Clinical trial NCT04639973: Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)
Official title: Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: pregnancy
fetal ultrasound
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Completion Rate for First Trimester Scans
timeFrame: 12-14 weeks of pregnancy
measure: Completion Rate for Second Trimester Scans
timeFrame: 18-22 weeks of pregnancy
Secondary outcomes:
measure: Completion Rate of First Trimester and Second Trimester Scans
timeFrame: 12-22 weeks of pregnancy
measure: Time Taken to Complete Scan in the First Trimester Ultrasound Group
timeFrame: 12-14 weeks of pregnancy
measure: Number of Anomalies Identified in First Trimester Group Scans
timeFrame: 12-14 weeks of pregnancy
measure: Number of Anomalies Identified in Second Trimester Group Scans
timeFrame: 12-22 weeks of pregnancy
measure: Number of Anomalies Missed in First Trimester Group Scans
timeFrame: 12-14 weeks of pregnancy
measure: Number of Anomalies Missed in Second Trimester Group Scans
timeFrame: 12-22 weeks of pregnancy
measure: Number of Participants With Infants Who Survive
timeFrame: 9 months from randomization
measure: Gestational Age at Delivery
timeFrame: at the time of delivery (about 40 weeks of pregnancy)
measure: Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)
timeFrame: at the time of NICU admission (about 0 to 28 days after birth)
measure: Hospital Length of Stay
timeFrame: from time of hospital admission to discharge (about 0 to 365 days after birth)
measure: Number of Participants With Infants With Neonatal Morbidities
timeFrame: 9 months from randomization
measure: Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans
timeFrame: 6 months from randomization
measure: Cost of Intervention Compared to Usual Care
timeFrame: from 12-22 weeks of pregnancy
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Cara Buskmiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buskmiller C, Fishel Bartal M, Bonilla M, Denham C, Nguyen R, Sibai B, Pedroza C, Hernandez-Andrade E. First trimester anatomy ultrasound for patients with obesity: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101143. doi: 10.1016/j.ajogmf.2023.101143. Epub 2023 Sep 3.
citation: Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. A Learning Curve for First-Trimester Anatomy Ultrasound in Obese Patients. Gynecol Obstet Invest. 2024;89(4):346-350. doi: 10.1159/000538477. Epub 2024 Mar 22.