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

The University of Texas System (UT)

Status: Completed

Conditions: Obesity

Treatments: Diagnostic Test: Group 1 (First trimester ultrasound); Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)

Study type: Interventional

Funder types: Other

Identifiers

NCT04639973

HSC-MS-20-0895

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

Group 1 (First trimester ultrasound)

Experimental group

Treatment:

Diagnostic Test: Group 1 (First trimester ultrasound)

Group 2 (Second trimester anatomy ultrasound)

Active Comparator group

Treatment:

Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)