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Completed

NCT Number: NCT04639973

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Completion Rate for First Trimester Scans

    Time frame: 12-14 weeks of pregnancy

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

  2. Completion Rate for Second Trimester Scans

    Time frame: 18-22 weeks of pregnancy

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

Secondary outcomes

  1. Completion Rate of First Trimester and Second Trimester Scans

    Time frame: 12-22 weeks of pregnancy

    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).

  2. Time Taken to Complete Scan in the First Trimester Ultrasound Group

    Time frame: 12-14 weeks of pregnancy

  3. Number of Anomalies Identified in First Trimester Group Scans

    Time frame: 12-14 weeks of pregnancy

  4. Number of Anomalies Identified in Second Trimester Group Scans

    Time frame: 12-22 weeks of pregnancy

  5. Number of Anomalies Missed in First Trimester Group Scans

    Time frame: 12-14 weeks of pregnancy

  6. Number of Anomalies Missed in Second Trimester Group Scans

    Time frame: 12-22 weeks of pregnancy

  7. Number of Participants With Infants Who Survive

    Time frame: 9 months from randomization

  8. Gestational Age at Delivery

    Time frame: at the time of delivery (about 40 weeks of pregnancy)

  9. Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)

    Time frame: at the time of NICU admission (about 0 to 28 days after birth)

  10. Hospital Length of Stay

    Time frame: from time of hospital admission to discharge (about 0 to 365 days after birth)

  11. Number of Participants With Infants With Neonatal Morbidities

    Time frame: 9 months from randomization

    Neonatal morbidities include hypoglycemia

  12. Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans

    Time frame: 6 months from randomization

    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

  13. Cost of Intervention Compared to Usual Care

    Time frame: from 12-22 weeks of pregnancy

    cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2020
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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