- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02396654
5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study
August 4, 2017 updated by: dr mohamed laban, Ain Shams University
Accuracy of Five Dimensional Ultrasound Long Bones Fetal Biometry (5DUS LB ) for Prediction of Fetal Weight Compared to Two Dimensional Ultrasound: a Pilot Study
5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds.
Accuracy of 5D ultrasound in determining fetal weight will be determined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Ain Shams Maternity Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Normal pregnant women
Description
Inclusion Criteria:
- 20-40years
- singleton pregnancy
- normal pregnancy
Exclusion Criteria:
- Intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts by ultrasound
- maternal medical disorders like diabetes and hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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normal pregnant women
Normal pregnant women between 37 and 42 weeks gestation.
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2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula.
Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Time Frame: 48hours
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48hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
March 19, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Actual)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 4, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- m2492
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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