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Clinical Trials/NCT04229953
NCT04229953
Unknown
Not Applicable

Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum: A Prospective Study

Hatem AbuHashim0 sites113 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Placenta Accreta Spectrum
Sponsor
Hatem AbuHashim
Enrollment
113
Primary Endpoint
Diagnostic accuracy of 3D/4D VRU software
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
March 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hatem AbuHashim
Responsible Party
Sponsor Investigator
Principal Investigator

Hatem AbuHashim

Professor

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Pregnant women in their third trimester
  • with a single fetus in the current pregnancy
  • a previous delivery by at least 1 cesarean section
  • having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment

Exclusion Criteria

  • cases with twin or multiple pregnancies,
  • cases with a non-previa placenta or posterior low lying or previa placenta,
  • cases without previous deliveries by cesarean section
  • cases before the third trimester of pregnancy.

Outcomes

Primary Outcomes

Diagnostic accuracy of 3D/4D VRU software

Time Frame: Intra-operative (i.e. during surgery).

The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.

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