- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825277
Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies (EVUPA)
Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies: Third Trimester Quantification Using 3D Power Doppler With Comparison to Placental Vascular Morphology
Introduction
Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy complications related to chronic utero-placental hypoperfusion. Three-dimensional power Doppler (3DPD) angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints hinder the clinical use of 3DPD as physical characteristics and machine settings may affect 3DPD indices, and so its clinical significance is not yet clear.
Objectives
The primary objective is to better understand the clinical significance of 3DPD indices by evaluating the relationship between these indices and placental morphometry. Secondary objectives are (i) to determine the impact of machine settings and physical characteristics on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.
Methods and analysis
This is a prospective controlled study. We expect to include 112 women: 84 with normal pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent caesarean section, utero-placental 3DPD images with five different machine settings will be acquired. Placentas will be collected and examined after surgery and stereological indices (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between 3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a multivariate linear regression model.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier MOREL, MD, PhD
- Email: olivier.morel17@gmail.com
Study Contact Backup
- Name: Aboubaker CHIRIFI
- Email: a.cherifi@chru-nancy.fr
Study Locations
-
-
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Vandoeuvre les Nancy, France, 54511
- Recruiting
- Pr Olivier MOREL
-
Contact:
- Olivier MOREL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion Criteria:
- Age ≥18 years and ≤65 years Fetal anomalies
- Gestational age ≥30 gestational weeks
- With social insurance
- With written consent for participation
- With medical examination
Physiological group Inclusion Criteria
- Hospitalised pregnant women with scheduled or semi-urgent caesarean section according to national HAS recommendations or Hospitalised pregnant women with scheduled vaginal delivery.
- Normal pregnancy issues
- Normal fetal morphology
Pathological group Inclusion Criteria
- Pregnant women with preeclampsia and/or IUGR pregnancy
- Hospitalised pregnant women with scheduled or semi-urgent caesarean section or hospitalised pregnant women with scheduled vaginal delivery.
Exclusion Criteria:
- Fetal morphological abnormalities that may influence fetal circulation
- Maternal or fetal vital urgency
- Multiple pregnancy
- Non-placental origin IUGR
- Language barrier
- Patient under legal protection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: pathological group
pregnant women with preeclampsia and/or IUGR pregnancy with a planned or semi-urgent caesarean section or vaginal delivery will be recruited into this study.
|
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
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Other: physiological group
pregnant women with normal pregnancy with a planned caesarean section or vaginal delivery will be recruited into this study
|
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of 3D power Doppler indice : the vascularization index (VI)
Time Frame: through study completion, an average of 42 month
|
through study completion, an average of 42 month
|
Measure of 3D power Doppler indice : blood flow (the flow index (FI)
Time Frame: through study completion, an average of 42 month
|
through study completion, an average of 42 month
|
Measure of of 3D power Doppler indice : the vascularization-flow index (VFI)
Time Frame: through study completion, an average of 42 month
|
through study completion, an average of 42 month
|
Measure of volume density (morphological analysis)
Time Frame: through study completion, an average of 42 month
|
through study completion, an average of 42 month
|
Measure of surface density (morphological analysis)
Time Frame: through study completion, an average of 42 month
|
through study completion, an average of 42 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier MOREL, MD, PhD, Inserm U947, IADI, Nancy, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A01049-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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