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

This study has been completed.
Sponsor:
Collaborator:
GE Medical Systems ultrasound (only technical support)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00930397
First received: June 29, 2009
Last updated: May 24, 2013
Last verified: May 2013

June 29, 2009
May 24, 2013
July 2009
November 2011   (final data collection date for primary outcome measure)
Existence of pre eclampsia and/or IUGR [ Time Frame: at the end of the pregnancy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930397 on ClinicalTrials.gov Archive Site
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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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Pre-eclampsia
  • Intra-uterine Growth Restriction
  • Placental Insufficiency
  • 3D Doppler Ultrasound.
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00930397
CRC 07049
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
GE Medical Systems ultrasound (only technical support)
Principal Investigator: Olivier MOREL, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP