University of Texas Medical Branch
Galveston, Texas, 77555, United States
NCT Number: NCT03715036
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Galveston, Texas, 77555, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention includes reassuring the AC and DVP
Time frame: Up to 2 years
To compare the false positive rates between clinical evaluation of uterine size by SFH versus POC-US evaluation of AC and DVP.
Time frame: Up to 2 years
To compare fundal height (cm) versus bedside ultrasound on the overall rate of formal MFM ultrasound requests
Time frame: Up to 2 years
To compare fundal height (cm) versus bedside ultrasound (abdominal circumference and Deep vertical pocket) on the prediction of birthweight < 10th percentile or > 90th percentile
Time frame: Up to 2 years
To compare maternal (emergency CD for non reassuring FHT, chorioamnionitis/post partum endometritis, wound infection/hematoma/seroma, PRBC transfusion, admission to the ICU, DVT/PE, maternal death) and perinatal (fetal death, neonatal death, Apgar score >< 4 at 5 min, neonatal seizures, umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation at delivery, neonatal encephalopathy) outcomes between strategy of clinical evaluation of uterine size versus bedside ultrasound (abdominal circumference and Deep vertical pocket)
The University of Texas Medical Branch, Galveston
Other
Point of Care Ultrasound Screening for Abnormal Fetal Growth During Routine Antenatal Visits: a Randomized Controlled Trial. MUNN (More Ultrasounds New gaiNs) Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03420274
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Female Urogenital Diseases and Pregnancy Complications
Cleveland, Ohio, United States
View Trial DetailsNCT05360095
Genetic Counseling, Genetic Testing
Birmingham, Alabama, United States
View Trial DetailsNCT04364646
Behavior, Behavioral Symptoms
Glen Oaks, New York, United States
View Trial DetailsNCT03898440
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Brest, France
View Trial Details