Cadiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH
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|ClinicalTrials.gov Identifier: NCT01699646|
Recruitment Status : Terminated (slow enrollment)
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis.
1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10.
- Number of intervention (VE and caesarean section) in the two groups
- Number of pH measurements in the two groups
- 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 analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.
The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Acidosis of Newborn||Device: Neoventa S 21 ST-ANalysis of fetal heart Procedure: CTG + FBS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1025 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH in Deliveries With Abnormal CTG - A Randomised Trial|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||December 2012|
Active Comparator: CTG + FBS
intrapartum surveillance with CTG+FBS
Procedure: CTG + FBS
Cardiotocography and fetal blood sampling on/from fetal skalp
Other Name: Cardiotocography and fetal blood sampling (scalp-pH)
Active Comparator: Neoventa S 21 ST-ANalysis of fetal heart
intrapartum surveillance with CTG + STAN
Device: Neoventa S 21 ST-ANalysis of fetal heart
Application of "gold-trace" scalp electrode
Other Name: Cardiotocography and ST-ANalysis
- 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
- 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 ]
- Does ST-ANalysis increase specificity and sensitivity of scalp-pH and vise verce [ Time Frame: 1 year after termination of study ]
- Does STAN reduce number of scalp-pH measurements [ Time Frame: 1 year after termination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699646
|Copenhagen, Hvidovre, Denmark, 2650|
|Study Director:||Niels J Secher, prof, MD||Copenhagen University, Denmark|