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Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)

NCT04639973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-05-21

Study results available
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Summary

The purpose of this study is to assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of one ultrasound in the first trimester and one in the second trimesters compared to the individual completion rates of both evaluations in obese pregnant women.

Conditions

Interventions

DIAGNOSTIC_TEST

Group 1 (First trimester ultrasound)

A detailed first trimester anatomy ultrasound will be performed,at the visit when the subject is confirmed to be of eligible gestational age. After this detailed research ultrasound, which will be limited to 15 minutes, subject will then receive the clinically indicated dating ultrasound or nuchal translucency measurement. The patient will complete a survey about her satisfaction with this technique via email.as a safety measure, if an anomaly is suspected on the day of the detailed first trimester anatomy scan, the patient will be unblinded. Patients in this arm are later scheduled for a second trimester ultrasound by the clinical team, as this is part of standard obstetrical care.

DIAGNOSTIC_TEST

Group 2 (Second trimester anatomy ultrasound)

Patients do not undergo a detailed first trimester ultrasound , but will receive the clinically indicated limited ultrasound for dating or for nuchal translucency. Patient will then undergoes a second trimester ultrasound by the clinical team as part of standard obstetrical care and completes a survey regarding her satisfaction with this technique via email.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Cara Buskmiller, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-04-30
Completion
2022-11-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04639973 on ClinicalTrials.gov