Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy (PLACENTA3D)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Pre-eclampsia; Intra-uterine Growth Restriction; Placental Insufficiency; 3D Doppler Ultrasound.

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	146 participants
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.
Study Start Date :	July 2009
Actual Primary Completion Date :	November 2011
Actual Study Completion Date :	November 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.

Outcome Measures

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Primary Outcome Measures :

1. Existence of pre eclampsia and/or IUGR [ Time Frame: at the end of the pregnancy ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

100 women high risk of pre-eclampsia and 70 women low risk women of pre-eclampsia

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Hôpital LARIBOISIERE Service de gynécologie- obstétrique
Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

GE Medical Systems ultrasound (only technical support)

Investigators

Principal Investigator:	Olivier MOREL, MD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00930397 History of Changes
Other Study ID Numbers:	CRC 07049
First Posted:	June 30, 2009
Last Update Posted:	May 27, 2013
Last Verified:	May 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Additional relevant MeSH terms:

Eclampsia; Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency; Hypertension, Pregnancy-Induced	Pregnancy Complications; Fetal Diseases; Growth Disorders; Pathologic Processes; Placenta Diseases