Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615000683538 |
Date of registration:
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01/07/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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study of brain volume in intrauterine growth restricted fetuses
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Scientific title:
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brain volume and Doppler velocimetry in growth restricted,small for gestational age ,and average for gestational age fetuses. |
Date of first enrolment:
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10/03/2014 |
Target sample size:
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240 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615000683538.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Cross-sectional;Selection: Case control;Timing: Both;
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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A/Prof hala abd elwahab
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Address:
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33 abd elwanis st, alahram,cairo, egypt. assistent professor of obstetrics and gynecolgy, cairo university, Egypt. postcode 12111
Egypt |
Telephone:
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+20 1015777887 |
Email:
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hala_wahab20022002@yahoo.com |
Affiliation:
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Name:
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A/Prof hala abd elwahab
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Address:
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33 abd elwanis st, alahram,. cairo ,Egypt, assistant professor of obstetrics and gynecology, cairo, Egypt. postcode 12111. cairo univeristy
Egypt |
Telephone:
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+ 20 1015777887 |
Email:
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hala_wahab20022002@yahoo.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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intrauterine growth restriction; intrauterine growth restriction
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Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy
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Intervention(s)
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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
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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none [ none]
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Source(s) of Monetary Support
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cairo univeristy
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Ethics review
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Status: Approved
Approval date:
Contact:
department of obstetrics and gynecology, cairo university.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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