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CompletedNCT00930397PLACENTA3DUpdated Dec 16, 2020

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

An observational study in Pre-eclampsia, Intra-uterine Growth Restriction and Placental Insufficiency, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • 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
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In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's enrollment of 146 is close to the median of 158 across 146 observational studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Participating in the study
  • Unability to understand the study
  • Set back of patient consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Existence of pre eclampsia and/or IUGR

    Time frame: at the end of the pregnancy

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Study locations

1 site
  • Hôpital LARIBOISIERE Service de gynécologie- obstétrique
    Paris, 75010, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00930397
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GE Medical Systems ultrasound (only technical support)
Responsible party
Sponsor
First posted
Jun 30, 2009
Start date
Jul 2009
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Dec 16, 2020

Study contacts

Olivier MOREL, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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