Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000683538
Ethics application status
Approved
Date submitted
11/04/2015
Date registered
1/07/2015
Date last updated
9/06/2016
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 286677 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intrauterine growth restriction 294726 0
Condition category
Condition code
Reproductive Health and Childbirth 295016 295016 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 291603 0
Not applicable
Comparator / control treatment
control group are healthy pregnant women with estimated fetal weights beween 10th and 90th percentile
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294770 0
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.
Timepoint [1] 294770 0
NICU admmission
Secondary outcome [1] 314015 0
none
Timepoint [1] 314015 0
none

Eligibility
Key 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
Minimum age
22 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
fetuses with congenital anomalies, and those didn,t deliver in our institution

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
data will be statstically described in terms of mean+SD,and percentages. our study is pilot study so no sample size calculation was done.our study will be applied on larger study depending on provisional results

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
10/03/2014
Date of last participant enrolment
Anticipated
1/03/2015
Actual
10/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
216
Recruitment outside Australia
Country [1] 6802 0
Egypt
State/province [1] 6802 0
cairo

Funding & Sponsors
Funding source category [1] 291078 0
University
Name [1] 291078 0
cairo univeristy
Country [1] 291078 0
Egypt
Primary sponsor type
University
Name
department of obstetrics and gynecology ,cairo univeristy, Egypt
Address
1 Alsaraya street,Almanial,cairo, Egypt.post code 11562
Country
Egypt
Secondary sponsor category [1] 289755 0
None
Name [1] 289755 0
none
Address [1] 289755 0
none
Country [1] 289755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292661 0
department of obstetrics and gynecology, cairo university.
Ethics committee address [1] 292661 0
Ethics committee country [1] 292661 0
Egypt
Date submitted for ethics approval [1] 292661 0
01/02/2014
Approval date [1] 292661 0
01/03/2014
Ethics approval number [1] 292661 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56434 0
A/Prof hala abd elwahab
Address 56434 0
33 abd elwanis st, alahram,cairo, egypt. assistent professor of obstetrics and gynecolgy, cairo university, Egypt.postcode 12111
Country 56434 0
Egypt
Phone 56434 0
+20 1015777887
Fax 56434 0
+20 37803439
Email 56434 0
[email protected]
Contact person for public queries
Name 56435 0
hala abd elwahab
Address 56435 0
33 abd elwanis st, alahram,cairo, egypt. assistent professor of obstetrics and gynecolgy, cairo university, Egypt. postcode 12111
Country 56435 0
Egypt
Phone 56435 0
+20 1015777887
Fax 56435 0
+20 37803439
Email 56435 0
[email protected]
Contact person for scientific queries
Name 56436 0
hala abd elwahab
Address 56436 0
33 abd elwanis st, alahram,. cairo ,Egypt, assistant professor of obstetrics and gynecology, cairo, Egypt. postcode 12111. cairo univeristy
Country 56436 0
Egypt
Phone 56436 0
+ 20 1015777887
Fax 56436 0
+20 37803439
Email 56436 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.