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

NCT05606497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2022-11-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Stichting Achmea Gezondheidszor

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • J. Kooiman, MD, PhD, Epidemiologist · UMC Utrecht

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2023-09-01
Completion
2024-11-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606497 on ClinicalTrials.gov