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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
History of Changes
  Purpose

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
Pre-eclampsia
Intra-uterine Growth Restriction
Placental Insufficiency
3D Doppler Ultrasound.

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Existence of pre eclampsia and/or IUGR [ Time Frame: at the end of the pregnancy ] [ Designated as safety issue: No ]
Enrollment: 146
Study Start Date: July 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930397

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00930397     History of Changes
Other Study ID Numbers: CRC 07049
Study First Received: June 29, 2009
Last Updated: May 24, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on February 27, 2015