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

NCT ID: NCT05606497

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2024-11-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Early-onset FGR

Corticosteroid

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Antenatal corticosteroids; Betamethasone; Dexamethasone

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stichting Achmea Gezondheidszor

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Dr. Judith Kooiman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Kooiman, MD, PhD, Epidemiologist

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

UMC Utrecht, Wilhelmina Children's Hospital

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

J. Kooiman, MD, PhD

Role: CONTACT

j.kooiman@umcutrecht.nl

0031653942664

Facility Contacts

M. van de Meent, MD, PhD Candidate

Role: primary

m.vandemeent@umcutrecht.nl

0031611714404

References

van de Meent M, Kleuskens DG, Ganzevoort W, Gordijn SJ, Kooi EMW, Onland W, van Rijn BB, Duvekot JJ, Kornelisse RF, Al-Nasiry S, Jellema RK, Knol HM, Manten GTR, Mulder-de Tollenaer SM, Derks JB, Groenendaal F, Bekker MN, Schuit E, Lely AT, Kooiman J. OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE): study protocol of a multicentre, retrospective cohort study. BMJ Open. 2023 Mar 17;13(3):e070729. doi: 10.1136/bmjopen-2022-070729.

Reference Type: DERIVED

PMID: 36931680 (View on PubMed)

Other Identifiers

22/613

Identifier Type: -

Identifier Source: org_study_id