Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies
EVUPA
1 other identifier
interventional
112
1 country
1
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pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)).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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedJuly 7, 2016
July 1, 2016
3.1 years
June 30, 2016
July 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Measure of 3D power Doppler indice : the vascularization index (VI)
through study completion, an average of 42 month
Measure of 3D power Doppler indice : blood flow (the flow index (FI)
through study completion, an average of 42 month
Measure of of 3D power Doppler indice : the vascularization-flow index (VFI)
through study completion, an average of 42 month
Measure of volume density (morphological analysis)
through study completion, an average of 42 month
Measure of surface density (morphological analysis)
through study completion, an average of 42 month
Study Arms (2)
pathological group
OTHERpregnant women with preeclampsia and/or IUGR pregnancy with a planned or semi-urgent caesarean section or vaginal delivery will be recruited into this study.
physiological group
OTHERpregnant women with normal pregnancy with a planned caesarean section or vaginal delivery will be recruited into this study
Interventions
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
Eligibility Criteria
You may qualify if:
- Age ≥18 years and ≤65 years Fetal anomalies
- Gestational age ≥30 gestational weeks
- With social insurance
- With written consent for participation
- With medical examination
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pr Olivier MOREL
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
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.
PMID: 27033959BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier MOREL, MD, PhD
Inserm U947, IADI, Nancy, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 7, 2016
Study Start
December 1, 2013
Primary Completion
January 1, 2017
Last Updated
July 7, 2016
Record last verified: 2016-07