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

Not Applicable

Completed

Conditions: Obesity

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

Registration Number: NCT04639973

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 128

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (First trimester ultrasound)	Group 1 (First trimester ultrasound)	-
Group 2 (Second trimester anatomy ultrasound)	Group 2 (Second trimester anatomy ultrasound)	-

Primary Outcome Measures

Name	Time	Method
Completion Rate for First Trimester Scans	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
Completion Rate for Second Trimester Scans	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 Outcome Measures

Name	Time	Method
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)
Hospital Length of Stay	from time of hospital admission to discharge (about 0 to 365 days after birth)
Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans	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. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied
Completion Rate of First Trimester and Second Trimester Scans	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).
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 Participants With Infants With Neonatal Morbidities	9 months from randomization	Neonatal morbidities include hypoglycemia
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
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)