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HexafluOride, a Contrast Agent for Placenta Echo-angiography (HOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884297
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
The purpose of this study is to quantify the placental perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography without a contrast agent and by ultrasound with a contrast agent: SonoVue®

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Contrast agent: SonoVue®. Phase 3

Detailed Description:

The quality of the utero-placental vascularization is a major point for the foetal healthy development and for the healthy pregnancy. Pre-eclampsia (PE) and the Intra-Uterine Growth Retardation (IUGR) are currently two of the major pregnancy complications in the West. Those placental pathologies cause more than 30 per cent of the foetal and maternal morbidity-mortality. The relationship between these pathologies, affecting 4 to 7 per cent of pregnancies, and a chronic utero-placental hypoperfusion, which is caused by a failure of implantation during the first trimester of pregnancy, has been confirmed.

A hypoxic environment surrounds the embryonic implantation and the first steps of the placental development into uterus. Moreover, the maternal-foetal exchanges space (the Inter-Villi Space or IVS) is so maternal-bloodless. At the pregnancy first period are released there uterine secretions and a plasmatic ultra-filtrate. Indeed, the ends of the uterine arteries are plugged by trophoblastic plugs.

It was also accepted that the disappearance of these plugs, a major step in the implementation of the mother-fetal interface, occurred around 10 weeks of amenorrhea (10 SA). However, a recent study questions this dogma since the presence of blood in the intervilleous chamber has just been detected as early as 6 weeks of amenorrhea (6SA). In addition, an increase in blood flow within the IVS is found between 6 and 13 SA. Thus, it would appear that chronic placental hypoperfusion phenomena are more related to a vascular flow defect within the IVS than to the disappearance of endovascular plugs.

These new advances come from a single recent publication which was carried out on a small number of people (maximum 4 women per group).

It is therefore essential to carry out further studies to confirm that the infusion of IVS occurs very early and to evaluate the evolution of infusion kinetics with gestational age.

The detection of blood in the IVS from 6 SA was made possible by the injection of an ultrasound vascular contrast agent. This contrast agent does not have marketing authorization in women and its use is therefore not possible during the course of the progressive desired pregnancies. This study can therefore only be conducted in women who have confirmed a desire for voluntary interruption of pregnancy.

Since 2004, the quantification of the placental and uterine vascularization is possible by Doppler 3D ultrasound angiography but this technique has only been evaluated from 11SA. The advantage of this technique is that it does not require the injection of contrast agent, but the main limitation is that the Doppler signal observed is not necessarily specific to a blood flow. Thus, it would be interesting to evaluate whether 3D Doppler ultrasound angiography would make it possible to quantify the perfusion of the IVS early, compared to contrast ultrasound. If this is the case, the use of contrast media would no longer be necessary to evaluate the evolution of placental flux in future studies.

Recent data challenge ideas that have been accepted for decades. It is crucial to continue early exploration in order to understand the kinetics of maternal blood development in the IVS.

This kinetic would have a major impact on the progression of pregnancy and it analysis may permit a screening test and an early diagnosis for PE- or IUGR-risky pregnancies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study of the Measurement of the Placental Perfusion During the First Trimester of Pregnancy by 3D Doppler Echo-angiography With a Contrast Agent
Actual Study Start Date : October 12, 2016
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: surgical termination of pregnancy
Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients for ultrasound angiography during the termination of pregnancy. 2,4 mL are administrated per patient, divided into two injections of 1,2 mL.
Drug: Contrast agent: SonoVue®.
SonoVue® Injection: will be done through the peripheral venous way already set up by the anesthetist for its injection. None venous dedicated way will be established. The injection will take place when the woman will be under general anesthesia, ventilated and under constant cardio-respiratory monitoring.
Other Name: hexafluoride




Primary Outcome Measures :
  1. The measurement of signal strength [ Time Frame: 1 day ]
    The measurement of signal strength (in arbitrary units) in the Inter-Villi Space in the first trimester (at 8SA, 11SA and 13SA) obtained by contrast ultrasound, in women who have confirmed a voluntary termination of pregnancy.


Secondary Outcome Measures :
  1. Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: signal strength [ Time Frame: 1 day ]
    Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: signal strength

  2. Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: infusion kinetics. [ Time Frame: 1 day ]
    Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: infusion kinetics.

  3. Comparison of quantitative data on uteroplacental vascularization obtained with the 2 techniques. [ Time Frame: 1 day ]
    Comparison of quantitative data on uteroplacental vascularization obtained with the 2 techniques: by 3D Doppler ultrasound angiography without a contrast agent and by ultrasound with a contrast agent: SonoVue®.

  4. Obtaining analyzable placental villi for the study of the development and functions of the human placenta. [ Time Frame: 1 day ]

    Obtaining analyzable placental villi for the study of the development and functions of the human placenta.

    Placental tissue collected will be analyzed to better understand the development and function of the placenta during pregnancy in a subsequent search. The genetic polymorphism research of some placental genes may also be performed.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years and <65 years,
  • Gestational Age: 8 SA ≤ gestational age ≤ 8 SA + 6 days or 11 SA ≤ gestational age ≤ 11 SA + 6 days,
  • BMI ≤40 kg / m²,
  • Having confirmed his request for termination of pregnancy surgically

Exclusion Criteria:

  1. Any medical contraindication for administration of

    SonoVue including:

    • Hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue®,
    • Women with recent acute coronary syndrome or suffering from an unstable ischemic heart disease,
    • women having a right-left shunt, severe pulmonary hypertension (pulmonary artery pressure> 90 mmHg), an uncontrolled systemic hypertension and woman with respiratory distress syndrome
  2. Women with risk for IUGR / PE namely:

    • Previous history of PE or stunting staff
    • Autoimmune disease,
    • Chronic Hypertension
    • Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884297


Locations
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France
Chr Metz Thionville
Metz, France, 57085
CHRU de NANCY
Nancy, France, 54511
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
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Principal Investigator: Marie-Laure ESZTO-CAMBON, MD CHR Metz-Thionville

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02884297    
Other Study ID Numbers: 2016-01-CHRMT
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided