Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201912713000599 Date of Approval: 09/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cortical development in fetal growth restriction
Official scientific title Ultrasonographic Evaluation of Cerebral Cortical Development in Growth Restricted Versus Matched Average Gestational Age Fetuses
Brief summary describing the background and objectives of the trial Fetal growth restriction (FGR) is a frequent condition in perinatal medicine, accounting about 5-8% prevalence from live newborn babies. In fetal growth restriction the ‘brain sparing effect’, refers to the cerebroplacental blood flow redistribution due to placental insufficiency measured with Doppler ultrasound. Fetal brain development is a complicated yet highly organized progressive process that continues throughout pregnancy. Assessment of fetal sulcus development to understand the cortical maturation and development by prenatal ultrasound has become widespread. The aim of this work is to assess cortical development in fetal growth-restricted and matched average gestational age fetuses by ultrasonography using two and three dimensional ultrasonography: 1- Insular depths will be measured in the axial transventricular plane. 2-Sylvian fissure depths will be measured in the same plane described above. 3-Calcarine fissure will be measured in the coronal trans-cerebellar plane, tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissure. 4-Cingulate fissure will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissure. 5- Corpus callosum length will be measured from the most anterior part of the genu to the most posterior part of the splenium . 6- Corpus callosum thickness will be measured in its anterior, middle and posterior portions corresponding to the genu, body and splenium thickness.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/12/2019
Actual trial start date
Anticipated date of last follow up 15/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasonography Once at 24-40 weeks of gestation Assessment of cortical development in fetal growth-restricted fetuses using two and three-dimensional ultrasonography 150
Control Group MRI group Once at 24-40 weeks of gestation Assessment of cortical development in fetal growth-restricted fetuses using 9.0 MRI software 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton pregnancy. Gestational age 24-40 weeks Fetal structural anomalies Chromosomal anomalies Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/11/2019 Ethics Committee of Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Insular depth Once at 24-40 weeks of gestation
Primary Outcome Sylvian fissure depths Once at 24-40 weeks of gestation
Primary Outcome Calcarine fissure Once at 24-40 weeks of gestation
Primary Outcome Cingulate fissure Once at 24-40 weeks of gestation
Primary Outcome Corpus callosum length. Once at 24-40 weeks of gestation
Primary Outcome Corpus callosum thickness Once at 24-40 weeks of gestation
Secondary Outcome Neurological development in fetal growth Till age of 3 years of the newborn
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Shatby Obstetrics and Gynecology hospital Alexandria university Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amany Ibrahim Mohammed Azab Suez Canal road, Port said street, El shatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obstetrics and Gynecology Department Faculty of Medicine Portsaid street, El Shatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tarek Abd El Zaher Karkour Shatby Hospital For Obstetrics and Gynaecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
Tamer Mamdouh Abd El Dayem Shatby Hospital For Obstetrics and Gynaecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
Tamer Mohammed Abd El Aziz Ibrahim Hassan Shatby Hospital For Obstetrics and Gynaecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
Amany Ibrahim Mohammed Azab Shatby Hospital For Obstetrics and Gynaecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Karkour tarekkarkoor@gmail.com 00201223152544 Shatby Hospital For Obstetrics and Gynecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Obstetrics and Gynecology Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Scientific Enquiries Amany Azab Amanymed2011@yahoo.com 00201017695069 Shatby Hospital For Obstetrics and Gynecology Suez Canal Rd, Al Azaritah WA Ash Shatebi Qism Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Obstetrics and Gynecology Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 4 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information