N/A
N=128
Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04639973 ↗Enrolled (actual)
128
Serious AEs
4.7%
Results posted
Jul 2023
Primary outcome: Primary: Completion Rate for First Trimester Scans — 66 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group 1 (First trimester ultrasound) (Diagnostic_test); Group 2 (Second trimester anatomy ultrasound) (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate for First Trimester Scans |
66 | — |
| PRIMARY Completion Rate for Second Trimester Scans |
53 | — |
| SECONDARY Completion Rate of First Trimester and Second Trimester Scans |
82.8 | — |
| SECONDARY Time Taken to Complete Scan in the First Trimester Ultrasound Group |
65 | — |
| SECONDARY Number of Anomalies Identified in First Trimester Group Scans |
5 | — |
| SECONDARY Number of Anomalies Identified in Second Trimester Group Scans |
6 | — |
| SECONDARY Number of Anomalies Missed in First Trimester Group Scans |
3 | — |
| SECONDARY Number of Anomalies Missed in Second Trimester Group Scans |
— | — |
| SECONDARY Number of Participants With Infants Who Survive |
57; 60 | — |
| SECONDARY Gestational Age at Delivery |
37.4; 37.5 | — |
| SECONDARY Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) |
18; 8 | — |
| SECONDARY Hospital Length of Stay |
8; 18 | — |
| SECONDARY Number of Participants With Infants With Neonatal Morbidities |
9; 3 | — |
| SECONDARY Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans |
30 | — |
| SECONDARY Cost of Intervention Compared to Usual Care |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04639973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.