Status:
NOT_YET_RECRUITING
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Fetal Growth Retardation
Eligibility:
FEMALE
18-99 years
Phase:
NA
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 ...
Detailed Description
Severe, early-onset fetal growth restriction (FGR, \<32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency\[. This condition affects ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Known congenital or chromosomal anomalies influencing perinatal outcome.
- Imminent labour or expected maternal indication for delivery \< 48 hours.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06010238
Start Date
January 1 2025
End Date
January 1 2029
Last Update
August 9 2024
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