Fetal Growth RetardationOPTICORENCT05606497
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study
An observational study of Fetal Growth Retardation, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Corticosteroid
- How many people
- 1,800 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 May 2022to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht, Wilhelmina Children's Hospital
Utrecht, 3584 EA
M. van de Meent, MD, PhD Candidate, 0031611714404, m.vandemeent@umcutrecht.nl
About this study
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
- Being tested
- Corticosteroid
- Keywords
- fetal growth restriction, retrospective cohort study, antenatal corticosteroids, dynamic predictive tool
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Antenatal corticosteroids, Betamethasone, Dexamethasone
Antenatal corticosteroids are administered to pregnancies at risk for preterm birth in order to reduce risks of neonatal morbidity and mortality following preterm birth.
| Study group | Role | What they receive |
|---|---|---|
| Early-onset FGR | Not described Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Mode of birth defined as vaginal or caesarian section.
Measured: This outcome measure will be documented by use of data from the day of birth.
Number of stillbirths, assessed by scrutinizing medical records.
Stillbirth is defined as death of fetus ante- or intrapartum
Measured: 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.
Gestational age will be recorded in weeks as well.
Measured: This outcome measure will be documented by use of data from the day of birth.
Number of preterm births, assessed by scrutinizing medical records.
Preterm birth defined as delivery before 37.0 weeks of gestational age.
Measured: 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.
Extremely preterm birth is defined as delivery before 28 weeks of gestational age.
Measured: This outcome measure will be documented by use of data from the day of birth.
Birthweight (in grams), assessed by scrutinizing medical records.
Birthweight defined as weight at time of birth (in grams)
Measured: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with birthweight < 10th percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
Measured: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with birthweight < 3rd percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
Measured: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with need for mechanical ventilation, assessed by scrutinizing medical records.
Mechanical ventilation defined as need for intubation and mechanical ventilation to support gas exchange
Measured: From delivery up to hopsital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with bronchopulmonary dyspasia, assessed by scrutinizing medical records.
Bronchopulmonary dysplasia is diagnosed if gestational age <32 weeks: at a postmenstrual age of 36 weeks, >21% oxygen has been administered cumulatively for 28 or more days
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with necrotizing enterocolitis ≥ 2 according to the Bell's stages, assessed by scrutinizing medical records.
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with neonatal seizures, assessed by scrutinizing medical records.
Neonatal seizures defined as transient electrographic change in the brain due to an abnormal, excessive or synchronous neuronal activity either with the occurrence of clinical signs (electro-clinical) or without them (electrographic only) in preterm infants
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with hypoxic-ischemic encephalopathy, assessed by scrutinizing medical records.
Hypoxic-ischemic encephalopathy defined as a clinical syndrome that results from a severe or prolonged hypoxic-ischemic episode before or during birth
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonatal deaths, assessed by scrutinizing medical records.
Death of the neonate within 28 days after birth
Measured: From delivery up to 28 days after birth of the offspring this outcome measure will be documented.
Number of in-hospital deaths, assessed by scrutinizing medical records.
Death of the neonate until hospital-discharge
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with respiratory distress syndrome, assessed by scrutinizing medical records.
Neonatal respiratory distress syndrome, characterized by extensive lung inflammation and surfactant catabolism leading to lung dysfunction, with need for surfactant
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with intraventricular hemorrhage, assessed by scrutinizing medical records.
Intraventricular hemorrhage grade 3 according to Papile et al., venous infarction, posthemorrhagic ventricular dilatation needing treatment
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with cystic periventricular leukomalacia, assessed by scrutinizing medical records.
Cystic periventricular leukomalacia is characterized by diffuse injury of the white matter, which possibly leads to cerebral palsy
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with retinopathy of prematurity, assessed by scrutinizing medical records.
Retinopathy of prematurity with plus disease for which treatment is needed
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with neonatal sepsis, assessed by scrutinizing medical records.
Distinction will be made in early-onset vs late-onset and clinical vs culture-proven
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with persistent pulmonary hypertension of the newborn, assessed by scrutinizing medical records.
Persistent pulmonary hypertension of the newborn occurs in case of persistent abnormally, elevated pulmonary vascular resistance after birth, leading to severe hypoxemia
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Duration of supplemental oxygen therapy during admission of the offspring (in days), assessed by scrutinizing medical records.
Measured: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates with need for mechanical ventilation < 72 hours post-partum, assessed by scrutinizing medical records.
This is defined as need for intubation and mechanical strategies to support gas exchange within 72 hours after birth
Measured: From delivery up to 72 hours after birth this outcome measure will be documented.
Number of childs with cognitive impairment, assessed by scrutinizing medical records.
A decreased ability of cognitive function using Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) at a corrected age of 24 months,. Severe disability will be defined as a Bayley Mental Development Index score more than 2SD below the mean score (i.e. ≤70). Moderate disability will be defined as a Bayley Mental Development Index score 1 to 2 SD below the mean score (i.e. 71-85)
Measured: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with motor impairment, assessed by scrutinizing medical records.
A decreased ability of fine and gross motor function using part of the Bayley Scales and Infant and Toddler Development, Third Edition (BSID-III) at corrected age of 24 months. Severe disability will be defined as a score of more than 2 SD below the mean score (i.e. ≤70). Moderate disability will be defined as a score 1 to 2SD below the mean score (i.e. 71-85)
Measured: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs diagnosed with cerebral palsy, assessed by scrutinizing medical records.
Cerebral palsy is a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain
Measured: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with hearing impairment, assessed by scrutinizing medical records.
A decreased ability of the auditory system requiring hearing aids or deafness
Measured: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with visual impairment, assessed by scrutinizing medical records.
