Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies (EVUPA)
Primary Purpose
Preeclampsia, Intra-uterine Growth Restriction
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Doppler
Sponsored by
About this trial
This is an interventional basic science trial for Preeclampsia focused on measuring 3D Power Doppler, uteroplacental vascularization, preeclampsia, intra-uterine growth restriction, placental morphology
Eligibility Criteria
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
Sites / Locations
- Pr Olivier MORELRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
pathological group
physiological group
Arm Description
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.
pregnant women with normal pregnancy with a planned caesarean section or vaginal delivery will be recruited into this study
Outcomes
Primary Outcome Measures
Measure of 3D power Doppler indice : the vascularization index (VI)
Measure of 3D power Doppler indice : blood flow (the flow index (FI)
Measure of of 3D power Doppler indice : the vascularization-flow index (VFI)
Measure of volume density (morphological analysis)
Measure of surface density (morphological analysis)
Secondary Outcome Measures
Full Information
NCT ID
NCT02825277
First Posted
June 30, 2016
Last Updated
July 4, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02825277
Brief Title
Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies
Acronym
EVUPA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Intra-uterine Growth Restriction
Keywords
3D Power Doppler, uteroplacental vascularization, preeclampsia, intra-uterine growth restriction, placental morphology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pathological group
Arm Type
Other
Arm Description
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.
Arm Title
physiological group
Arm Type
Other
Arm Description
pregnant women with normal pregnancy with a planned caesarean section or vaginal delivery will be recruited into this study
Intervention Type
Device
Intervention Name(s)
Doppler
Intervention Description
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
Primary Outcome Measure Information:
Title
Measure of 3D power Doppler indice : the vascularization index (VI)
Time Frame
through study completion, an average of 42 month
Title
Measure of 3D power Doppler indice : blood flow (the flow index (FI)
Time Frame
through study completion, an average of 42 month
Title
Measure of of 3D power Doppler indice : the vascularization-flow index (VFI)
Time Frame
through study completion, an average of 42 month
Title
Measure of volume density (morphological analysis)
Time Frame
through study completion, an average of 42 month
Title
Measure of surface density (morphological analysis)
Time Frame
through study completion, an average of 42 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier MOREL, MD, PhD
Email
olivier.morel17@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aboubaker CHIRIFI
Email
a.cherifi@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MOREL, MD, PhD
Organizational Affiliation
Inserm U947, IADI, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr Olivier MOREL
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MOREL
12. IPD Sharing Statement
Citations:
PubMed Identifier
27033959
Citation
Duan J, Chabot-Lecoanet AC, Perdriolle-Galet E, Christov C, Hossu G, Cherifi A, Morel O. 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 (EVUPA): a prospective controlled study. BMJ Open. 2016 Mar 31;6(3):e009909. doi: 10.1136/bmjopen-2015-009909.
Results Reference
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Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies
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