Clinical trial NCT00930397: Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-eclampsia
Intra-uterine Growth Restriction
Placental Insufficiency
3D Doppler Ultrasound
Keywords: Pre-eclampsia
UTERO-placental unit vascularization
Hypertension, pregnancy- induced
IUGR
Screening
3D Doppler Ultrasound
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GE Medical Systems ultrasound (only technical support)
First posted: 2009-06-30
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 women high risk of pre-eclampsia and 70 women low risk women of pre-eclampsia

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age eligible for study up to 18 years
* Gestational age between 11 to 14 weeks for the first visit (first-trimester pregnancy).-Singleton pregnancy
* Consent to participate in the study
* Patients affiliated to social security

Group 1:

-Personal History of:

* Preeclampsia during a previous pregnancy: Blood pressure more than 140 mmHg systolic and/or 90 mmHg diastolic + proteinuria
* Diabetes
* IUGR during a previous pregnancy (birth weight \< 10th centile)
* Hypertension
* Renal insufficiency
* Autoimmune Disease : Antiphospholipid syndrome

Group 2:Absence of all the Group 1 affiliation criteria.

Exclusion Criteria:

* Participating in the study
* Unability to understand the study
* Set back of patient consent.

Primary outcomes:
measure: Existence of pre eclampsia and/or IUGR
timeFrame: at the end of the pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital LARIBOISIERE Service de gynécologie- obstétrique
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier MOREL, MD
role: PRINCIPAL_INVESTIGATOR
References: