First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography (SPIRIT)
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|ClinicalTrials.gov Identifier: NCT03342014|
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : July 30, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: All patients
All patients will have the same intervention (3DPD and UAD acquisitions ; blood sample)
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.
- Measure of 3D power Doppler indice : the vascularization index (VI) [ Time Frame: through study completion, an average of 40 months ]
- Measure of 3D power Doppler indice : the flow index (FI) [ Time Frame: through study completion, an average of 40 months ]
- Measure of 3D power Doppler indice : the vascularization-flow index (VFI) [ Time Frame: through study completion, an average of 40 months ]
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
|Contact: Olivier MORELemail@example.com|
|Contact: Claire BANASIAKfirstname.lastname@example.org|
|Centre Hospitalier Régional Universitaire de Nancy||Recruiting|
|Vandoeuvre-lès-Nancy, France, 54500|
|Contact: Charline Bertholdt email@example.com|