Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

October 7, 2020 updated by: Gabriele Saccone, Federico II University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80129
        • Gabriele Saccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

- IUGR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: computerized cardiotocography
Diagnostic test: computerized cardiotocography
computerized cardiotocography (C-CTG)
ACTIVE_COMPARATOR: standard cardiotocography
standard cardiotocography non stresstest
Diagnostic test: computerized cardiotocography
computerized cardiotocography (C-CTG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cesarean section
Time Frame: at the time of delivery
incidence of cesarean section
at the time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestational age at delivery
Time Frame: at the time of delivery
week of delivery
at the time of delivery
admission to neonatal intensive care unit
Time Frame: at the time of delivery
admission to neonatal intensive care unit
at the time of delivery
birth weight
Time Frame: at the time of delivery
neonatal birth weight at delivery
at the time of delivery
APGAR score at delivery
Time Frame: at the time of delivery
APGAR score at delivery
at the time of delivery
neonatal death
Time Frame: 28 days of live of the neonate
death of a live neonates within 28 days of life
28 days of live of the neonate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2019

Primary Completion (ACTUAL)

December 15, 2019

Study Completion (ACTUAL)

March 23, 2020

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (ACTUAL)

March 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 371/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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