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

NCT ID: NCT03342014

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2022-11-14

Brief Summary

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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 4 French centers: Centre Hospitalier Universitaire de Nancy, Paris-Port-Royal (Assistance Publique - Hôpitaux de Paris), Strasbourg and Belfort (Hôpital Nord Franche-Comté).

The nulliparous pregnant women will be recruited during their 1st trimester consultation for routine Down syndrome screening (11-13+6 gestation weeks). 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 gestation weeks ultrasound screening. 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.

Detailed Description

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Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients

All patients will have the same intervention (3DPD and UAD acquisitions ; blood sample)

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

3DPD and UAD acquisitions (10 min)

Blood sample collection

Intervention Type BIOLOGICAL

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

Interventions

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Ultrasound

3DPD and UAD acquisitions (10 min)

Intervention Type DEVICE

Blood sample collection

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Singleton nulliparous pregnant women between 11 and 13+6 gestation weeks.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Olivier MOREL

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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Bertholdt C, Hossu G, Banasiak C, Beaumont M, Morel O. First trimester screening for pre-eclampsia and intrauterine growth restriction using three-dimensional Doppler angiography (SPIRIT): protocol for a multicentre prospective study in nulliparous pregnant women. BMJ Open. 2020 Oct 19;10(10):e037751. doi: 10.1136/bmjopen-2020-037751.

Reference Type DERIVED
PMID: 33077562 (View on PubMed)

Other Identifiers

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2017-A02418-45

Identifier Type: -

Identifier Source: org_study_id