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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03715036
Other study ID # IRB #: 18-0023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date March 30, 2020

Study information

Verified date June 2021
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 exclusion criteria. 6. Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids. 7. Cerclage in the current pregnancy 8. History of intrauterine fetal demise, small for gestational age, macrosomia or shoulder dystocia, or of traumatic delivery 9. Fetal isoimmunization or alloimmunization 10. History of medical complications such as: - Cancer (including melanoma but excluding other skin cancers) - Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational). - Renal disease with altered renal function (creatinine > 0.9 or proteinuria) - Epilepsy or other seizure disorder - Any collagen disease (lupus erythematosus, scleroderma, etc.) - Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes) - Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb > 9 gm/dl). Patients with sickle cell disease are excluded. - Chronic pulmonary disease including asthma requiring regular use of medication and active TB. An asthma inhaler used on an as needed basis (PRN) for a cold or an asthma attack is not considered regular use. - Heart disease except mitral value prolapse not requiring medication - Cardiovascular disorders: chronic hypertension - Liver disorders accounting for cholestasis - Infectious diseases: HIV, CMV, toxoplasmosis, parvovirus B19 Note that the aforementioned are just examples and any clinical indication for ultrasound examination after 24 weeks is an exclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Point-of-care US
The intervention includes reassuring the AC and DVP

Locations

Country Name City State
United States University of Texas Medical Branch Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth abnormalities rate To compare the false positive rates between clinical evaluation of uterine size by SFH versus POC-US evaluation of AC and DVP. Up to 2 years
Secondary MFM ultrasounds To compare fundal height (cm) versus bedside ultrasound on the overall rate of formal MFM ultrasound requests Up to 2 years
Secondary Clinical evaluation To compare fundal height (cm) versus bedside ultrasound (abdominal circumference and Deep vertical pocket) on the prediction of birthweight < 10th percentile or > 90th percentile Up to 2 years
Secondary Maternal and neonatal outcomes 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) Up to 2 years
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