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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04639973

Collaborator

(none)

118

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Diagnostic Test: Group 1 (First trimester ultrasound) Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Completion rate for first trimester scans [12-14 weeks of pregnancy]
Measured by number of scans that see all the views divided by total number of scans in that group
Completion rate for second trimester scans [18-22 weeks of pregnancy]
Measured by number of scans that see all the views divided by total number of scans in that group

Secondary Outcome Measures

Completion rate of first trimester and second trimester scans [12-22 weeks of pregnancy]
when considered as a single instrument to visualize the fetal anatomy
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 infants who survive [9 months from randomization]
Gestational age at delivery [at the time of delivery (about 40 weeks of pregnancy)]
Number of participants 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 infants with neonatal morbidities [9 months from randomization]
Neonatal morbidities include respiratory distress syndrome, transient tachypnea of the newborn, intraventricular haemorrhage, necrotizing enterocolitis
Patient satisfaction as measured by the standardized survey [6 months from randomization]
Cost of intervention compared to usual care [from 12-22 weeks of pregnancy]
cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cara Buskmiller, Fellow, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04639973

Other Study ID Numbers:

HSC-MS-20-0895

First Posted:

Nov 23, 2020

Last Update Posted:

Jun 3, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Cara Buskmiller, Fellow, The University of Texas Health Science Center, Houston

pregnancy

fetal ultrasound

Study Results

No Results Posted as of Jun 3, 2022