Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03715036
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-10-16
Brief Title:
Point of Care Ultrasound Screening for Abnormal Fetal Growth During Routine Antenatal Visits
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
Point of Care Ultrasound Screening for Abnormal Fetal Growth During Routine Antenatal Visits a Randomized Controlled Trial MUNN More Ultrasounds New gaiNs Trial
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
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:
None
Brief Summary:
Abdominal circumference AC in the fetus is the single most useful indicator of fetal growth abnormalities Measurement of AC as well as DVP do not require extensive training Our objective is to evaluate if introduction of bedside ultrasound during routine antenatal visits to evaluate fetal AC and amniotic fluid DVP would decrease the false positive rates of fundal height measurement in diagnosing intrauterine growth abnormalities
Detailed Description:
The prior studies of routine ultrasound in low risk patients focused on the usual ultrasound evaluation which involves the use of advanced equipment and providers including trained sonographers and physicians to perform and review the ultrasound as well as a full examination with multiple fetal measurements and images A number of recent analyses show that measurement of the abdominal circumference AC in the fetus is the single most useful indicator of fetal growth abnormalities Measurement of AC as well as DVP do not require extensive training long time to acquire or expensive ultrasound machines They can be easily performed in the office by providers who are specifically trained in obtaining these 2 measurements Therefore we intended to evaluate if introduction of bedside ultrasound during routine antenatal visits point of care ultrasound or POC-US to evaluate fetal AC and amniotic fluid DVP would decrease the false positive rates of fundal height measurement in diagnosing intrauterine growth abnormalities and would improve the diagnosis of amniotic fluid volume and fetal growth deviations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None