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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930397
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : May 27, 2013
GE Medical Systems ultrasound (only technical support)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

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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

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930397

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Hôpital LARIBOISIERE Service de gynécologie- obstétrique
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GE Medical Systems ultrasound (only technical support)
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Principal Investigator: Olivier MOREL, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00930397    
Other Study ID Numbers: CRC 07049
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
UTERO-placental unit vascularization
Hypertension, pregnancy- induced
3D Doppler Ultrasound
Additional relevant MeSH terms:
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Placental Insufficiency
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Placenta Diseases
Fetal Diseases
Growth Disorders
Pathologic Processes