NCT04639973

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

Completed NA Results posted Last updated 21 May 2024

What this trial tests

NA trial testing Group 1 (First trimester ultrasound) in Obesity in 128 participants. Completed in 21 November 2022.

Timeline

1 February 2021

Primary endpoint
30 April 2022

21 November 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	128
Start date	1 February 2021
Primary completion	30 April 2022
Estimated completion	21 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Group 1 (First trimester ultrasound)
• Group 2 (Second trimester anatomy ultrasound)

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 50, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Completion Rate for First Trimester Scans Primary · 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

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	66

Completion Rate for Second Trimester Scans Primary · 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.

Group	Value	95% CI
Group 2 (Second Trimester Anatomy Ultrasound)	53

Completion Rate of First Trimester and Second Trimester Scans Secondary · 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).

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	82.8

Time Taken to Complete Scan in the First Trimester Ultrasound Group Secondary · 12-14 weeks of pregnancy

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	65	± 27

Number of Anomalies Identified in First Trimester Group Scans Secondary · 12-14 weeks of pregnancy

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	5

Number of Anomalies Identified in Second Trimester Group Scans Secondary · 12-22 weeks of pregnancy

Group	Value	95% CI
Group 2 (Second Trimester Anatomy Ultrasound)	6

Number of Anomalies Missed in First Trimester Group Scans Secondary · 12-14 weeks of pregnancy

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	3

Number of Anomalies Missed in Second Trimester Group Scans Secondary · 12-22 weeks of pregnancy

Group	Value	95% CI
Group 2 (Second Trimester Anatomy Ultrasound)	0

Number of Participants With Infants Who Survive Secondary · 9 months from randomization

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	57
Group 2 (Second Trimester Anatomy Ultrasound)	60

Gestational Age at Delivery Secondary · at the time of delivery (about 40 weeks of pregnancy)

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	37.4	34.9 – 38.9
Group 2 (Second Trimester Anatomy Ultrasound)	37.5	36.7 – 38.9

Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) Secondary · at the time of NICU admission (about 0 to 28 days after birth)

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	18
Group 2 (Second Trimester Anatomy Ultrasound)	8

Hospital Length of Stay Secondary · from time of hospital admission to discharge (about 0 to 365 days after birth)

Group	Value	95% CI
Group 1 (First Trimester Ultrasound)	8	4.5 – 16.5
Group 2 (Second Trimester Anatomy Ultrasound)	18	8.5 – 25.5

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of enrollment until neonatal discharge from hospital (from about 12 weeks of pregnancy to 365 days after birth). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1 (First Trimester Ultrasound)

Serious: 5/64 (8%)

Deaths: 0/64

Group 2 (Second Trimester Anatomy Ultrasound)

Serious: 1/63 (2%)

Deaths: 0/63

Serious adverse events (3 terms)

Reaction	System	Group 1 (First Trimester U…	Group 2 (Second Trimester …
Miscarriage	Pregnancy, puerperium and perinatal conditions	—	—
Fetal death	Pregnancy, puerperium and perinatal conditions	—	—
Neonatal death	Pregnancy, puerperium and perinatal conditions	—	—

Most-reported serious reactions: Miscarriage, Fetal death, Neonatal death.

Data from ClinicalTrials.gov NCT04639973 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Learning Curve for First-Trimester Anatomy Ultrasound in Obese Patients.
   Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. · · 2024 · PMID 38522420 · DOI 10.1159/000538477