Skip to main content
OpenTrials
Completed

NCT Number: NCT02302573

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

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 characterised by differences in intervillous blood rheological properties. Conventional CEUS parameters will be: rise time, peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.

As this study is a pre-clinical evaluation, sample size calculation remains subjective and imprecise. For this reason, a sample size of 100 pregnant women to be included in this prospective study has been decided.

The potential impact of this study will be to propose a more reliable tool with both improved sensibility and specificity compared to the combination US/MRI and therefore to reduce the maternal worldwide burden of AIP.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU La Millétrie, Poitiers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant patient having any of the following two conditions:
  • Scar uterus (previous cesarean) with placenta previa partly or wholly on the uterine scar
  • Placenta praevia and patient aged over 35 years
  • Term > 34 weeks of amenorrhea
  • More than 18 years old
  • Inform consent form signed
  • affiliated to medical insurrance

Exclusion criteria

  • Inability to understand information
  • Contraindications to the contrast medium Sonovue:
  • Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue
  • Recent acute coronary syndrome (within 6 months before the intervention)
  • Unstable ischemic heart disease (myocardial infarction being formed or evolving, typical angina of rest in the previous month)
  • Significant worsening of cardiac symptoms between the pre anaesthesia consultation and intervention
  • Recent intervention (less than 6 months) on coronary arteries or other factor suggesting clinical instability (changes in ECG, changes in clinical or biological parameters)
  • Acute heart failure or heart failure stage III or IV
  • Severe arrhythmias
  • Right-left shunt
  • Acute endocarditis
  • Valve prothesis
  • Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
  • Systemic hypertension uncontrolled
  • Respiratory distress syndrome

Treatment and study plan

contast-enhanced ultrasound with sonovue

Drug

contast-enhanced ultrasound with sonovue

Other names: Sonovue® (Bracco, Milan, Italie)

Primary outcomes

  1. Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta

    Time frame: up to 9 months after consent

Secondary outcomes

  1. depth of infiltration placenta measured by CEUS

    Time frame: up to 9 months after consent

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.