Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Completion Rate for First Trimester Scans
- Status
- Completed
- Last Updated
- last year
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.
Investigators
Cara Buskmiller
Fellow
The University of Texas Health Science Center, Houston
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
Outcomes
Primary Outcomes
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
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
- 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)
- Completion Rate of First Trimester and Second Trimester Scans(12-22 weeks of pregnancy)
- Time Taken to Complete Scan in the First Trimester Ultrasound Group(12-14 weeks of pregnancy)
- Number of Participants With Infants With Neonatal Morbidities(9 months from randomization)
- 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 Admitted to the Neonatal Intensive Care Unit (NICU)(at the time of NICU admission (about 0 to 28 days after birth))
- Cost of Intervention Compared to Usual Care(from 12-22 weeks of pregnancy)