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

Pre-eclampsia Clinical Trial

— PLACENTA3D  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930397
• Other study ID #: CRC 07049
• Status: Completed
• Start date: July 2009
• Est. completion date: November 2011

Study information

• Verified date: May 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 3D Doppler Ultrasound
• Eclampsia
• Fetal Growth Retardation
• Intra-uterine Growth Restriction
• Placental Insufficiency
• Pre-Eclampsia

Locations

Country	Name	City	State
France	Hôpital LARIBOISIERE Service de gynécologie- obstétrique	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GE Medical Systems ultrasound (only technical support)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of pre eclampsia and/or IUGR		at the end of the pregnancy