NCT03862976

Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	computerized cardiotocography	computerized cardiotocography (C-CTG)

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-12-15
• Completion: 2020-03-23
• First posted: 2019-03-05
• Last updated: 2020-10-08

Locations

1 site across 1 country: Italy