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

NCT03857659 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2021-06-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Matthew Bicocca, MD · University of Texas Health Science Center of Houston

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2020-03-20
Completion
2020-05-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857659 on ClinicalTrials.gov