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Recruiting
NCT05606497
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study
Conditions: Fetal Growth Retardation
Sex: Female
Ages: 18 Years – N/A
Enrollment: 1800
Sponsor: UMC Utrecht
Location: Netherlands
Summary
The aim of this observational study is to optimize the timing of antenatal corticosteroids administered to patients with pregnancies complicated by early-onset fetal growth restriction in order to reduce neonatal morbidity and mortality.
In the Netherlands two main timing strategies of antenatal corticosteroids are commonly practiced.
In this study the investigators will compare these two timing strategies regarding CCS administration in early-onset FGR on the combined endpoint of perinatal, neonatal and in-hospital mortality.
In addition, the investigators aim to develop a dynamic, prediction tool, a novel technique in prediction research to predict the time-interval in days until delivery within this population.
With that, the investigators aim to reduce neonatal morbidity and mortality for future FGR pregnancies.
Eligibility Criteria
Inclusion Criteria:Early-onset FGR in accordance with the consensus-based definition of Gordijn et al. (19);Singleton pregnancy;Age ≥ 18 years;Installed active, neonatal management after counselling (thus having an indication for CCS administration in case of birth < 34 weeks of gestational age).Exclusion Criteria:Multiple pregnancies;Fetal congenital abnormalities or antenatal diagnosed genetic disorders;Patients who stated that their patient or offspring data may not be used for scientific research.
Source: ClinicalTrials.gov (NCT05606497). StuddyBuddy aggregates publicly available trial information.