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

NCT07422181 | Recruiting DMC

• 1 other identifier: NL010727
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spiral Arteries; Uterine Artery Hemodynamics; Contrast Enhanced Ultrasound; Doppler Parameters; Resistance Index; Pulsatility Index; Systolic/Diastolic Ratio

Keywords

Spiral arteries; Uterine artery hemodynamics; contrast enchanced ultrasound

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 4 hours postpartum

• 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.

  Within 4 hours postpartum

Secondary Outcomes (4)

• Change in uterine artery Resistance Index (RI) across peripartum period

  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.

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

  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.

• Change in uterine artery Systolic/Diastolic Ratio across peripartum period

  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.

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

  Within 4 hours postpartum

Study Arms (1)

CEUS

EXPERIMENTAL

All 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.

Diagnostic Test: SonoVue (sulphur hexafluoride microbubbles)

Interventions

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.

CEUS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants with the potential to become pregnant.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Máxima Medical center

Veldhoven, 5504DB, Netherlands

RECRUITING

Related Publications (6)

• 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;40(2):171-178. doi:10.1002/uog.10149.

  BACKGROUND

• Roberts VHJ, Morgan TK, Bednarek P, et al. 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;32(12):2382-2393. doi:10.1093/humrep/dex301

  BACKGROUND

• Li QY, Li Y, Li X, Liu Y, Zhang Y, Zhang Y, et al. Safety analysis of adverse events of ultrasound contrast agent Lumason/SonoVue in 49,100 patients. Front Cardiovasc Med. 2022;9:1003452. doi:10.3389/fcvm.2022.1003452.

  BACKGROUND

• Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, et al. Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) - Update 2008. Ultraschall Med. 2008;29(1):28-44. doi: 10.1055/s-2007-963785

  BACKGROUND

• 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.

  PMID: 38914129 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Systolic Murmurs

Condition Hierarchy (Ancestors)

Heart Murmurs; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eveline Dekker, Drs

CONTACT

+3140 888 83 80; e.dekker@mmc.nl

Loes Monen, Dr.

CONTACT

+3140 888 83 80

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 19, 2026
• Study Start: December 17, 2025
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)