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

UMC Utrecht

Status: Enrolling

Conditions: Fetal Growth Retardation

Treatments: Drug: Corticosteroid

Study type: Observational

Funder types: Other

Identifiers

NCT05606497

22/613

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,800 participants in 1 patient group

Early-onset FGR

Treatment:

Drug: Corticosteroid