Clinical Trial: Cadiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Cardiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH in Deliveries With Abnormal CTG - A Randomised Trial

Brief Summary:

Hypothesis:

STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis.

Primary endpoint:

1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10.

Secondary endpoints:

  1. Number of intervention (VE and caesarean section) in the two groups
  2. Number of pH measurements in the two groups
  3. Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups

The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs.

CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analys

Detailed Summary:

The value of STAN (ST analysis) was assessed in 2 randomized trials and shows: 1) A reduction in the incidence of severe hypoxia in fetuses during labor and 2) A reduction in frequency of redemption with suction and caesarean section due to lack of oxygen during the birth process.

Within the last year however, there is substantial new information regarding. STAN. The Swedish Social Board has published a newsletter (17) which describes a possible risk of birth of asphyxiated children, some died and others have cerebral palsy. A new Finnish study (18) suggests that there may be an increased risk of (moderate) acidosis after using STAN.

The above has led to considerable debate, not just in Sweden but also throughout Europe. This has led to the Swedish, Danish (Newsletter 1, Annex 1b) and the common Nordic reference group for STAN orally has announced new clinical guidelines for STAN application. A recently held workshop in Utrecht, Holland will generate joint European guideline, these will be sought published. Against this background it has been necessary to develop new guidelines for the complement of scalp pH in the STAN arm of this project (Annex 1a)

Common to the above studies is that there is consistently applied scalp pH before STAN monitoring begins. It is therefore important to elucidate whether, through the use of STAN monitoring is needed (more than 1) FBS - and if so to what extent FBS is required.

STAN method currently winning widespread in Denmark and internationally (FDA has just approved), notwithstanding that it is not scientifically proven that fetal monitoring with STAN is better than the current monitoring method with scalp pH measurement. It is therefore important to get this resolved in a randomized study i
Sponsor: Hvidovre University Hospital

Current Primary Outcome: Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery [ Time Frame: within 1 hour ]

We will do a minimum 2 year follow-up on the children


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Does STAN reduce number of admissions to NICU and/or HIE [ Time Frame: 2 years after termination of study ]
    Number of neonates admitted to NICU because of suspected asphyxia in the two groups. There will also be a minimun of 2 years of follow-up in these children
  • Does STAN reduce number of interventions in delivery(vacuum or section) [ Time Frame: 1 year after termination of study ]


Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: January 10, 2012
Date Started: December 2005
Date Completion: December 2012
Last Updated: October 3, 2012
Last Verified: October 2012