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

Primary Purpose

Placenta Accreta

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
contast-enhanced ultrasound with sonovue
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Accreta focused on measuring placenta accreta, contrast-enhanced unltrasound, pregnancy, MRI, sonovue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Tours
  • CHU La Millétrie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

placenta accreta

Arm Description

contast-enhanced ultrasound with sonovue

Outcomes

Primary Outcome Measures

Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta

Secondary Outcome Measures

depth of infiltration placenta measured by CEUS

Full Information

First Posted
November 14, 2014
Last Updated
December 5, 2016
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02302573
Brief Title
Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population
Official Title
Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
Keywords
placenta accreta, contrast-enhanced unltrasound, pregnancy, MRI, sonovue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placenta accreta
Arm Type
Experimental
Arm Description
contast-enhanced ultrasound with sonovue
Intervention Type
Drug
Intervention Name(s)
contast-enhanced ultrasound with sonovue
Other Intervention Name(s)
Sonovue® (Bracco, Milan, Italie)
Intervention Description
contast-enhanced ultrasound with sonovue
Primary Outcome Measure Information:
Title
Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta
Time Frame
up to 9 months after consent
Secondary Outcome Measure Information:
Title
depth of infiltration placenta measured by CEUS
Time Frame
up to 9 months after consent

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Perrotin, MD
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU La Millétrie
City
¨Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

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