Placenta AccretaNCT02302573
Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population
A study testing contast-enhanced ultrasound with sonovue in people with Placenta Accreta, run by University Hospital, Tours at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- contast-enhanced ultrasound with sonovue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- May 2009to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU La Millétrie
Poitiers, 86000
University Hospital of Tours
Tours, 37044
About this study
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.
Read more
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
- Being tested
- contast-enhanced ultrasound with sonovue
- Keywords
- placenta accreta, contrast-enhanced unltrasound, pregnancy, MRI, sonovue
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contast-enhanced ultrasound with sonovueDrug
Also called Sonovue® (Bracco, Milan, Italie)
contast-enhanced ultrasound with sonovue
| Study group | Role | What they receive |
|---|---|---|
| placenta accreta | Experimental | contast-enhanced ultrasound with sonovue Receives: Drug: contast-enhanced ultrasound with sonovue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta
Measured: up to 9 months after consent
Secondary outcomes (1)
depth of infiltration placenta measured by CEUS
Measured: up to 9 months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startMay 2009
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Perrotin, MD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302573
- Sponsor's protocol ID
- PHRI08-FP : Placenta Accreta
- Status last verified
- Dec 2016
- First submitted
- 14 Nov 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28858788
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population
- ClinicalTrials.gov ID
- NCT02302573
- Acronym / sponsor ID
- PHRI08-FP : Placenta Accreta
- Conditions
- Placenta Accreta
- Keywords
- placenta accreta, contrast-enhanced unltrasound, pregnancy, MRI, sonovue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placenta accreta | Experimental | Drug: contast-enhanced ultrasound with sonovuecontast-enhanced ultrasound with sonovue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant patient having any of the following two conditions:
- Term > 34 weeks of amenorrhea
- More than 18 years old
- Inform consent form signed
- affiliated to medical insurrance
Key exclusion criteria (15 listed)
- Inability to understand information
- Contraindications to the contrast medium Sonovue:
- Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contast-enhanced ultrasound with sonovueAlso: Sonovue® (Bracco, Milan, Italie)contast-enhanced ultrasound with sonovue | Drug | placenta accreta |
Primary outcome
Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta
Time frame: up to 9 months after consent
1 secondary outcome
depth of infiltration placenta measured by CEUS
Time frame: up to 9 months after consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 28858788Denis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Perrotin, MD principal investigator
University Hospital of Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contast-enhanced ultrasound with sonovue in people with Placenta Accreta, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conventional contrast enhanced ultrasound parameters for diagnosing placenta accreta (time frame: up to 9 months after consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.