Gabriele Saccone
Naples, 80129, Italy
NCT Number: NCT03862976
Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation.
Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate.
Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Naples, 80129, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
computerized cardiotocography (C-CTG)
Time frame: at the time of delivery
incidence of cesarean section
Time frame: at the time of delivery
week of delivery
Time frame: at the time of delivery
admission to neonatal intensive care unit
Time frame: at the time of delivery
neonatal birth weight at delivery
Time frame: at the time of delivery
APGAR score at delivery
Time frame: 28 days of live of the neonate
death of a live neonates within 28 days of life
Federico II University
Other
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