Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies

Preeclampsia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02825277
• Other study ID #: 2013-A01049-36
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2016
• Last updated: July 4, 2016
• Start date: December 2013

Study information

• Verified date: July 2016
• Source: Central Hospital, Nancy, France
• Contact: Olivier MOREL, MD, PhD
• Email: olivier.morel17[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)).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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intra-uterine Growth Restriction
• Neovascularization, Pathologic
• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Doppler
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta

Locations

Country	Name	City	State
France	Pr Olivier MOREL	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of 3D power Doppler indice : the vascularization index (VI)		through study completion, an average of 42 month	No
Primary	Measure of 3D power Doppler indice : blood flow (the flow index (FI)		through study completion, an average of 42 month	No
Primary	Measure of of 3D power Doppler indice : the vascularization-flow index (VFI)		through study completion, an average of 42 month	No
Primary	Measure of volume density (morphological analysis)		through study completion, an average of 42 month	No
Primary	Measure of surface density (morphological analysis)		through study completion, an average of 42 month	No