|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Collaborator: |
GE Medical Systems ultrasound (only technical support) |
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00930397 |
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. |
| Estimated Enrollment: | 170 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | January 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.
|
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 |
100 women high risk of pre-eclampsia and 70 women low risk women of pre-eclampsia
Inclusion Criteria:
Group 1:
-Personal History of:
Group 2:Absence of all the Group 1 affiliation criteria.
Exclusion Criteria:
Contacts and Locations| Contact: Olivier MOREL, MD | (33) 6 88 22 31 40 | Olivier.morel17@wanadoo.fr |
| France | |
| Hôpital LARIBOISIERE Service de gynécologie- obstétrique | Recruiting |
| Paris, France, 75010 | |
| Contact: Olivier MOREL, MD (33) 6 88 22 31 40 Olivier.morel17@wanadoo.fr | |
| Principal Investigator: OIivier MOREL, MD | |
| Principal Investigator: | Olivier MOREL, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Mathieu QUINTIN, Department of clinical research and development |
| ClinicalTrials.gov Identifier: | NCT00930397 History of Changes |
| Other Study ID Numbers: | CRC 07049 |
| Study First Received: | June 29, 2009 |
| Last Updated: | September 29, 2009 |
| Health Authority: | France: Ministry of Health |
|
Pre-eclampsia UTERO-placental unit vascularization Hypertension, pregnancy- induced |
IUGR Screening 3D Doppler Ultrasound |
|
Eclampsia Fetal Growth Retardation Placental Insufficiency Pre-Eclampsia Hypertension, Pregnancy-Induced |
Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Placenta Diseases |
