Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy (PLACENTA3D)
Pre-eclampsia and intra uterine growth restriction (IUGR) represent major complications for pregnant women, with a high related maternal and fetal morbidity and mortality. It is now widely admitted that these pathologies, which can concern up to 7% of pregnancies, are in relation with hypo-perfusion of the placenta because of an early deficient trophoblast invasion and uterine vascular remodelling.Advances in ultrasound imaging now permit non invasive 3D volume and Doppler signal quantification using automatic acquisitions.Quantitative comparison of volumes and Doppler parameters between control pregnancies and IUGR ought to confirm the theory of UTERO-placental hypo-perfusion. This technique might allow an earlier prediction for IUGR. The aim of this study is to evaluate the interest of 3D Doppler quantification as a new screening tool for pre eclampsia and IUGR.
Intra-uterine Growth Restriction
3D Doppler Ultrasound.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Evaluation of UTERO - Placental 3D Doppler Examination Potential Interest for Pre- Eclampsia Screening During Pregnancy. Observational Study in 100 Women at High Risk for Pre- Eclampsia and 70 Low Risk Women.|
- Existence of pre eclampsia and/or IUGR [ Time Frame: at the end of the pregnancy ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Low risk women
Women without any personal risk.
High risk women
Women at high risk for pre-eclampsia with personal of pre-eclampsia and/or IUGR in a previous pregnancy, diabetes, auto-immune syndrome such as lupus, hypertension, renal insufficiency and anti-phospholipid.
One hundred high risk women and 70 low risk women will be included. Inclusion criteria for the high risk group are: personal history of pre eclampsia and/or IUGR in a previous pregnancy, diabetes, auto-immune syndrome such as LUPUS, hypertension, renal insufficiency, and anti-phospholipid syndrome.Patients (over 18 years old) will be included between 11 and 14(+6days) WG. Only singletons pregnancies will be included.3D Doppler standardized acquisitions of the UTERO-placental unit will be performed at each usual ultrasound examination of the pregnancy.Data will be analysed after delivery, in terms of quantified Doppler values, comparing two groups: pregnancies with pre eclampsia / IUGR (group with pathology) and normal pregnancies (control group).This is an observational study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930397
|Hôpital LARIBOISIERE Service de gynécologie- obstétrique|
|Paris, France, 75010|
|Principal Investigator:||Olivier MOREL, MD||Assistance Publique - Hôpitaux de Paris|