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

October 31, 2022 updated by: Dr. Judith Kooiman, UMC Utrecht
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 EA
        • Recruiting
        • UMC Utrecht, Wilhelmina Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Early-onset FGR
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.
Other Names:
  • Dexamethasone
  • Betamethasone
  • Antenatal corticosteroids

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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'.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Mode of birth defined as vaginal or caesarian section.
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.
Stillbirth is defined as death of fetus ante- or intrapartum
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.
Gestational age will be recorded in weeks as well.
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.
Preterm birth defined as delivery before 37.0 weeks of gestational age.
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.
Extremely preterm birth is defined as delivery before 28 weeks of gestational age.
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.
Birthweight defined as weight at time of birth (in grams)
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.
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.
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.
Mechanical ventilation defined as need for intubation and mechanical ventilation to support gas exchange
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.
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
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.
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.
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
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.
Hypoxic-ischemic encephalopathy defined as a clinical syndrome that results from a severe or prolonged hypoxic-ischemic episode before or during birth
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.
Death of the neonate within 28 days after birth
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.
Death of the neonate until hospital-discharge
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.
Neonatal respiratory distress syndrome, characterized by extensive lung inflammation and surfactant catabolism leading to lung dysfunction, with need for surfactant
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.
Intraventricular hemorrhage grade 3 according to Papile et al., venous infarction, posthemorrhagic ventricular dilatation needing treatment
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.
Cystic periventricular leukomalacia is characterized by diffuse injury of the white matter, which possibly leads to cerebral palsy
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.
Retinopathy of prematurity with plus disease for which treatment is needed
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.
Distinction will be made in early-onset vs late-onset and clinical vs culture-proven
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.
Persistent pulmonary hypertension of the newborn occurs in case of persistent abnormally, elevated pulmonary vascular resistance after birth, leading to severe hypoxemia
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.
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.
This is defined as need for intubation and mechanical strategies to support gas exchange within 72 hours after birth
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.
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)
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.
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)
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.
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
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.
A decreased ability of the auditory system requiring hearing aids or deafness
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.
A decreased ability of the visual system requiring aids or blindness
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Determined by pulmonary auscultation.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Hepatic dysfunction defined as asparate aminotransferase and alanine aminotransferase elevated more than twice the upper limit of normal.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Acute renal insufficiency defined as creatinine >150 μmol/L with no pre-existing renal disease.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
Acute renal failure defined as creatinine >200 μmol/L in patients with pre-existing renal disease.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
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.
Time Frame: From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.
From diagnosis of early-onset FGR up to six weeks post-partum this outcome measure will be documented.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UMC Utrecht

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stichting Achmea Gezondheidszor

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. Kooiman, MD, PhD, Epidemiologist, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/613

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings