Clinical trial NCT05606497: OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study
Official title: OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Retardation
Keywords: fetal growth restriction
retrospective cohort study
antenatal corticosteroids
dynamic predictive tool
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Stichting Achmea Gezondheidszor
First posted: 2022-11-04
Enrollment: 1800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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
timeFrame: From date of diagnosis of early-onset FGR up to hospital-discharge of the offspring, date of death of the offspring will be documented.
measure: The primary outcome measure for the dynamic predictive tool will be defined as 'days until delivery'.
timeFrame: 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:
measure: Mode of birth, assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of stillbirths, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to delivery this outcome measure will be documented.
measure: Gestational age at birth (in days), assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of preterm births, assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of extremely preterm births, assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Birthweight (in grams), assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of neonates with birthweight < 10th percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of neonates with birthweight < 3rd percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
timeFrame: This outcome measure will be documented by use of data from the day of birth.
measure: Number of neonates with need for mechanical ventilation, assessed by scrutinizing medical records.
timeFrame: From delivery up to hopsital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with bronchopulmonary dyspasia, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with necrotizing enterocolitis ≥ 2 according to the Bell's stages, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with neonatal seizures, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with hypoxic-ischemic encephalopathy, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonatal deaths, assessed by scrutinizing medical records.
timeFrame: From delivery up to 28 days after birth of the offspring this outcome measure will be documented.
measure: Number of in-hospital deaths, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with respiratory distress syndrome, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with intraventricular hemorrhage, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with cystic periventricular leukomalacia, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with retinopathy of prematurity, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with neonatal sepsis, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates diagnosed with persistent pulmonary hypertension of the newborn, assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Duration of supplemental oxygen therapy during admission of the offspring (in days), assessed by scrutinizing medical records.
timeFrame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
measure: Number of neonates with need for mechanical ventilation < 72 hours post-partum, assessed by scrutinizing medical records.
timeFrame: From delivery up to 72 hours after birth this outcome measure will be documented.
measure: Number of childs with cognitive impairment, assessed by scrutinizing medical records.
timeFrame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
measure: Number of childs with motor impairment, assessed by scrutinizing medical records.
timeFrame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
measure: Number of childs diagnosed with cerebral palsy, assessed by scrutinizing medical records.
timeFrame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
measure: Number of childs with hearing impairment, assessed by scrutinizing medical records.
timeFrame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
measure: Number of childs with visual impairment, assessed by scrutinizing medical records.
timeFrame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
measure: Number of maternal deaths, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of patients diagnosed with (pre-)eclampsia, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with a Glasgow Coma Score < 13, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with a stroke or reversible ischaemic neurological deficit, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with a transient ischaemic attack, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with cortical blindness or retinal detachment, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with posterior reversible encephalopathy, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with need for positive inotropic support, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with need for infusion of a third parenteral antihypertensive drug, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with myocardial ischaemia or infarction, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with oxygen saturation below 90%, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with ≥ 50% fraction of inspired oxygen for more than one hour, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with need for intubation, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with pulmonary oedema, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with need for transfusion of any blood product, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with a platelet count < 50x10^9 per liter with no transfusion, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with hepatic dysfunction, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with hepatic haematoma or rupture, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with acute renal insufficiency, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with acute renal failure, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers with need for renal dialysis, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with placental abruption, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with severe ascites, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
measure: Number of mothers diagnosed with Bell's palsy, assessed by scrutinizing medical records.
timeFrame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht, Wilhelmina Children's Hospital
Study officials:
affiliation: UMC Utrecht
name: J. Kooiman, MD, PhD, Epidemiologist
role: PRINCIPAL_INVESTIGATOR
References: