NCT03857659

Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care

Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study us to compare the rate of prenatal identification of abnormal fetal growth or amniotic fluid between clinical evaluation of uterine size by symphysis fundal height (SFH) measurements versus point-of-care ultrasound (POC-US) evaluation of abdominal circumference (AC) and maximum vertical pocket (MVP).

Conditions

• Fetal Growth Abnormality
• Amniotic Fluid; Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point-of-care ultrasound (POC-US)	POC-US evaluation will be conducted using the portable ultrasound machine, which is capable of straight-line measurements for assessment of the amniotic fluid, as well as ellipse measurements for determination of abdominal circumference. POC-US evaluation will be conducted every 4 weeks from 28-36 weeks.
DIAGNOSTIC_TEST	Routine antenatal care	Routine care with fundal height measurement at each antenatal appointment every 2 weeks from 28-36 weeks. As well as clinically indicated obstetric ultrasound by a Registered Diagnostic Medical Sonographer (RDMS)
DIAGNOSTIC_TEST	Formal ultrasound	Formal growth ultrasound performed between 36-38.6 weeks by RDMS.

Timeline

• Start date: 2019-04-05
• Primary completion: 2020-03-20
• Completion: 2020-05-20
• First posted: 2019-02-28
• Last updated: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study