Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00930397

Acronym

PLACENTA3D

Enrollment

146

Registered

2009-06-30

Start date

2009-07-31

Completion date

2011-11-30

Last updated

2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3D Doppler Ultrasound, Intra-uterine Growth Restriction, Placental Insufficiency, Pre-eclampsia

Keywords

Pre-eclampsia, UTERO-placental unit vascularization, Hypertension, pregnancy- induced, IUGR, Screening, 3D Doppler Ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Existence of pre eclampsia and/or IUGR	at the end of the pregnancy

Countries

France

Outcome results