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

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ClinicalTrials.gov Identifier: NCT02825277
Recruitment Status : Unknown
Verified July 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)).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


Condition or disease Intervention/treatment Phase
Preeclampsia Intra-uterine Growth Restriction Device: Doppler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : December 2013
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Measure of 3D power Doppler indice : the vascularization index (VI) [ Time Frame: through study completion, an average of 42 month ]
  2. Measure of 3D power Doppler indice : blood flow (the flow index (FI) [ Time Frame: through study completion, an average of 42 month ]
  3. Measure of of 3D power Doppler indice : the vascularization-flow index (VFI) [ Time Frame: through study completion, an average of 42 month ]
  4. Measure of volume density (morphological analysis) [ Time Frame: through study completion, an average of 42 month ]
  5. Measure of surface density (morphological analysis) [ Time Frame: through study completion, an average of 42 month ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825277


Contacts
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Contact: Olivier MOREL, MD, PhD olivier.morel17@gmail.com
Contact: Aboubaker CHIRIFI a.cherifi@chru-nancy.fr

Locations
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France
Pr Olivier MOREL Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Olivier MOREL         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Olivier MOREL, MD, PhD Inserm U947, IADI, Nancy, France
Publications:
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02825277    
Other Study ID Numbers: 2013-A01049-36
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Keywords provided by Central Hospital, Nancy, France:
3D Power Doppler
uteroplacental vascularization
preeclampsia
intra-uterine growth restriction
placental morphology
Additional relevant MeSH terms:
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Pre-Eclampsia
Fetal Growth Retardation
Neovascularization, Pathologic
Hypertension, Pregnancy-Induced
Pregnancy Complications
Metaplasia
Pathologic Processes
Fetal Diseases
Growth Disorders