NCT05606497

OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Growth Retardation

Interventions

Type	Name	Description
DRUG	Corticosteroid	Antenatal corticosteroids are administered to pregnancies at risk for preterm birth in order to reduce risks of neonatal morbidity and mortality following preterm birth.

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-09-01
• Completion: 2024-11-01
• First posted: 2022-11-04
• Last updated: 2022-11-04

Locations

1 site across 1 country: Netherlands