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Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum

NCT04229953 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2020-01-18

No results posted yet for this study

Summary

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.

Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler. Magnetic resonance imaging (MRI) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available.

Recently, a new imaging technique utilizing three-dimensional (3D)/four-dimensional (4D) volume rendering ultrasound (VRU) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. By using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of PAS which was subsequently confirmed during surgery. Accordingly, The aim of this study is to examine the diagnostic performance of 3D/four-dimensional (4D) volume rendering ultrasound (VRU) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.

Conditions

  • Placenta Accreta Spectrum

Interventions

DEVICE

US scan with 3D/4D VRU software

Every patient will be evaluated by grayscale 2D-ultrasound and color Doppler. Then, a Samsung WS 80A Elite US scanner with 3D/4D VRU software will be used to assess the placental invasion by applying the two modes ("crystal vue" and "realistic vue"). The image analysis will be performed after obtaining the volume dataset. Data will be compared with the intraoperative findings and histopathological confirmation if hysterectomy will be done.

Sponsors & Collaborators

  • Hatem AbuHashim

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim · Faculty of Medicine, Mansoura University

  • Asmaa Mahran · Mahala General Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-02-01
Completion
2021-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229953 on ClinicalTrials.gov