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

NCT05606497 | Unknown DMC

• 1 other identifier: 22/613
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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

Keywords

fetal growth restriction; retrospective cohort study; antenatal corticosteroids; dynamic predictive tool

Outcome Measures

Primary Outcomes (2)

• The primary outcome for the comparison of timing strategies will be the number of perinatal, neonatal and in-hospital deaths in the offspring, assessed by scrutinizing medical records

  This data will be validated by use of the Dutch perinatal registration data (Perined)

  From date of diagnosis of early-onset FGR up to hospital-discharge of the offspring, date of death of the offspring will be documented.

• The primary outcome measure for the dynamic predictive tool will be defined as 'days until delivery'.

  Candidate predictors for the dynamic, predictive tool will be: estimated fetal weight, pulsatility index of the umbilical artery, pulsatility index of the cerebral middle artery, cerebroplacental ratio, pulsatility index of veins ductus venosus, absence of interval growth, repetitive decelerations on CTG, short-term variability, subjective fetal movements, presence of hypertensive disorders of pregnancy, use of anti-hypertensive drugs, use of magnesium sulphate, number of hypertensive crises, presence of lung edema, progression of organ dysfunction.

  From date of diagnosis of early-onset FGR up to delivery data regarding the candidate predictors, summarized under 'Description', will be documented on every day an ultrasound examination is performed.

Secondary Outcomes (52)

• Mode of birth, assessed by scrutinizing medical records.

  This outcome measure will be documented by use of data from the day of birth.

• Number of stillbirths, assessed by scrutinizing medical records.

  From diagnosis of early-onset FGR up to delivery this outcome measure will be documented.

• Gestational age at birth (in days), assessed by scrutinizing medical records.

  This outcome measure will be documented by use of data from the day of birth.

• Number of preterm births, assessed by scrutinizing medical records.

  This outcome measure will be documented by use of data from the day of birth.

• Number of extremely preterm births, assessed by scrutinizing medical records.

  This outcome measure will be documented by use of data from the day of birth.

Study Arms (1)

Early-onset FGR

Drug: Corticosteroid

Interventions

Corticosteroid 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.

Also known as: Antenatal corticosteroids, Betamethasone, Dexamethasone

Early-onset FGR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Singleton pregnancies complicated by early-onset FGR will be included in the study if they opt for active, neonatal management after counselling and are at least 18 years old.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Stichting Achmea Gezondheidszor: collaborator

Study Sites (1)

UMC Utrecht, Wilhelmina Children's Hospital

Utrecht, 3584 EA, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 36931680 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Adrenal Cortex Hormones; Betamethasone; Dexamethasone

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• J. Kooiman, MD, PhD, Epidemiologist

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Kooiman, MD, PhD

CONTACT

0031653942664; j.kooiman@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 4, 2022
• Study Start: May 11, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-10

Locations

NL (1)