|- candidate number||1299|
|- NTR Number||NTR174|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||1-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The cost-effectiveness of ST-analysis of the fetal electrocardiogram as compared to fetal blood sampling for intrapartum monitoring: a randomised controlled trial.|
|- Scientific Title||The cost-effectiveness of ST-analysis of the fetal electrocardiogram as compared to fetal blood sampling for intrapartum monitoring: a randomised controlled trial.|
|- ACRONYM||STAN versus CTG + FBS|
|- hypothesis||Intrapartum fetal monitoring with the STAN-method (cardiotocograpy with ST-analysis of the fetal ECG) results in less neonates with metabolic acidosis and less interventions for fetal distress as compared to monitoring with cardiotocography in combination with fetal blood sampling.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Labour, Risc|
|- Inclusion criteria||Women in labour with a singleton fetus in vertex position and a gestational age > 35 + 6 weeks of gestation and an indication for electronic fetal monitoring (CTG).|
|- Exclusion criteria||1. Women with a fetus in breech position;|
2. Women with twin pregnancy;
3. No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-apr-2006|
|- planned closingdate||1-apr-2009|
|- Target number of participants||5100|
|- Interventions||Women will be randomly assigned to routine care including fetal monitoring by cardiotocography with fetal blood sampling (CTG + FBS group) or to the index group including cardiotocography with ST-analysis (CTG + ST group). Clinical management in the CTG + FBS group (routine care) will be guided by guidelines produced by the FIGO. FBS is recommended in case of a suboptimal or abnormal CTG pattern. In cases with scalp blood pH lower than 7.20 or preterminal cardiotocograms delivery is recommended. In the CTG + ST group, clinical management will be supported by computerised ST waveform assessment and will be guided by the STAN-guidelines, indicating when intervention is recommended.In case of poor signal quality of the fetal ECG-signal it is allowed to perform a FBS in the first stage of labour. From each woman, we will systematically (by protocol) document demographics and medical history, as well as CTG analysis, fetal ST-analyis and FBS results. Finally, the umbilical cord artery results, the performance of an instrumental delivery and neonatal outcome until discharge from the hospital will be documented.
CTG and FBS:
In women randomised to the control group, a scalp electrode will be applied to the fetal head and connected to the conventional CTG-monitor conform routine practice of CTG monitoring.
If the pH of the first measurement is below 7,20 delivery is recommended unless the cause of fetal distress can be alleviated. If the pH is between 7,20 and 7,25 FBS will be repeated after 30 minutes. If the pH is above 7,25 FBS is repeated according to CTG pattern according to the attending doctor or midwife.
The number of failed FBS will be recorded.
CTG and ST-analysis.
In women randomised to the index group, a scalp electrode will be applied to the fetal head and connected to the STAN-monitor conform routine practice of CTG monitoring. This electrode will allow both standard fetal heart rate monitoring (CTG) as well as ST-analysis. The CTG will be classified as normal, intermediate, abnormal or preterminal according to the FIGO-guidelines for fetal heart rate monitoring. The ST log automatically alerts the attending doctor or midwife if a significant ST-event occurs. Delivery is recommended when there are significant ST-changes (see appendix B) unless the cause of fetal distress can be alleviated.
It is only allowed to perform FBS in the CTG + ST-analysis arm in case of poor signal quality of the fetal ECG in combination with an intermediate or abnormal fetal heart rate pattern in the first stage.
|- Primary outcome||Presence or absence of metabolic acidosis defined as a pH < 7.05 and a BDecf > 12 mmol/l in the umbilical cord artery.|
|- Secondary outcome||1. Instrumental delivery rate for the following indications:|
fetal distress, failure to progress or a combination;
2. Cost-effectiveness of both strategies: see below;
3. Neonatal outcome defined by low Apgar scores, defined as < 4 after 1 minute and/or < 7 after 5 minutes;
4. Need for admission to the neonatal medium or intensive care unit;
5. Cost-effectiveness of both monitoring strategies across hospitals, particularly, comparing academic and non-academic hospitals.
|- Trial web site||http://www.studies-obsgyn.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. G.H.A. Visser|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A. Kwee|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:|
Cardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive results and without fetal blood sampling (FBS) it results in an increase in operative deliveries without an improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two RCTs have shown that a combination of CTG and non-invasive ST-analysis (of the fetal ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both RCTs FBS was still performed in both arms, 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.
To quantify costs and effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in order to judge whether the ST-analysis can replace FBS.
Multicentre randomised controlled trial in eight hospitals.
Women in labour (> 36 weeks of gestation) with an indication for CTG.
Women will be randomised for fetal surveillance with CTG + FBS or CTG + ST-analysis.
Primary outcome is the incidence of metabolic acidosis (defined as pH < 7.05 and BDecf > 12 mmol/l in the umbilical cord artery).
Secondary outcome measures are:
instrumental delivery rate, cost-effectiveness, neonatal outcome (Apgar score, admission to a neonatal ward) 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 beta of 0.80, in favour of CTG + ST-analysis, 5100 women have to be randomised (2550 per group).
The economic evaluation is designed as cost-effectiveness analysis, i.e. the ratio of (I) incremental costs and (II) the reduced rate of metabolic acidosis, associated with the strategies is quantified.
The total research period is 3 years: a start-up phase of 4 months, an inclusion period of 26 months and 6 months to realise follow-up, analysis and reporting.
|- Main changes (audit trail)|
|- RECORD||25-aug-2005 - 16-jul-2007|