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

NCT02302573 | Completed

• 1 other identifier: PHRI08-FP : Placenta Accreta
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Placenta Accreta

Keywords

placenta accreta; contrast-enhanced unltrasound; pregnancy; MRI; sonovue

Outcome Measures

Primary Outcomes (1)

• Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta

  up to 9 months after consent

Secondary Outcomes (1)

• depth of infiltration placenta measured by CEUS

  up to 9 months after consent

Study Arms (1)

placenta accreta

EXPERIMENTAL

contast-enhanced ultrasound with sonovue

Drug: contast-enhanced ultrasound with sonovue

Interventions

contast-enhanced ultrasound with sonovue DRUG

contast-enhanced ultrasound with sonovue

Also known as: Sonovue® (Bracco, Milan, Italie)

placenta accreta

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

CHU La Millétrie

Poitiers, 86000, France

Location

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (1)

• Denis de Senneville B, Novell A, Arthuis C, Mendes V, Dujardin PA, Patat F, Bouakaz A, Escoffre JM, Perrotin F. Development of a Fluid Dynamic Model for Quantitative Contrast-Enhanced Ultrasound Imaging. IEEE Trans Med Imaging. 2018 Feb;37(2):372-383. doi: 10.1109/TMI.2017.2743099. Epub 2017 Aug 29.

  PMID: 28858788 RESULT

MeSH Terms

Conditions

Placenta Accreta

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Franck Perrotin, MD

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 27, 2014
• Study Start: May 1, 2009
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 26, 2025

Record last verified: 2016-12

Locations

FR (2)