Status:
COMPLETED
Observational Study in UTERO - Placental 3D Doppler Examination: Interest for Pre-eclampsia Screening During Pregnancy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
GE Medical Systems ultrasound (only technical support)
Conditions:
Pre-eclampsia
Intra-uterine Growth Restriction
Eligibility:
FEMALE
18+ years
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 th...
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, aut...
Eligibility Criteria
Inclusion
- 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
- Participating in the study
- Unability to understand the study
- Set back of patient consent.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00930397
Start Date
July 1 2009
End Date
November 1 2011
Last Update
December 16 2020
Active Locations (1)
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1
Hôpital LARIBOISIERE Service de gynécologie- obstétrique
Paris, France, 75010