NCT02884297

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®

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3 pregnancy

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 6, 2019

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

July 14, 2016

Last Update Submit

December 5, 2019

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • The measurement of signal strength

    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.

    1 day

Secondary Outcomes (4)

  • Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: signal strength

    1 day

  • Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: infusion kinetics.

    1 day

  • Comparison of quantitative data on uteroplacental vascularization obtained with the 2 techniques.

    1 day

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

    1 day

Study Arms (1)

surgical termination of pregnancy

EXPERIMENTAL

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®.

Interventions

Contrast agent: SonoVue®.DRUG

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.

Also known as: hexafluoride
surgical termination of pregnancy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Women with risk for IUGR / PE namely:
  • Previous history of PE or stunting staff
  • Autoimmune disease,
  • Chronic Hypertension
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chr Metz Thionville

Metz, 57085, France

Location

CHRU de NANCY

Nancy, 54511, France

Location

Related Publications (1)

  • Bertholdt C, Eszto ML, Tournier M, Hossu G, Mellouki N, Cherifi A, Morel O. Assessment of uteroplacental vascularisation in early first-trimester pregnancy with contrast-enhanced ultrasound and 3D power Doppler angiography: protocol for a prospective, cross-sectional, multicentre and non-randomised open study ("HOPE Study"). BMJ Open. 2019 Sep 11;9(9):e030353. doi: 10.1136/bmjopen-2019-030353.

    PMID: 31511289DERIVED

MeSH Terms

Interventions

contrast agent BR1

Study Officials

  • Marie-Laure ESZTO-CAMBON, MD

    CHR Metz-Thionville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

August 31, 2016

Study Start

October 12, 2016

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

December 6, 2019

Record last verified: 2018-04

Locations

FR(2)