Pregnant Obese Women and Fetal Ultrasound Quality.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obese Women
- Pregnant Women
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: Scans will be evaluated by independent experts who had not performed the exams. Scans will be anonymized and ultrasound propagation velocity will not be reported on the images.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04212234
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Amélie Delabaere, MD, PhD CHU de Clermont-Ferrand
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