Skip to main content
OpenTrials
Completed

NCT Number: NCT04314791

Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine, Mansoura University

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound evaluation, with grayscale and color Doppler imaging

Device

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.

Primary outcomes

  1. Diagnostic accuracy of the PAI

    Time frame: through study completion, an average of 1 year

    The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.

Sponsors and collaborators

Lead sponsor

Hatem AbuHashim

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.