Point of Care Ultrasound Screening for Abnormal Fetal Growth During Routine Antenatal Visits: a Randomized Controlled Trial. MUNN (More Ultrasounds New gaiNs) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prenatal Disorder
- Sponsor
- The University of Texas Medical Branch, Galveston
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- Growth abnormalities rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Maternal age ≥ 18 years and ability to give informed consent
- •Singleton gestation
- •Ultrasound examination that confirms or revises the EDD before 22 0/7 weeks of gestational age (ACOG Committee opinion 2017 dating)
- •Gestational age ≥ 24 weeks gestation
Exclusion Criteria
- •Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT)
- •Fetal chromosomal or genetic abnormalities
- •Fetal malformations or soft markers identified on fetal anatomy survey
- •Current pregnancy is a result of in vitro fertilization
- •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.
- •Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.
- •Cerclage in the current pregnancy
- •History of intrauterine fetal demise, small for gestational age, macrosomia or shoulder dystocia, or of traumatic delivery
- •Fetal isoimmunization or alloimmunization
- •History of medical complications such as:
Outcomes
Primary Outcomes
Growth abnormalities rate
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.
Secondary Outcomes
- MFM ultrasounds(Up to 2 years)
- Clinical evaluation(Up to 2 years)
- Maternal and neonatal outcomes(Up to 2 years)