Skip to main content
Clinical Trials/NCT03862976
NCT03862976
Completed
Not Applicable

Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Federico II University1 site in 1 country28 target enrollmentMarch 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Federico II University
Enrollment
28
Locations
1
Primary Endpoint
cesarean section
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 25, 2019
End Date
March 23, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gabriele Saccone

doctor

Federico II University

Eligibility Criteria

Inclusion Criteria

  • Women with singleton gestation
  • 18 years to 50 years
  • High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

cesarean section

Time Frame: at the time of delivery

incidence of cesarean section

Secondary Outcomes

  • birth weight(at the time of delivery)
  • neonatal death(28 days of live of the neonate)
  • gestational age at delivery(at the time of delivery)
  • admission to neonatal intensive care unit(at the time of delivery)
  • APGAR score at delivery(at the time of delivery)

Study Sites (1)

Loading locations...

Similar Trials