Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy (PLACENTA3D)
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ClinicalTrials.gov Identifier: NCT00930397 |
Recruitment Status
:
Completed
First Posted
: June 30, 2009
Last Update Posted
: May 27, 2013
|
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Condition or disease |
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Pre-eclampsia Intra-uterine Growth Restriction Placental Insufficiency 3D Doppler Ultrasound. |
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 |

Group/Cohort |
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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.
|
- Existence of pre eclampsia and/or IUGR [ Time Frame: at the end of the pregnancy ]

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

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 ClinicalTrials.gov identifier (NCT number): NCT00930397
France | |
Hôpital LARIBOISIERE Service de gynécologie- obstétrique | |
Paris, France, 75010 |
Principal Investigator: | Olivier MOREL, MD | Assistance Publique - Hôpitaux de Paris |
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 Key Record Dates |
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 |