RecruitingNot ApplicableNCT07422181

PlaCEUS: Feasibility Study of Contrast-enhanced Ultrasound to Visualize Maternal Uterine Spiral Arteries Postpartum.


Sponsor

Maxima Medical Center

Enrollment

5 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

During pregnancy, unique blood vessels form within the uterine wall, known as spiral arteries. These vessels originate from the uterine artery, which is the main artery supplying blood to the uterus. Throughout pregnancy, spiral arteries undergo significant changes to increase blood and oxygen flow to the placenta, ensuring the developing baby receives adequate nutrients. When these arteries fail to remodel properly, complications such as pre-eclampsia or fetal growth restriction can occur. Until now, direct observation and evaluation of spiral arteries during pregnancy has not been feasible. Contrast-enhanced ultrasound may provide a breakthrough in this area. In this study, the investigators aim to use this imaging technique to visualize spiral arteries after the placenta has been delivered. If successful, this could allow to assess their structural quality. Additionally, the investigators will employ ultrasound to monitor physiological changes in the uterine artery during late pregnancy (after 37 weeks), during labour, and postpartum. By conducting these measurements, the investigators hope to develop methods for detecting spiral artery abnormalities earlier in pregnancy. Early identification could enable timely interventions and help prevent severe complications.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Pregnant patient at a minimum age of 18 years
  • Singleton pregnancy at term (≥37 weeks gestation)
  • Planning to deliver at the Máxima Medical Centre
  • Able to provide informed consent
  • Intravenous access present at the time of delivery

Exclusion Criteria8

  • Multiple gestation pregnancy
  • Contra-indications to CEUS, e.g. known allergy for constituents of SonoVue™
  • Planning on breastfeeding
  • Medical emergency during or after delivery, which makes CEUS impossible or undesirable
  • No intravenous access present at the time of delivery
  • Body Mass Index >40 kg/m2.
  • Pre-eclampsia requiring medication
  • Foetal growth restriction < p3

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Interventions

DIAGNOSTIC_TESTSonoVue (sulphur hexafluoride microbubbles)

SonoVue will be used in this study as ultrasound contrast agents for contrast enhanced ultrasound to assess the feasibility in visualizing and charactering the persistence of maternal uterine spiral arteries within 4 hours postpartum.


Locations(1)

Máxima Medical center

Veldhoven, Netherlands

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NCT07422181


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