- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02396667
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study
July 7, 2020 updated by: dr mohamed laban, Ain Shams University
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula.
The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
60
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
Pregnant women between 37 and 42 weeks with macrosomic fetuses.
Description
Inclusion Criteria:
- 37 to 42 weeks gestation
- macrosomic fetuses
- maternal diabetes
Exclusion Criteria:
- intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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pregnant women with macrosomia
Pregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound.
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Measure the femur length by 5DLB to calculate fetal weight
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Time Frame: 72hours
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72hours
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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 (Actual)
January 1, 2018
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2022
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)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- m2493
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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