Implementation of new medical techniques: Experience from the Swedish randomized controlled trial on fetal ECG during labor

Background. In a large Swedish multicenter randomized controlled trial (RCT) on intra partum fetal monitoring with automatic analysis of fetal ECG waveform (STAN) in combination with cardiotocography (CTG) (4966 parturients, 300 obstetricians and midwives managing the patients), interim analysis revealed protocol violations. By a post hoc analysis of the results over time, factors affecting the acceptance of the new technique were analyzed. Methods. The rates of primary and secondary outcome measures (fetal outcome, operative deliveries) were compared in the two study groups (CTG + ST and CTG only). Changes over time were statistically evaluated using a test for homogeneity between the two periods. Results. After retraining, the CTG + ST group showed the lowest rates of operative delivery for fetal distress, fetal blood sampling and admissions to neonatal intensive care unit. Operative deliveries (p = 0.02) and the number of fetal blood sampling decreased significantly over time (p = 0.001). Conclusions. Training and education probably predisposed the clinicians to a change and reinforced it when it occurred as a result of increased personal experience. The audit and feedback together with the influence of opinion leaders and inter-collegial interactions seem to have been of importance for the successively increasing acceptance of the new method during the RCT.

[1]  K. Maršál,et al.  Fetal heart rate patterns and ECG ST segment changes preceding metabolic acidaemia at birth , 2005, BJOG : an international journal of obstetrics and gynaecology.

[2]  L. Bakketeig,et al.  RANDOMISED CONTROLLED TRIAL OF ULTRASONOGRAPHIC SCREENING IN PREGNANCY , 1984, The Lancet.

[3]  K. Maršál,et al.  Umbilical artery velocimetry may influence clinical interpretation of intrapartum cardiotocograms , 1995, Acta obstetricia et gynecologica Scandinavica.

[4]  M. Enkin.  A Guide to Effective Care in Pregnancy and Childbirth , 1989 .

[5]  G. Lingman,et al.  A critical appraisal of the use of umbilical artery Doppler ultrasound in high‐risk pregnancies: use of meta‐analyses in evidence‐based obstetrics , 2001, Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology.

[6]  R. Haynes,et al.  Evidence for the effectiveness of CME. A review of 50 randomized controlled trials. , 1992, JAMA.

[7]  M. Enkin,et al.  Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians. , 1989, The New England journal of medicine.

[8]  K. Maršál,et al.  Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial , 2001, The Lancet.

[9]  D B Swedlow,et al.  A multicenter controlled trial of fetal pulse oximetry in the intrapartum management of nonreassuring fetal heart rate patterns. , 2000, American journal of obstetrics and gynecology.

[10]  D. Spiegelhalter,et al.  A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. , 2003, BJOG : an international journal of obstetrics and gynaecology.

[11]  J. Westgate,et al.  Plymouth randomized trial of cardiotocogram only versus ST waveform plus cardiotocogram for intrapartum monitoring in 2400 cases. , 1993, American journal of obstetrics and gynecology.

[12]  K. Maršál,et al.  Fetal electrocardiography in labor and neonatal outcome: data from the Swedish randomized controlled trial on intrapartum fetal monitoring. , 2003, American journal of obstetrics and gynecology.

[13]  S. Thacker,et al.  Revisiting the use of the electronic fetal monitor , 2003, The Lancet.

[14]  S. Nutley,et al.  Developing learning organisations in the new NHS , 2000, BMJ : British Medical Journal.

[15]  S F Bottoms,et al.  The physician factor in cesarean birth rates. , 1989, The New England journal of medicine.

[16]  L. Keith,et al.  The Northwestern University Twin Study. VII: The mode of delivery in twin pregnancy. North American considerations. , 1988, Acta geneticae medicae et gemellologiae.

[17]  K. Rosen,et al.  ST analysis of the fetal electrocardiogram during labor: Nordic observational multicenter study , 2002, The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians.

[18]  Eugene Vayda,et al.  Opinion leaders vs audit and feedback to implement practice guidelines. Delivery after previous cesarean section. , 1991, JAMA.

[19]  P. R. Manning.  Changing and Learning in the Lives of Physicians , 1990 .

[20]  N Freemantle,et al.  EUR-ASSESS Project Subgroup Report on Dissemination and Impact , 1997, International Journal of Technology Assessment in Health Care.