Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

Placenta Accreta Spectrum Clinical Trial

Official title:

Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314791
• Other study ID #: MS.17.04.143
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: Mansoura University
• Contact: n/a
• 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.

The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict PAS based on US parameters in a high-risk population by retrospective data analysis. The probability of histological invasion was found to increase with increasing the PAI score. This study aimed to prospectively evaluate the diagnostic performance of the PAI in the prediction of PAS in relation to histopathological findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 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:
• Ultrasound evaluation, with grayscale and color Doppler imaging
In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Rac MW, Dashe JS, Wells CE, Moschos E, McIntire DD, Twickler DM. Ultrasound predictors of placental invasion: the Placenta Accreta Index. Am J Obstet Gynecol. 2015 Mar;212(3):343.e1-7. doi: 10.1016/j.ajog.2014.10.022. Epub 2014 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the PAI	The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.	through study completion, an average of 1 year