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Spiral ArteriesPlaCEUSNCT07422181

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

A study testing SonoVue (sulphur hexafluoride microbubbles) in people with Spiral Arteries and Uterine Artery Hemodynamics, run by Maxima Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
SonoVue (sulphur hexafluoride microbubbles)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteNetherlands
Study dates
17 Dec 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eveline Dekker, Drs contact

+3140 888 83 80

e.dekker@mmc.nl

Loes Monen, Dr. contact

+3140 888 83 80

Netherlands1 site, 1 recruiting
  • Máxima Medical center

    Veldhoven, 5504DB

    Recruiting

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
SonoVue (sulphur hexafluoride microbubbles)
Keywords
Spiral arteries, Uterine artery hemodynamics, contrast enchanced ultrasound
Medical subject headings
Systolic Murmurs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonoVue (sulphur hexafluoride microbubbles)Diagnostic test

    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.

Study groups in NCT07422181
Study groupRoleWhat they receive
CEUSExperimentalAll participants included in the study will receive contrast enhanced ultrasound imaging postpartum. During pregnancy, during labour and postpartum Doppler parameters of the uterine arterie will be performed.
Receives: Diagnostic Test: SonoVue (sulphur hexafluoride microbubbles)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with persisting spiral arteries detected by contrast enhanced ultrasound within 4 hours postpartum.

    Presence of persisting spiral arteries will be assessed using contrast enhanced ultrasound (CEUS) with Sonovue within 4 hours postpartum. The transition of spiral arteries into the intervillous space will be identified at the interface between the decidua and the basal plate of the placenta. Depending on placental location, a sagittal or coronal plane will be selected for optimal visualization. The probe will be positioned perpendicular (90°) to the uteroplacental interface, and color Doppler will be activated to confirm unidirectional flow at the spiral artery opening.

    Persistence of spiral arteries will be determined as a dichotomous outcome. Visbile or not visible. The number of patients will be calculated in whom the result was: visible.

    Measured: Within 4 hours postpartum

  2. Feasibility of Contrast Enhanced Ultrasound (CEUS) with Sonovue for visualizing spiral arteries within 4 hours postpartum. Dichotomous outcome; visible or invisible spiral arteries.

    Feasibility will be assessed by determining whether CEUS with Sonovue successfully visualizes and characterizes maternal uterine spiral arteries within 4 hours postpartum. A scan will be considered feasible if the transition of spiral arteries into the intervillous space can be identified at the uteroplacental interface using the predefined imaging protocol (correct probe orientation, sagittal/coronal plane selection, and confirmation of unidirectional flow with color Doppler). The outcome is dichotomous. The spiral arteries are visible or not visible.

    Measured: Within 4 hours postpartum

Secondary outcomes (4)
  1. Change in uterine artery Resistance Index (RI) across peripartum period

    Uterine artery resistance index (RI) will be measured using Doppler ultrasound before delivery (after 37 weeks) Uterine artery resistance index (RI) will be measured using Doppler ultrasound during delivery (active labor or same day prior to cesarean) Uterine artery resistance index (RI) will be measured using Doppler ultrasound within 4 hours postpartum.

    Measured: Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.

  2. Change in uterine artery Pulsatility Index (PI) across peripartum period

    Uterine artery pulsatility index (PI) will be measured using Doppler ultrasound before delivery (after 37 weeks),

    Uterine artery pulsatility index (PI) will be measured using Doppler ultrasound during delivery (active labor or same day prior to cesarean) Uterine artery pulsatility index (PI) will be measured using Doppler ultrasound within 4 hours postpartum.

    The change in PI will be assesed as delta PI, both absolute as in percentage change of PI.

    Measured: Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.

  3. Change in uterine artery Systolic/Diastolic Ratio across peripartum period

    Uterine artery systolic/diastolic ratio will be measured using Doppler ultrasound at three time points: before delivery (after 37 weeks), during delivery (active labor or same day prior to cesarean), and within 4 hours postpartum.

    Measured: Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.

  4. Correlating CEUS findings with uterine artery Doppler parameters within 4 hours postpartum

    Correlation will be assessed between CEUS findings (presence of persisting spiral arteries detected using contrast enhanced ultrasound with Sonovue) and uterine artery Doppler parameters (Resistance Index [RI], Pulsatility Index [PI], and Systolic/Diastolic ratio). CEUS will follow the standardized imaging protocol for spiral artery visualization, and Doppler measurements will be obtained using standard obstetric ultrasound techniques.

    Measured: Within 4 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start17 Dec 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07422181
Sponsor's protocol ID
NL010727
Acronym
PlaCEUS
Status last verified
Feb 2026
First submitted
17 Dec 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All participant will sign informed consent stating that all data will be used anonymously.

Publications

  • Collins SL, Birks JS, Stevenson GN, Papageorghiou AT, Noble JA, Impey L. Measurement of spiral artery jets: general principles and differences observed in small-for-gestational-age pregnancies. Ultrasound Obstet Gynecol. 2012 Aug;40(2):171-8. doi: 10.1002/uog.10149.

    PubMed 22102536
  • Roberts VHJ, Morgan TK, Bednarek P, Morita M, Burton GJ, Lo JO, Frias AE. Early first trimester uteroplacental flow and the progressive disintegration of spiral artery plugs: new insights from contrast-enhanced ultrasound and tissue histopathology. Hum Reprod. 2017 Dec 1;32(12):2382-2393. doi: 10.1093/humrep/dex301.

    PubMed 29136193
  • Li Q, Yang K, Ji Y, Liu H, Fei X, Zhang Y, Li J, Luo Y. Safety Analysis of Adverse Events of Ultrasound Contrast Agent Lumason/SonoVue in 49,100 Patients. Ultrasound Med Biol. 2023 Feb;49(2):454-459. doi: 10.1016/j.ultrasmedbio.2022.09.014. Epub 2022 Nov 7.

    PubMed 36357252
  • Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.

    PubMed 18270887
  • Dassen S, Monen L, Oei G, Mischi M, van Laar J. Safety of contrast-enhanced ultrasound using microbubbles in human pregnancy: A scoping review. Ultraschall Med. 2025 Jun;46(3):259-269. doi: 10.1055/a-2351-0747. Epub 2024 Jun 24.

    PubMed 38914129
  • European Medicines Agency (EMA). SonoVue, INN-sulphur hexafluoride: EPAR - Product Information. EMA. Last updated: 05 June 2023. Available from: https://www.ema.europa.eu/en/documents/product-information/sonovue-epar-product-information_en.pdf

Questions about this trial

What is this clinical trial studying?

A study testing SonoVue (sulphur hexafluoride microbubbles) in people with Spiral Arteries and Uterine Artery Hemodynamics, run by Maxima Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eveline Dekker, Drs (+3140 888 83 80, e.dekker@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with persisting spiral arteries detected by contrast enhanced ultrasound within 4 hours postpartum. (time frame: Within 4 hours postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07422181, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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