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

July 4, 2016 updated by: Central Hospital, Nancy, France

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and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)).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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy, France, 54511
        • Recruiting
        • Pr Olivier MOREL
        • Contact:
          • Olivier MOREL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: Doppler
acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
Other: physiological group
pregnant women with normal pregnancy with a planned caesarean section or vaginal delivery will be recruited into this study
Device: Doppler
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Olivier MOREL, MD, PhD, Inserm U947, IADI, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

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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