Fetal Growth RestrictionIUGRNCT01981824
Prediction of Growth Restricted Fetuses Using Femur Length to Mid-thigh Circumference Ratio: A Case-control Study
An observational study of Fetal Growth Restriction, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- all pregnant women aged between 20-40 years ,
- Singleton pregnancy,
- Gestational age of 28-40 weeks, and
- Reliable dates by early antenatal ultrasound. -
Who cannot join
- Ultrasonographically detected congenital fetal malformation,
- Fetal hydrops,
- Multiple pregnancy,
- Post-term pregnancy,
- Intrauterine fetal death. -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo, Abbassia, 11566
Alaa Sayed Abdul-hafeez, MD, 201002554281, alaa.s.abdulhafeez@facebook.com
About this study
Official title: Femur Length to Mid-thigh Circumference Ratio in Prediction of IUGR
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 13,587 or 3.74% of total deaths, Mortality was more frequent in LBW (31.6%) than normal birth weight (NBW) infants (2.0%).
Read more
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 No.31, 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 HC/AC, FL/AC and FL/TC 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 FL/TC ratio in predicting IUGR (Sanyal et al., 2012).
Fetal thigh circumference to femur length ratio (FL/TC) seems to be potential for use in predicting IUGR (Shripad; Varalaxmi, 2005).
Read the 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:
- Normal growth Fetuses Group: will include 50 pregnant females all in third trimester.
- IUGR fetuses Group: will include 50 pregnant females all in third trimester.
Inclusion criteria:
- all pregnant women aged between 20-40 years ,
- Singleton pregnancy,
- Gestational age of 28-40 weeks, and
- Reliable dates by early antenatal ultrasound.
Exclusion criteria:
- Ultrasonographically detected congenital fetal malformation,
- Fetal hydrops,
- Multiple pregnancy,
- Post-term pregnancy,
- Intrauterine fetal death.
- Conditions
- Fetal Growth Restriction
- Keywords
- prediction IUGR FL/MTC
- Medical subject headings
- Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
femur length to mid-thigh circumference ratio
To determine usefulness of antenatally measured femur length to mid thigh circumference ratio to predict intra-uterine growth restricted fetuses.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Sayed Abdul-hafeez, Ain Shams Maternity Hospital
- Investigators
- Alaa sayed abdul-Hafeez, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981824
- Sponsor's protocol ID
- 11110000
- Acronym
- IUGR
- Status last verified
- Oct 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femur Length to Mid-thigh Circumference Ratio in Prediction of IUGR
- ClinicalTrials.gov ID
- NCT01981824
- Acronym / sponsor ID
- IUGR / 11110000
- Conditions
- Fetal Growth Restriction
- Keywords
- prediction IUGR FL/MTC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 13,587 or 3.74% of total deaths, Mortality was more frequent in LBW (31.6%) than normal birth weight (NBW) infants (2.0%).
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 No.31, 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 HC/AC, FL/AC and FL/TC 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 FL/TC ratio in predicting IUGR (Sanyal et al., 2012).
Fetal thigh circumference to femur length ratio (FL/TC) 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:
- Normal growth Fetuses Group: will include 50 pregnant females all in third trimester.
- IUGR fetuses Group: will include 50 pregnant females all in third trimester.
Inclusion criteria:
- all pregnant women aged between 20-40 years ,
- Singleton pregnancy,
- Gestational age of 28-40 weeks, and
- Reliable dates by early antenatal ultrasound.
Exclusion criteria:
- Ultrasonographically detected congenital fetal malformation,
- Fetal hydrops,
- Multiple pregnancy,
- Post-term pregnancy,
- Intrauterine fetal death.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- all pregnant women aged between 20-40 years ,
- Singleton pregnancy,
- Gestational age of 28-40 weeks, and
- Reliable dates by early antenatal ultrasound. -
Key exclusion criteria (5 listed)
- Ultrasonographically detected congenital fetal malformation,
- Fetal hydrops,
- Multiple pregnancy,
- Post-term pregnancy,
- Intrauterine fetal death. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
femur length to mid-thigh circumference ratio
Time frame: one year
To determine usefulness of antenatally measured femur length to mid thigh circumference ratio to predict intra-uterine growth restricted fetuses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa sayed abdul-Hafeez, MD principal investigator
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Sayed Abdul-hafeez, MD (201002554281, alaa.s.abdulhafeez@facebook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
femur length to mid-thigh circumference ratio (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.