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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000683538
Date of registration: 01/07/2015
Prospective Registration: No
Primary sponsor: department of obstetrics and gynecology ,cairo univeristy, Egypt
Public title: study of brain volume in intrauterine growth restricted fetuses
Scientific title: brain volume and Doppler velocimetry in growth restricted,small for gestational age ,and average for gestational age fetuses.
Date of first enrolment: 10/03/2014
Target sample size: 240
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12615000683538.aspx
Study type:  Observational
Study design:  Purpose: Natural history;Duration: Cross-sectional;Selection: Case control;Timing: Both;  
Phase:  Not Applicable
Countries of recruitment
Egypt
Contacts
Name: A/Prof hala abd elwahab   
Address:  33 abd elwanis st, alahram,cairo, egypt. assistent professor of obstetrics and gynecolgy, cairo university, Egypt. postcode 12111 Egypt
Telephone: +20 1015777887
Email: hala_wahab20022002@yahoo.com
Affiliation: 
Name: A/Prof hala abd elwahab   
Address:  33 abd elwanis st, alahram,. cairo ,Egypt, assistant professor of obstetrics and gynecology, cairo, Egypt. postcode 12111. cairo univeristy Egypt
Telephone: + 20 1015777887
Email: hala_wahab20022002@yahoo.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: IUGR group includes pregnant women between 32 and 36 weeks of gestation with estimated fetal weights less than the 10th centiles for gestational age with brain sparing defined as MCA-PI less than 5th centile for gestational age. small for gestational age group between 32-36 weeks of gestation with estimated fetal weights less than the 10th centile for getational age and normal Doppler indices , group of average for gestational age between 32-36 weeks of gestation with estiated fetal weights between 10th and 90th centliles. all are singleton prgnancies with no structural anomalies by ultrasound
Exclusion criteria: fetuses with congenital anomalies, and those didn,t deliver in our institution

Age minimum: 22 Years
Age maximum: 35 Years
Gender: Females
Health Condition(s) or Problem(s) studied
intrauterine growth restriction;
intrauterine growth restriction
Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy
Intervention(s)
intrauterine growth restriction(IUGR) has well recognized and long term consequences.because not all fetuses found to be small in utero have true growth restriction, the distinction of true growth restriction from constitutional smallness has been one of the goals of the fetal medicine over the last 20 years. doppler ultrasound has been one of the most valuable techniques to distinguish sick IUGR from the well IUGR.Recently 3D ultrasound has been gradually introduced as valuable complementary tool for fetal evaluation offering the possibility of calculating fetal organ volumes and providing extra information on growth and maturation. the objective of our study is to analyze the possible existance of differences in the fetal brain volume between growth restricted fetuses with brain sparing , small for gestational age fetuses (SGA) with normal Doppler, and average for gestational age fetuses(AGA) and if it is possible to predict postnatal outcome depending on brain volume. in our study all patients will be subjected to conventional abdominal ultrasonography for measurments of BPD,HC, FL, AC ,of their fetuses between 32-36 weeks gestation with estimation of expected fetal weight (Hadlock 1990), Doppler ultrasonography of middle cerebral artery and umbilical artery to measure pulsatility index and resistance index and detailed 3D ULtrasound to detect brain volume . fetal biometry and 3d measurments of brain volume is done every 2 weeks for all patients. Doppler velocimetry is done every 2 weeks in AGA group, every week in SGA group, twice weekly or even daily in IUGR group. all measurments are done from enrolment till delivery
Primary Outcome(s)
to copmare the short term morbidity between growth restricted , small for gestational age , and average for gestational age neonates using the primary objective of admission to neonatal intensive care unit(NICU) OR neonatolgy service as the need need for respiratory support, intravenous fluids, antibiotics,mechnical ventilation or intubation.[NICU admmission]
Secondary Outcome(s)
none [ none]
Secondary ID(s)
none
Source(s) of Monetary Support
cairo univeristy
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
department of obstetrics and gynecology, cairo university.
Results
Results available:
Date Posted:
Date Completed:
URL:
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