Clinical trial NCT04314791: Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
Official title: Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta Spectrum
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant females during the third trimester of pregnancy, with a single fetus in the current pregnancy, a previous delivery by at least 1 cesarean section and having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

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.


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.

Primary outcomes:
measure: Diagnostic accuracy of the PAI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Hatem Abu Hashim
role: STUDY_CHAIR
affiliation: Mansoura University Hospital
name: Eman Shalaby
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.