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First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography (SPIRIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342014
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Introduction: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to a chronic utero-placental hypoperfusion. Nowadays, there isn't a screening or diagnostic test in clinic for utero-placental vascularization deficiency. Since 2004, 3D Power Doppler 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). A high intra and inter-observer reproducibility and its potential interest for placental function study were reported. The investigator's main hypothesis is that these 3DPD indices could provide predictive values for PE and/or IUGR occurrence much higher than those observed with the currents other markers.

Objectives: The main objective of this study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women.

Methods and analysis: This is a prospective study. The investigators expect to include 2200 women in 3 French centers: CHRU of Nancy, Paris-APHP Port-Royal, and Strasbourg.

The nulliparous pregnant women will be recruited during their 1st trimester consultation for routine Down syndrome screening (11-13+6 GW). Especially for the study, the 3DPD and Uterine Artery Doppler (UAD) acquisition, which last less than 10 min, will be included in the current routine 11-13+6 GW ultrasound screening for Down syndrome. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Utero-placental vascularization indices (VI, FI, VFI) will be quantified using VOCAL® software. For each subgroup (uncomplicated pregnancy, PE and IUGR) mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Device: Ultrasound Biological: Blood sample collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography (SPIRIT): A Prospective Study in Nulliparous Pregnant Women
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients
All patients will have the same intervention (3DPD and UAD acquisitions ; blood sample)
Device: Ultrasound
3DPD and UAD acquisitions (10 min)

Biological: Blood sample collection
A blood sampling (20 mL) is collected for biomarker analysis (PAPP-A and PlGF) and biological collection.




Primary Outcome Measures :
  1. Measure of 3D power Doppler indice : the vascularization index (VI) [ Time Frame: through study completion, an average of 40 months ]
  2. Measure of 3D power Doppler indice : the flow index (FI) [ Time Frame: through study completion, an average of 40 months ]
  3. Measure of 3D power Doppler indice : the vascularization-flow index (VFI) [ Time Frame: through study completion, an average of 40 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton nulliparous pregnant women between 11 and 13+6 WG.
  • Mandatory enrolment in a social security plan,
  • Patient (or a third person, independent from the investigator and the sponsor, in case of inability to read or write) having signed an informed consent.

Exclusion Criteria:

  • Patients under a measure of legal protection.
  • Patient under 18,
  • Absence of social insurance,
  • Patient participating simultaneously to other interventional research trial to test a pharmaceutical treatment and protocols are not compatible,
  • Inability to understand and accept the protocol.

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): NCT03342014


Contacts
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Contact: Olivier MOREL +33.3.83.85.15.77 olivier.morel17@gmail.com
Contact: Claire BANASIAK +33.3.83.15.42.78 c.banasiak@chru-nancy.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Nancy Recruiting
Vandoeuvre-lès-Nancy, France, 54500
Contact: Charline Bertholdt       c.bertholdt@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03342014    
Other Study ID Numbers: 2017-A02418-45
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes