A randomised clinical trial on cardiotocography plus fetal blood sampling versus cardiotocography plus ST-analysis of the fetal electrocardiogram (STAN?) for intrapartum monitoring

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• 作者：Michelle EMH Westerhuis (1)
  Karel GM Moons (2)
  Erik van Beek (3)
  Saskia M Bijvoet (4)
  Addy P Drogtrop (5)
  Herman P van Geijn (4)
  Jan MM van Lith (6)
  Ben WJ Mol (7) (8)
  Jan G Nijhuis (9)
  Guid S Oei (8)
  Martina M Porath (8)
  Robbert JP Rijnders (10)
  Nico WE Schuitemaker (11)
  Ingeborg van der Tweel (12)
  Gerard HA Visser (1)
  Christine Willekes (9)
  Anneke Kwee (1)
  
• 刊名：BMC Pregnancy and Childbirth
• 出版年：2007
• 出版时间：December 2007
• 年：2007
• 卷：7
• 期：1
• 全文大小：864KB
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  16. Ojala K, Vaarasmaki M, Makikallio K, Valkama M, Tekay A: A comparison of intrapartum automated fetal electrocardiography and conventional cardiotocography--a randomised controlled study1. / BJOG 2006, 113:419-23. CrossRef
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  33. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/7/13/prepub
  
• 作者单位：Michelle EMH Westerhuis (1)
  Karel GM Moons (2)
  Erik van Beek (3)
  Saskia M Bijvoet (4)
  Addy P Drogtrop (5)
  Herman P van Geijn (4)
  Jan MM van Lith (6)
  Ben WJ Mol (7) (8)
  Jan G Nijhuis (9)
  Guid S Oei (8)
  Martina M Porath (8)
  Robbert JP Rijnders (10)
  Nico WE Schuitemaker (11)
  Ingeborg van der Tweel (12)
  Gerard HA Visser (1)
  Christine Willekes (9)
  Anneke Kwee (1)
  
  1. Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands
  2. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
  3. Department of Obstetrics and Gynaecology, Sint Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands
  4. Department of Obstetrics and Gynaecology, VU Medical Center Amsterdam, Amsterdam, The Netherlands
  5. Department of Obstetrics and Gynaecology, Tweesteden Hospital Tilburg, Tilburg, The Netherlands
  6. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwen Gasthuis Amsterdam, Amsterdam, The Netherlands
  7. Department of Obstetrics and Gynaecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands
  8. Department of Obstetrics and Gynaecology, Maxima Medical Center Veldhoven, Veldhoven, The Netherlands
  9. Department of Obstetrics and Gynaecology, Academic Medical Center Maastricht, Maastricht, The Netherlands
  10. Department of Obstetrics and Gynaecology, Jeroen Bosch Medical Center 's Hertogenbosch, Hertogenbosch, The Netherlands
  11. Department of Obstetrics and Gynaecology, Diakonessenhuis Utrecht, Utrecht, The Netherlands
  12. Center for Biostatistics, Utrecht University, Utrecht, The Netherlands
  

文摘

Background Cardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis. Methods/Design We aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options. Women in labour with a gestational age ?36 weeks and an indication for CTG-monitoring can be included in the trial. Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG. The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals. The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied. Discussion This study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed. Trial Registration Number ISRCTN95732366