Pregnant Obese Women and Fetal Ultrasound Quality. (EPOWUS)
Echography in Pregnant Obese Women and Ultrasound Speed.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obese pregnant women will be included before the second trimester fetal ultrasound examination.
Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
In the control group, exam will be performed using the conventional ultrasound velocity.
An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
-
Lyon, France
- Hôpital de la croix Rousse - Hospices Civils de Lyon
-
Lyon, France
- Hôpital Femme Mére Enfant - Hospices Civils de Lyon
-
Montpellier, France
- Hôpital Arnaud de Villeneuve - CHU de Montpellier
-
Paris, France
- Hôpital Cochin - Assistance Publique - Hôpitaux de Paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index>30
- Between 20 and 25 weeks of gestation
Exclusion Criteria:
- Multiple pregnancy
- Uterine scare
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: free ultrasound propagation velocity
ultrasound exams will be performed using several ultrasound propagation velocities
|
Obese pregnant women will be included before the second trimester fetal ultrasound examination. Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam. In the control group, exam will be performed using the conventional ultrasound velocity. An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached. The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline. All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al. |
|
No Intervention: conventional ultrasound propagation velocity
ultrasound exams will be performed using the 1540m/s conventional celerity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
image quality of fetal ultrasound exam
Time Frame: second trimester and third trimester ultrasound exam
|
Quality will be assessed by calculating Salomon's score for each image.
|
second trimester and third trimester ultrasound exam
|
|
completeness of fetal ultrasound exam
Time Frame: second trimester and third trimester ultrasound exam
|
completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.
|
second trimester and third trimester ultrasound exam
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
use of supplementary ultrasound exams in order to assess completeness
Time Frame: through study completion, an average of 1 year
|
description of each modality of supplemental ultrasound exam
|
through study completion, an average of 1 year
|
|
description of ultrasonographist method in order to improve ultrasound exam
Time Frame: through study completion, an average of 1 year
|
description of modality
|
through study completion, an average of 1 year
|
|
economic analysis of the intervention
Time Frame: through study completion, an average of 1 year
|
cost-effectiveness analysis
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amélie Delabaere, MD, PhD, CHU de Clermont-Ferrand
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC IR 2018 DELABAERE
- 2018-A03478-47 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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