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

NCT00930397 | Completed

• 1 other identifier: CRC 07049
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Pre-eclampsia; UTERO-placental unit vascularization; Hypertension, pregnancy- induced; IUGR; Screening; 3D Doppler Ultrasound

Outcome Measures

Primary Outcomes (1)

• Existence of pre eclampsia and/or IUGR

  at the end of the pregnancy

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Participating in the study
• Unability to understand the study
• Set back of patient consent.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• GE Medical Systems ultrasound (only technical support): collaborator

Study Sites (1)

Hôpital LARIBOISIERE Service de gynécologie- obstétrique

Paris, 75010, France

Location

MeSH Terms

Conditions

Pre-Eclampsia; Placental Insufficiency; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier MOREL, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 16, 2020

Record last verified: 2013-05

Locations

FR (1)