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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Diagnostic Test: Group 1 (First trimester ultrasound)
* Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (First trimester ultrasound)<br> | Diagnostic Test: Group 1 (First trimester ultrasound)<br>* 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.<br>|
| Active Comparator: Group 2 (Second trimester anatomy ultrasound)<br> | Diagnostic Test: Group 2 (Second trimester anatomy ultrasound)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Participants With Infants Who Survive |  | 9 months from randomization | 
| Gestational Age at Delivery |  | at the time of delivery (about 40 weeks of pregnancy) | 
| 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) | 
| Hospital Length of Stay |  | from time of hospital admission to discharge (about 0 to 365 days after birth) | 
| Number of Participants With Infants With Neonatal Morbidities | Neonatal morbidities include hypoglycemia | 9 months from randomization | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, fetal ultrasound