Clinical Trial: Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population

Brief Summary:

Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part or the entire chorionic plate with penetration of chorionic villi in the myometrium and absence of the decidua basalis. This anomaly is associated with significant maternal morbidity and mortality as it may result in severe haemorrhage during the post-partum. It has been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal morbidity. In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to better outcomes, due to fewer emergency operations and less mass transfusions. Currently, the diagnosis of AIP is based on a combination of conventional B-mode ultrasound and MRI. However, prenatal diagnosis of AIP remains challenging and recent reports demonstrated it is achieved in only thirds of cases.

Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular rheological properties of these bubbles are similar to those of red blood cells and they remain entirely within the intravascular space. Previous studies have demonstrated that microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet approved for clinical use, CEUS offers the opportunity to analyze anatomical placental landmarks, improving the contrast between placenta and myometrium. In addition, quantification parameters related to the contrast enhancement have been proposed as objective indicators to estimate blood perfusion rates in the placental intervillous space.

The main objective of this study is to provide pre-clinical evaluation of CEUS for the diagnosis of AIP and to try to determine if AIP are charact

Detailed Summary:
Sponsor: University Hospital, Tours

Current Primary Outcome: Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta [ Time Frame: up to 9 months after consent ]

Original Primary Outcome: Same as current

Current Secondary Outcome: depth of infiltration placenta measured by CEUS [ Time Frame: up to 9 months after consent ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Tours

Dates:
Date Received: November 14, 2014
Date Started: May 2009
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016