Actively Recruiting

Phase 3
Age: 18Years - 64Years
FEMALE
ID06497959

Contribution of Contrast-Enhanced Ultrasound in Studying Fetal-Placental Circulation During Medical Termination of Pregnancy

Led by Central Hospital, Nancy, France · Updated on 2026-04-07

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Preeclampsia and intrauterine growth restriction (IUGR) are major pregnancy complications related to problems in the placenta's blood vessels, but their causes are not fully understood. Currently, no treatments target these conditions directly, and delivering the baby early is the only option to prevent serious complications like fetal death. Researchers aim to better understand how blood flows through the placenta during healthy and complicated pregnancies using new imaging techniques. This study compares placental blood flow in women undergoing medical termination of pregnancy between 16 and 38 weeks of gestation. It involves 30 women divided into two groups: those with severe fetal growth restriction and those without. The study uses contrast-enhanced ultrasound with SonoVue, a contrast agent injected into the mother, to separately examine blood flow on the maternal and fetal sides of the placenta. This method is being tested for safety and usefulness in providing detailed placental blood flow information. Participants will undergo placental ultrasound scans to measure blood flow signals and vascular parameters during the study day. Histological analysis of the placenta will also be performed after termination to compare with imaging results. The main measure is the strength of the ultrasound signal, with additional assessments of blood flow in specific placental areas. The study will last about 48 months and includes follow-up to analyze vascularization over an average of 24 months.

CONDITIONS

Brief Title

Study of Placental Vascularization Using Contrast Ultrasound

Who Can Participate

Age: 18Years - 64Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult woman aged 18 years or older
  • Gestational age between 16 weeks 0 days and 38 weeks 6 days
  • Singleton pregnancy
  • Medical termination of pregnancy request accepted in writing by the prenatal diagnostic center
  • Affiliated with social security or equivalent system
  • Provided informed consent after full information
  • Severe growth restriction group: fetal weight estimated below 3rd percentile by ultrasound within 15 days before termination (for that group only)
Not Eligible

You will not qualify if you...

  • Unable to speak French
  • Medical conditions contraindicating SonoVue, including hypersensitivity to sulfur hexafluoride or polyethylene glycol
  • Recent acute coronary syndrome or unstable ischemic heart disease
  • Right-to-left heart shunt, severe pulmonary arterial hypertension (pressure >90 mmHg), uncontrolled systemic hypertension, or respiratory distress
  • Breastfeeding mothers
  • Minors or adults under legal protection unable to consent
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care as defined by French public health code

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo placental contrast ultrasound using SonoVue by maternal intravenous injection to assess fetal-placental circulation.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 24 months

Participants' placenta vascularization is compared using histological analysis over the study period.

Follow-up visits may occur as needed during the study period

Trial Site Locations

Total: 1 location

1

CHRU de NANCY

Nancy, France, 54000

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Research Team

M

Matthieu DAP, Doctor

J

Juliette LEFEBVRE, Junior doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Contributions of contrast-enhanced ultrasound (CEUS) to a fetal-placental circulation study (EVUPACUS): a protocol for a prospective comparative study in a population of women undergoing termination of pregnancy.

Juliette Lefebvre, Aboubaker Cherifi, Gabriela Hossu...

https://pubmed.ncbi.nlm.nih.gov/40784773