blood lactate measurement for women in labour with an abnormal cardiotocograph will reduce the rate of birth by caesarean section from 38 % to 25 % (a 35 % relative reduction).