ClinicalTrials.gg
Not yet recruitingNCT07832019PCIAUpdated Sep 21, 2026

Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity

An observational study in Placenta Accreta Spectrum, Placenta Previa and Placenta Accreta, sponsored by Necmettin Erbakan University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Necmettin Erbakan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Placenta Accreta Spectrum
  • Placenta Previa
  • Placenta Accreta

Keywords

  • placenta-cervical interface angle
  • PAS severity
  • perinatal outcome
03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 100 is above the median of 87 across 78 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age greater than 20 weeks
  • Placenta previa or low-lying placenta
  • Suspected placenta accreta spectrum
  • History of cesarean delivery

Exclusion criteria

Exclusion Criteria:

  • Major fetal anomaly
  • Multiple pregnancy
  • Uterine malformation
  • Inadequate image quality
  • Active vaginal bleeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Pregnant women at risk of PAS

Interventions

  • ProcedurePregnant women at risk of PAS

    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.

06

What researchers measure

Primary outcomes

  1. Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum

    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.

    Time frame: From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery

Secondary outcomes

  1. Estimated intraoperative blood loss

    Estimated intraoperative blood loss, measured in milliliters (mL).

    Time frame: At delivery / cesarean surgery

  2. Adverse neonatal outcome

    Proportion of neonates with an adverse outcome, defined as neonatal intensive care unit (NICU) admission, measured as percentage of neonates.

    Time frame: At delivery and the immediate neonatal period

  3. Inter-observer reproducibility of PCIA measurement

    Intraclass correlation coefficient (ICC) of the PCIA measured independently by two operators in approximately 20% of participants.

    Time frame: At the time of antenatal ultrasound assessment

  4. Red blood cell transfusion

    Number of units of red blood cells transfused, measured in units

    Time frame: At delivery and during the perioperative period

  5. Operative time

    Total duration of the surgical procedure, measured in minutes

    Time frame: At delivery / cesarean surgery

  6. Hysterectomy

    Proportion of participants requiring hysterectomy, measured as percentage of participants.

    Time frame: At delivery / cesarean surgery

  7. Intensive care unit admission

    Proportion of participants requiring intensive care unit admission, measured as percentage of participants

    Time frame: During the postoperative hospital stay

07

Study locations

1 site
  • Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic
    Konya, Konya 42090, Turkey (Türkiye)
08

References and documents

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. PubMed 34725869 ↗
  • 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. PubMed 39096965 ↗
  • 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. PubMed 41011001 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared outside the study team.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.

Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 21, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Apr 15, 2027
CompletionEst.
May 15, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832019
Responsible party
Hatice Şule Mazloomyar (Specialist, Obstetrics and Gynecology / Perinatology, Necmettin Erbakan University) — Principal investigator
First posted
Sep 21, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
May 15, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Hatice Sule Mazloomyar, MD
Contact
haticesulemazloomyar@erbakan.edu.tr
05061194179
Ali ACAR, Prof.Dr
principal investigator · Necmettin Erbakan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion