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OpenTrials
Completed

NCT Number: NCT03862976

Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

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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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriele Saccone

Naples, 80129, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • IUGR

Treatment and study plan

computerized cardiotocography

Diagnostic Test

computerized cardiotocography (C-CTG)

Primary outcomes

  1. cesarean section

    Time frame: at the time of delivery

    incidence of cesarean section

Secondary outcomes

  1. gestational age at delivery

    Time frame: at the time of delivery

    week of delivery

  2. admission to neonatal intensive care unit

    Time frame: at the time of delivery

    admission to neonatal intensive care unit

  3. birth weight

    Time frame: at the time of delivery

    neonatal birth weight at delivery

  4. APGAR score at delivery

    Time frame: at the time of delivery

    APGAR score at delivery

  5. neonatal death

    Time frame: 28 days of live of the neonate

    death of a live neonates within 28 days of life

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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