Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity (PCIA)
Placenta-Cervical Interface Angle: A Novel Sonographic Marker for Predicting Placenta Accreta Spectrum Severity and Perinatal Outcomes
Placenta accreta spectrum (PAS) is associated with substantial maternal and neonatal morbidity, and accurate antenatal prediction of its severity remains challenging. Although several sonographic markers exist, most are subjective and operator-dependent, and few predict surgical complexity or adverse perinatal outcomes. This prospective observational cohort study evaluates the Placenta-Cervical Interface Angle (PCIA), a novel geometric transvaginal ultrasound marker, defined as the angle between the longitudinal axis of the cervical canal and the tangent line drawn to the lower placental edge. The study assesses the predictive performance of the PCIA for severe PAS and its association with intraoperative morbidity and adverse perinatal outcomes.
Study Overview
Status
Intervention / Treatment
Detailed Description
Pregnant women with placenta previa or an anteriorly located low-lying placenta followed at the Perinatology Clinic, Necmettin Erbakan University Faculty of Medicine, will be enrolled prospectively. Using transvaginal ultrasonography in the sagittal plane, the Placenta-Cervical Interface Angle (PCIA) will be measured as the angle formed between the longitudinal axis along the cervical canal and the tangent line to the lower placental edge. All measurements will be performed with an empty bladder in the lithotomy position using a Voluson 8 ultrasound system within the same gestational-age window. Classic sonographic PAS markers will also be assessed, including placental lacunae, bridging vessels, loss of the clear zone, myometrial thickness, bladder-wall invasion, and cervical length. Demographic and clinical variables (age, BMI, gravidity, parity, smoking, IVF versus spontaneous conception, prior cesarean and other uterine surgery) will be recorded. Surgical and perinatal outcomes, including operative time, estimated blood loss, red-blood-cell transfusion, intensive-care requirement, hysterectomy, and neonatal outcomes, will be recorded. To assess reproducibility, a second operator will repeat the measurement in approximately 20% of participants and the intraclass correlation coefficient (ICC) will be calculated. Data will be analyzed with SPSS. The predictive performance of the PCIA for severe PAS and adverse perinatal outcomes will be evaluated by ROC analysis, with the optimal cut-off determined by the Youden index; sensitivity, specificity, and positive and negative predictive values will be calculated. Multivariable logistic regression will be used to identify independent predictors. A p-value below 0.05 will be considered statistically significant.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hatice Sule Mazloomyar, MD
- Phone Number: 05061194179
- Email: haticesulemazloomyar@erbakan.edu.tr
Study Locations
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Konya
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Konya, Konya, Turkey (Türkiye), 42090
- Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic
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Contact:
- Hatice Şule Mazloomyar
- Phone Number: 05061194179
- Email: sule.icolak@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Pregnant women at or beyond 20 weeks of gestation with placenta previa or an anterior low-lying placenta and suspected placenta accreta spectrum, followed at a single tertiary perinatology clinic.
Description
Inclusion Criteria:
- Gestational age greater than 20 weeks
- Placenta previa or low-lying placenta
- Suspected placenta accreta spectrum
- History of cesarean delivery
Exclusion Criteria:
- Major fetal anomaly
- Multiple pregnancy
- Uterine malformation
- Inadequate image quality
- Active vaginal bleeding
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pregnant women at risk of PAS
Pregnant women at or beyond 20 weeks of gestation with placenta previa or an anterior low-lying placenta and suspected placenta accreta spectrum, undergoing transvaginal measurement of the Placenta-Cervical Interface Angle and followed to delivery. |
Transvaginal ultrasonography performed in the sagittal plane to measure the Placenta-Cervical Interface Angle (PCIA), defined as the angle between the longitudinal axis of the cervical canal and the tangent to the lower placental edge, together with assessment of classic sonographic PAS markers. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum
Time Frame: From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery
|
Diagnostic accuracy of the sonographically measured PCIA for predicting surgically or histologically confirmed severe PAS, expressed as area under the ROC curve (AUC), sensitivity, specificity, and positive and negative predictive values. The optimal cut-off is determined by the Youden index. |
From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated intraoperative blood loss
Time Frame: At delivery / cesarean surgery
|
Estimated intraoperative blood loss, measured in milliliters (mL). |
At delivery / cesarean surgery
|
|
Adverse neonatal outcome
Time Frame: At delivery and the immediate neonatal period
|
Proportion of neonates with an adverse outcome, defined as neonatal intensive care unit (NICU) admission, measured as percentage of neonates. |
At delivery and the immediate neonatal period
|
|
Inter-observer reproducibility of PCIA measurement
Time Frame: At the time of antenatal ultrasound assessment
|
Intraclass correlation coefficient (ICC) of the PCIA measured independently by two operators in approximately 20% of participants. |
At the time of antenatal ultrasound assessment
|
|
Red blood cell transfusion
Time Frame: At delivery and during the perioperative period
|
Number of units of red blood cells transfused, measured in units |
At delivery and during the perioperative period
|
|
Operative time
Time Frame: At delivery / cesarean surgery
|
Total duration of the surgical procedure, measured in minutes |
At delivery / cesarean surgery
|
|
Hysterectomy
Time Frame: At delivery / cesarean surgery
|
Proportion of participants requiring hysterectomy, measured as percentage of participants. |
At delivery / cesarean surgery
|
|
Intensive care unit admission
Time Frame: During the postoperative hospital stay
|
Proportion of participants requiring intensive care unit admission, measured as percentage of participants |
During the postoperative hospital stay
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali ACAR, Prof.Dr, Necmettin Erbakan University
Publications and helpful links
General Publications
- Skupski DW, Duzyj CM, Scholl J, Perez-Delboy A, Ruhstaller K, Plante LA, Hart LA, Palomares KTS, Ajemian B, Rosen T, Kinzler WL, Ananth C; Perinatal Research Consortium. Evaluation of classic and novel ultrasound signs of placenta accreta spectrum. Ultrasound Obstet Gynecol. 2022 Apr;59(4):465-473. doi: 10.1002/uog.24804.
- Agarwal N, Hernandez-Andrade E, Sibai BM, Amro FH, Coselli JO, Bartal MF, Lai D, Torres EES, Backley S, Johnson A, Espinoza J, Bergh EP, Zhu S, Salazar A, Blackwell SC, Papanna R. Quantifying placenta accreta spectrum severity and its associated blood loss: a novel transvaginal ultrasound scoring system. Am J Obstet Gynecol MFM. 2024 Oct;6(10):101451. doi: 10.1016/j.ajogmf.2024.101451. Epub 2024 Aug 5.
- Varthaliti A, Psarris A, Koutroumanis P, Gkiaourakis G, Daskalaki MA, Antsaklis P, Daskalakis G, Theodora M. Prognostic Significance of Serial Ultrasonography in Placenta Accreta Spectrum and Its Impact on Perinatal Outcomes. Medicina (Kaunas). 2025 Sep 5;61(9):1612. doi: 10.3390/medicina61091612.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-2026-6714
- Ethics approval (Other Identifier: Necmettin Erbakan University Non-Interventional Clinical Research Ethics Committee (Application ID 31937))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared outside the study team.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
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