Prenatal Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTPoint-of-care US
The intervention includes reassuring the AC and DVP
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Maternal age ≥ 18 years and ability to give informed consent 2. Singleton gestation 3. Ultrasound examination that confirms or revises the EDD before 22 0/7 weeks of gestational age (ACOG Committee opinion 2017 dating) 4. Gestational age ≥ 24 weeks gestation
Exclusion criteria
1. Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) 2. Fetal chromosomal or genetic abnormalities 3. Fetal malformations or soft markers identified on fetal anatomy survey 4. Current pregnancy is a result of in vitro fertilization 5. Documented uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth abnormalities rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MFM ultrasounds | Up to 2 years | To compare fundal height (cm) versus bedside ultrasound on the overall rate of formal MFM ultrasound requests |
| Clinical evaluation | 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 |
| Maternal and neonatal outcomes | 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) |
Countries
United States
Outcome results
None listed