STV Analysis Versus Visual Evaluation of Cardiotocography in FGR

NCT06010238 | Not Yet Recruiting DMC

• 1 other identifier: 84591
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.

Conditions

Fetal Growth Retardation

Keywords

fetal growth restriction; cardiotocography; perinatal death; short term variation

Outcome Measures

Primary Outcomes (1)

• Proportion of pregnancies resulting in perinatal death

  Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU

  Before discharge from neonatal intensive care unit (NICU), up to 1 year

Secondary Outcomes (3)

• Proportion of children with major neonatal morbidity

  Before discharge from NICU, up to 1 year

• Proportion of children with neonatal morbidities

  Before discharge from NICU, up to 1 year

• Proportion of children with neurodevelopmental impairment

  At two years of corrected age

Study Arms (2)

Visual interpretation of cardiotocography

ACTIVE COMPARATOR

Monitoring by visual interpretation of cardiotocography

Device: Visual interpretation

Short term variation

EXPERIMENTAL

Short term variation by computer software analysis

Device: Short term variation

Interventions

Short term variation DEVICE

Short term variation in computer software analysis

Short term variation

Visual interpretation DEVICE

Visual interpretation of cardiotocography

Visual interpretation of cardiotocography

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
• Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (\<p3) OR a combination of EFW \<p10 AND uterine artery pulsatility index (PI) \>p95 OR umbilical artery Doppler PI \>p95.
• Maternal age ≥ 18 years.
• Able to provide written informed consent for collection and use of data on informed consent form in available language.

You may not qualify if:

• Known congenital or chromosomal anomalies influencing perinatal outcome.
• Imminent labour or expected maternal indication for delivery \< 48 hours.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Fetal Growth Retardation; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death

Study Officials

• Wessel Ganzevoort, MD PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wessel Ganzevoort, MD PhD

CONTACT

003120-5669111; j.w.ganzevoort@amsterdamumc.nl

Anouk Pels, MD PhD

CONTACT

003120-5669111; a.pels@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Stepped wedge cluster randomized clinical trial

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 24, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share