Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

Sponsor
Hatem AbuHashim (Other)
Overall Status
Completed
CT.gov ID
NCT04314791
Collaborator
(none)
100
1
18
5.6

Study Details

Study Description

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.

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound evaluation, with grayscale and color Doppler imaging

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
US scan with calculation of the PAI

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.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of the PAI [through study completion, an average of 1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Mansoura University Mansoura Egypt

Sponsors and Collaborators

  • Hatem AbuHashim

Investigators

  • Study Chair: Hatem Abu Hashim, Faculty of Medicine, Mansoura University
  • Principal Investigator: Eman Shalaby, Mansoura University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hatem AbuHashim, Professor, Mansoura University
ClinicalTrials.gov Identifier:
NCT04314791
Other Study ID Numbers:
  • MS.17.04.143
First Posted:
Mar 19, 2020
Last Update Posted:
Mar 19, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2020