Trials / Recruiting

RecruitingNCT07422181

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 5 (estimated)

Sponsor: Maxima Medical Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

Adequate blood flow to the placenta is critical for normal fetal development and positive pregnancy outcomes. A key component of this process is the maternal uterine spiral arteries, which undergo significant physiological remodeling during pregnancy to meet the growing demands of the fetus. When this remodeling is impaired, it has been linked to complications such as preeclampsia, fetal growth restriction, and placental abruption. Despite its importance, directly and non-invasively assessing the maternal uterine microvasculature-particularly spiral arteries-remains difficult. Conventional Doppler ultrasound only provides indirect insights by estimating vascular resistance at a macroscopic level and cannot visualize spiral arteries or directly evaluate placental perfusion. Contrast-enhanced ultrasound (CEUS) represents a promising alternative, as it improves visualization of small vessels through the use of ultrasound contrast agents (UCAs). Since UCAs are currently not approved for use during pregnancy, this study focuses on assessing the feasibility of CEUS for visualizing persistent spiral arteries in the immediate postpartum period, as an initial step toward investigating the maternal side of the placenta. In addition, Doppler waveform analysis of the uterine arteries will be performed at three time points: before delivery, during labor, and after birth. Combining CEUS with Doppler imaging may provide a more comprehensive understanding of dynamic uteroplacental vascular changes around delivery. The primary objectives are to determine whether maternal uterine spiral arteries remain present after delivery and to evaluate the feasibility of CEUS with UCAs in visualizing and characterizing these arteries within four hours postpartum. Secondary objectives include assessing uterine artery Doppler parameters before, during, and after delivery to describe peripartum hemodynamic changes, and correlating CEUS findings at four hours postpartum with Doppler measurements.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SonoVue (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.

Timeline

Start date: 2025-12-17
Primary completion: 2026-06-01
Completion: 2026-07-01
First posted: 2026-02-19
Last updated: 2026-02-19

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07422181. Inclusion in this directory is not an endorsement.