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

Placenta Accreta Spectrum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229953
• Other study ID #: MS.19.05.656
• Status: Not yet recruiting
• Start date: February 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2020
• Source: Mansoura University
• Contact: Hatem Abu Hashim, MD.FRCOG.PhD
• Phone: +20502300002
• Email: hatem_ah[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 113
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

References & Publications (1)

Aryananda RA, Akbar A, Wardhana MP, Gumilar KE, Wicaksono B, Ernawati E, Sulistyono A, Aditiawarman A, Joewono HT, Dachlan EG, Parange A, Dekker GA. New three-dimensional/four-dimensional volume rendering imaging software for detecting the abnormally inva — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of 3D/4D VRU software	The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.	Intra-operative (i.e. during surgery).