Ignite Creation Date:
2024-05-06 @ 2:10 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01981824
Status:
UNKNOWN
Last Update Posted:
2013-11-13
First Post:
2013-11-06
Brief Title:
Prediction of Growth Restricted Fetuses Using Femur Length to Mid-thigh Circumference Ratio A Case-control Study
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
Official Title:
Femur Length to Mid-thigh Circumference Ratio in Prediction of IUGR
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUGR
Brief Summary:
One of the most challenging areas currently facing obstetricians is the detection and management of pregnancies in which the growth of the fetus is poor These fetuses have not only increased rates of perinatal morbidity and mortality but also have higher levels of morbidity extending into adult life Linda Murray 2010
In developing countries including Egypt low birth weight is a national concern and emphasized in population and health policies according to the latest WHO data published in April 2011 low Birth Weight Deaths in Egypt reached 13587 or 374 of total deaths Mortality was more frequent in LBW 316 than normal birth weight NBW infants 20
Fetal growth restriction FGR is defined as fetuses whose growth velocity slows down or stops completely because of inadequate oxygen and nutritional supply or utilization Linda Murray 2010 Low birth weight LBW refers to an infant with a birth weight 2500 g Small for gestational age SGA birth is defined as an estimated fetal weight EFW less than the 10th centile and severe SGA as an EFW less than the 3rd centile RCOG Green-top Guideline No31 2013
Ultrasound has been used as a tool for determining fetal health and a variety of sonographic parameters have been used to screen and diagnose IUGR including fetal biometry fetal body proportions Campbell et al 1994 amniotic fluid volume Owen et al 1999 subcutaneous tissue thickness and estimated fetal weight EFW Larciprete et al 2005
IUGR is associated with changes in the body proportions as undernourished fetus directs most of its energy to maintain the growth of vital organs such as the brain and heart at the expense of the liver muscle and fat and this results in decreased abdominal and thigh circumference measurements and hence theoretically increased HCAC FLAC and FLTC ratios Colley et al 1991
Fetal thigh circumference has a role to play in accurately measuring fetal weight when incorporated with other fetal parameters and provide a potentially straightforward method for assessing the deposition of muscle and fat in the growing fetus there is a scope of using the FLTC ratio in predicting IUGR Sanyal et al 2012
Fetal thigh circumference to femur length ratio FLTC seems to be potential for use in predicting IUGR Shripad Varalaxmi 2005
In developing countries including Egypt low birth weight is a national concern and emphasized in population and health policies according to the latest WHO data published in April 2011 low Birth Weight Deaths in Egypt reached 13587 or 374 of total deaths Mortality was more frequent in LBW 316 than normal birth weight NBW infants 20
Fetal growth restriction FGR is defined as fetuses whose growth velocity slows down or stops completely because of inadequate oxygen and nutritional supply or utilization Linda Murray 2010 Low birth weight LBW refers to an infant with a birth weight 2500 g Small for gestational age SGA birth is defined as an estimated fetal weight EFW less than the 10th centile and severe SGA as an EFW less than the 3rd centile RCOG Green-top Guideline No31 2013
Ultrasound has been used as a tool for determining fetal health and a variety of sonographic parameters have been used to screen and diagnose IUGR including fetal biometry fetal body proportions Campbell et al 1994 amniotic fluid volume Owen et al 1999 subcutaneous tissue thickness and estimated fetal weight EFW Larciprete et al 2005
IUGR is associated with changes in the body proportions as undernourished fetus directs most of its energy to maintain the growth of vital organs such as the brain and heart at the expense of the liver muscle and fat and this results in decreased abdominal and thigh circumference measurements and hence theoretically increased HCAC FLAC and FLTC ratios Colley et al 1991
Fetal thigh circumference has a role to play in accurately measuring fetal weight when incorporated with other fetal parameters and provide a potentially straightforward method for assessing the deposition of muscle and fat in the growing fetus there is a scope of using the FLTC ratio in predicting IUGR Sanyal et al 2012
Fetal thigh circumference to femur length ratio FLTC seems to be potential for use in predicting IUGR Shripad Varalaxmi 2005
Detailed Description:
Aim of work To determine usefulness of antenatally measured femur length to mid thigh circumference ratio to predict intra-uterine growth restricted fetuses
Study design Observational Case-Control study Study population This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic emergency department and from inpatient wards of Ain Shams University Maternity Hospital from the period of October 2013 to October 2014
This study will include 100 pregnant women these cases will divided into 2 groups
1 Normal growth Fetuses Group will include 50 pregnant females all in third trimester
2 IUGR fetuses Group will include 50 pregnant females all in third trimester
Inclusion criteria
1 all pregnant women aged between 20-40 years
2 Singleton pregnancy
3 Gestational age of 28-40 weeks and
4 Reliable dates by early antenatal ultrasound
Exclusion criteria
1 Ultrasonographically detected congenital fetal malformation
2 Fetal hydrops
3 Multiple pregnancy
4 Post-term pregnancy
5 Intrauterine fetal death
Study design Observational Case-Control study Study population This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic emergency department and from inpatient wards of Ain Shams University Maternity Hospital from the period of October 2013 to October 2014
This study will include 100 pregnant women these cases will divided into 2 groups
1 Normal growth Fetuses Group will include 50 pregnant females all in third trimester
2 IUGR fetuses Group will include 50 pregnant females all in third trimester
Inclusion criteria
1 all pregnant women aged between 20-40 years
2 Singleton pregnancy
3 Gestational age of 28-40 weeks and
4 Reliable dates by early antenatal ultrasound
Exclusion criteria
1 Ultrasonographically detected congenital fetal malformation
2 Fetal hydrops
3 Multiple pregnancy
4 Post-term pregnancy
5 Intrauterine fetal death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None