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

The University of Texas Health Science Center, Houston128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

128

Conditions

Obesity

Interventions

Group 1 (First trimester ultrasound)DIAGNOSTIC_TEST

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.

Group 2 (Second trimester anatomy ultrasound)DIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI greater than or equal to 35 * Presented for ultrasound before 14 weeks at The University of Texas Professional Building, Memorial City, Bellaire, or Lyndon-Baines Johnson clinics * Primary language is English or Spanish * Consent to an extra transvaginal ultrasound if needed * Singleton gestation * No previous anomalies known before consent * Missed abortion (nonviable pregnancy) Exclusion Criteria: * Elective abortion after recruitment * Missed abortion after first trimester ultrasound * Did not receive second trimester ultrasound

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Completion Rate for First Trimester Scans

Completion rate is reported as the number of scans that see all the views divided by total number of scans in that group

Time frame: 12-14 weeks of pregnancy

Completion Rate for Second Trimester Scans

Completion rate is reported as the number of scans that see all the views divided by total number of scans.

Time frame: 18-22 weeks of pregnancy

Secondary Outcomes

Completion Rate of First Trimester and Second Trimester Scans

This outcome is reported as \[(# of completed 1st tri anatomy scans) + (# of completed 2nd tri anatomy scans in women without a completed first tri anatomy scan)\]/(total number of women in first trimester group).

Time frame: 12-22 weeks of pregnancy

Time Taken to Complete Scan in the First Trimester Ultrasound Group

Time frame: 12-14 weeks of pregnancy

Number of Anomalies Identified in First Trimester Group Scans

Time frame: 12-14 weeks of pregnancy

Number of Anomalies Identified in Second Trimester Group Scans

Time frame: 12-22 weeks of pregnancy

Number of Anomalies Missed in First Trimester Group Scans

Time frame: 12-14 weeks of pregnancy

Number of Anomalies Missed in Second Trimester Group Scans

Time frame: 12-22 weeks of pregnancy

Number of Participants With Infants Who Survive

Data from ClinicalTrials.gov

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