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

NCT03342014 | Completed

• 1 other identifier: 2017-A02418-45
• Study Type: interventional
• Target: 2,159
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (3)

• Measure of 3D power Doppler indice : the vascularization index (VI)

  through study completion, an average of 40 months

• Measure of 3D power Doppler indice : the flow index (FI)

  through study completion, an average of 40 months

• Measure of 3D power Doppler indice : the vascularization-flow index (VFI)

  through study completion, an average of 40 months

Study Arms (1)

All patients

EXPERIMENTAL

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

Device: Ultrasound; Biological: Blood sample collection

Interventions

Ultrasound DEVICE

3DPD and UAD acquisitions (10 min)

All patients

Blood sample collection BIOLOGICAL

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• 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.

  PMID: 33077562 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 14, 2017
• Study Start: April 16, 2018
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)