Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJuly 9, 2020
July 1, 2020
3.7 years
March 19, 2015
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
72hours
Study Arms (1)
pregnant women with macrosomia
Pregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound.
Interventions
Measure the femur length by 5DLB to calculate fetal weight
Eligibility Criteria
Pregnant women between 37 and 42 weeks with macrosomic fetuses.
You may qualify if:
- to 42 weeks gestation
- macrosomic fetuses
- maternal diabetes
You may not qualify if:
- intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Maternity Hospital
Cairo, Egypt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 19, 2015
First Posted
March 24, 2015
Study Start
January 1, 2018
Primary Completion
September 1, 2021
Study Completion
September 1, 2022
Last Updated
July 9, 2020
Record last verified: 2020-07