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

NCT04639973 | Completed Results FDA Device

• 1 other identifier: HSC-MS-20-0895
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

pregnancy; fetal ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Completion Rate of First Trimester and Second Trimester Scans

  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

Study Arms (2)

Group 1 (First trimester ultrasound)

EXPERIMENTAL

Diagnostic Test: Group 1 (First trimester ultrasound)

Group 2 (Second trimester anatomy ultrasound)

ACTIVE COMPARATOR

Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)

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 1 (First trimester ultrasound)

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.

Group 2 (Second trimester anatomy ultrasound)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Elective abortion after recruitment
• Missed abortion after first trimester ultrasound
• Did not receive second trimester ultrasound

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Buskmiller C, Fishel Bartal M, Bonilla M, Denham C, Nguyen R, Sibai B, Pedroza C, Hernandez-Andrade E. First trimester anatomy ultrasound for patients with obesity: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101143. doi: 10.1016/j.ajogmf.2023.101143. Epub 2023 Sep 3.

  PMID: 37669739 RESULT

• Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. A Learning Curve for First-Trimester Anatomy Ultrasound in Obese Patients. Gynecol Obstet Invest. 2024;89(4):346-350. doi: 10.1159/000538477. Epub 2024 Mar 22.

  PMID: 38522420 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cara Buskmiller, MD
• Organization: Baylor College of Medicine

cara.buskmiller@bcm.edu

832-824-1000

Study Officials

• Cara Buskmiller, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: November 21, 2022
• Last Updated: May 21, 2024
• Results First Posted: July 13, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)