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

Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Diagnostic test: Group 1 (First trimester ultrasound); Diagnostic test: Group 2 (Second trimester anatomy ultrasound)

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (First trimester ultrasound)	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.
Active Comparator: Group 2 (Second trimester anatomy ultrasound)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	18-22 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12-22 weeks of pregnancy
Time Taken to Complete Scan in the First Trimester Ultrasound Group		12-14 weeks of pregnancy
Number of Anomalies Identified in First Trimester Group Scans		12-14 weeks of pregnancy
Number of Anomalies Identified in Second Trimester Group Scans		12-22 weeks of pregnancy
Number of Anomalies Missed in First Trimester Group Scans		12-14 weeks of pregnancy
Number of Anomalies Missed in Second Trimester Group Scans		12-22 weeks of pregnancy
Number of Participants With Infants Who Survive		9 months from randomization
Gestational Age at Delivery		at the time of delivery (about 40 weeks of pregnancy)
Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)		at the time of NICU admission (about 0 to 28 days after birth)
Hospital Length of Stay		from time of hospital admission to discharge (about 0 to 365 days after birth)
Number of Participants With Infants With Neonatal Morbidities	Neonatal morbidities include hypoglycemia	9 months from randomization
Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans	The survey asks "Overall, how satisfied were you with today's ultrasound?," and participants selected one of the below choices. Number who chose "Very Satisfied" is reported.; Very satisfied; Somewhat satisfied; Neither satisfied nor dissatisfied; Somewhat dissatisfied; Very dissatisfied	6 months from randomization
Cost of Intervention Compared to Usual Care	cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies	from 12-22 weeks of pregnancy

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Cara Buskmiller, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): November 21, 2022

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; fetal ultrasound
• Other Study ID Numbers: HSC-MS-20-0895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No