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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639973
• Other study ID #: HSC-MS-20-0895
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 21, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & 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: 10.101 — View Citation

Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. A learning curve for first trimester anatomy ultrasound in obese patients. Gynecol Obstet Invest. 2024 Mar 22. doi: 10.1159/000538477. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Time Taken to Complete Scan in the First Trimester Ultrasound Group		12-14 weeks of pregnancy
Secondary	Number of Anomalies Identified in First Trimester Group Scans		12-14 weeks of pregnancy
Secondary	Number of Anomalies Identified in Second Trimester Group Scans		12-22 weeks of pregnancy
Secondary	Number of Anomalies Missed in First Trimester Group Scans		12-14 weeks of pregnancy
Secondary	Number of Anomalies Missed in Second Trimester Group Scans		12-22 weeks of pregnancy
Secondary	Number of Participants With Infants Who Survive		9 months from randomization
Secondary	Gestational Age at Delivery		at the time of delivery (about 40 weeks of pregnancy)
Secondary	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)
Secondary	Hospital Length of Stay		from time of hospital admission to discharge (about 0 to 365 days after birth)
Secondary	Number of Participants With Infants With Neonatal Morbidities	Neonatal morbidities include hypoglycemia	9 months from randomization
Secondary	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
Secondary	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