A decreased ability of the visual system requiring aids or blindness
Measured: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of maternal deaths, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of patients diagnosed with (pre-)eclampsia, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with a Glasgow Coma Score < 13, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with a stroke or reversible ischaemic neurological deficit, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with a transient ischaemic attack, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with cortical blindness or retinal detachment, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with posterior reversible encephalopathy, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for positive inotropic support, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for infusion of a third parenteral antihypertensive drug, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with myocardial ischaemia or infarction, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with oxygen saturation below 90%, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with ≥ 50% fraction of inspired oxygen for more than one hour, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for intubation, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with pulmonary oedema, assessed by scrutinizing medical records.
Determined by pulmonary auscultation.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for transfusion of any blood product, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with a platelet count < 50x10^9 per liter with no transfusion, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with hepatic dysfunction, assessed by scrutinizing medical records.
Hepatic dysfunction defined as asparate aminotransferase and alanine aminotransferase elevated more than twice the upper limit of normal.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with hepatic haematoma or rupture, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with acute renal insufficiency, assessed by scrutinizing medical records.
Acute renal insufficiency defined as creatinine >150 μmol/L with no pre-existing renal disease.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with acute renal failure, assessed by scrutinizing medical records.
Acute renal failure defined as creatinine >200 μmol/L in patients with pre-existing renal disease.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for renal dialysis, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with placental abruption, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with severe ascites, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with Bell's palsy, assessed by scrutinizing medical records.
Measured: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start11 May 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Achmea Gezondheidszor
- Responsible party
- Principal investigator, Dr. Judith Kooiman, UMC Utrecht
- Investigators
- J. Kooiman, MD, PhD, Epidemiologist, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606497
- Sponsor's protocol ID
- 22/613
- Acronym
- OPTICORE
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36931680
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study
- ClinicalTrials.gov ID
- NCT05606497
- Acronym / sponsor ID
- OPTICORE / 22/613
- Conditions
- Fetal Growth Retardation
- Keywords
- fetal growth restriction, retrospective cohort study, antenatal corticosteroids, dynamic predictive tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Stichting Achmea Gezondheidszor
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-onset FGR | – | Drug: Corticosteroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidAlso: Antenatal corticosteroids, Betamethasone, DexamethasoneAntenatal corticosteroids are administered to pregnancies at risk for preterm birth in order to reduce risks of neonatal morbidity and mortality following preterm birth. | Drug | Early-onset FGR |
Primary outcome
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
Time frame: From date of diagnosis of early-onset FGR up to hospital-discharge of the offspring, date of death of the offspring will be documented.
This data will be validated by use of the Dutch perinatal registration data (Perined)
The primary outcome measure for the dynamic predictive tool will be defined as 'days until delivery'.
Time frame: 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.
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.
52 secondary outcomes
Mode of birth, assessed by scrutinizing medical records.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Number of stillbirths, assessed by scrutinizing medical records.
Time frame: 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.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Number of preterm births, assessed by scrutinizing medical records.
Time frame: 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.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Birthweight (in grams), assessed by scrutinizing medical records.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with birthweight < 10th percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with birthweight < 3rd percentile (according to Hoftiezer percentiles), assessed by scrutinizing medical records.
Time frame: This outcome measure will be documented by use of data from the day of birth.
Number of neonates with need for mechanical ventilation, assessed by scrutinizing medical records.
Time frame: From delivery up to hopsital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with bronchopulmonary dyspasia, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with necrotizing enterocolitis ≥ 2 according to the Bell's stages, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with neonatal seizures, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with hypoxic-ischemic encephalopathy, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonatal deaths, assessed by scrutinizing medical records.
Time frame: From delivery up to 28 days after birth of the offspring this outcome measure will be documented.
Number of in-hospital deaths, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with respiratory distress syndrome, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with intraventricular hemorrhage, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with cystic periventricular leukomalacia, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with retinopathy of prematurity, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with neonatal sepsis, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates diagnosed with persistent pulmonary hypertension of the newborn, assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Duration of supplemental oxygen therapy during admission of the offspring (in days), assessed by scrutinizing medical records.
Time frame: From delivery up to hospital-discharge of the offspring this outcome measure will be documented.
Number of neonates with need for mechanical ventilation < 72 hours post-partum, assessed by scrutinizing medical records.
Time frame: From delivery up to 72 hours after birth this outcome measure will be documented.
Number of childs with cognitive impairment, assessed by scrutinizing medical records.
Time frame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with motor impairment, assessed by scrutinizing medical records.
Time frame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs diagnosed with cerebral palsy, assessed by scrutinizing medical records.
Time frame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with hearing impairment, assessed by scrutinizing medical records.
Time frame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of childs with visual impairment, assessed by scrutinizing medical records.
Time frame: From delivery up to 24 months corrected age of the offspring this outcome measure will be documented.
Number of maternal deaths, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of patients diagnosed with (pre-)eclampsia, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with a Glasgow Coma Score < 13, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with a stroke or reversible ischaemic neurological deficit, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with a transient ischaemic attack, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with cortical blindness or retinal detachment, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with posterior reversible encephalopathy, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for positive inotropic support, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with need for infusion of a third parenteral antihypertensive drug, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers diagnosed with myocardial ischaemia or infarction, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with oxygen saturation below 90%, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Number of mothers with ≥ 50% fraction of inspired oxygen for more than one hour, assessed by scrutinizing medical records.
Time frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 36931680van 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.
Related trials for Fetal Growth Retardation
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Kooiman, MD, PhD, Epidemiologist principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J. Kooiman, MD, PhD (0031653942664, j.kooiman@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.