Placenta Accreta SpectrumPCIANCT07832019
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
An observational study of Placenta Accreta Spectrum and Placenta Previa, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta Spectrum, Placenta Previa, Placenta Accreta
- What is being tested?
- Pregnant women at risk of PAS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Gestational age greater than 20 weeks
- Placenta previa or low-lying placenta
- Suspected placenta accreta spectrum
- History of cesarean delivery
Who cannot join
- Major fetal anomaly
- Multiple pregnancy
- Uterine malformation
- Inadequate image quality
- Active vaginal bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic
Konya, Konya, 42090
Hatice Şule Mazloomyar, 05061194179, sule.icolak@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Placenta Accreta Spectrum, Placenta Previa, Placenta Accreta
- Being tested
- Pregnant women at risk of PAS
- Keywords
- placenta-cervical interface angle, PAS severity, perinatal outcome
- Medical subject headings
- Placenta Accreta, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women at risk of PASProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pregnant women at risk of PAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery
Secondary outcomes (7)
Estimated intraoperative blood loss
Estimated intraoperative blood loss, measured in milliliters (mL).
Measured: At delivery / cesarean surgery
Adverse neonatal outcome
Proportion of neonates with an adverse outcome, defined as neonatal intensive care unit (NICU) admission, measured as percentage of neonates.
Measured: At delivery and the immediate neonatal period
Inter-observer reproducibility of PCIA measurement
Intraclass correlation coefficient (ICC) of the PCIA measured independently by two operators in approximately 20% of participants.
Measured: At the time of antenatal ultrasound assessment
Red blood cell transfusion
Number of units of red blood cells transfused, measured in units
Measured: At delivery and during the perioperative period
Operative time
Total duration of the surgical procedure, measured in minutes
Measured: At delivery / cesarean surgery
Hysterectomy
Proportion of participants requiring hysterectomy, measured as percentage of participants.
Measured: At delivery / cesarean surgery
Intensive care unit admission
Proportion of participants requiring intensive care unit admission, measured as percentage of participants
Measured: During the postoperative hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Şule Mazloomyar, Necmettin Erbakan University
- Investigators
- Ali ACAR, Prof.Dr, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832019
- Sponsor's protocol ID
- NEU-2026-6714
- Other IDs
- Ethics approval
- Acronym
- PCIA
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team.
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 34725869Agarwal 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 39096965Varthaliti 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placenta-Cervical Interface Angle: A Novel Sonographic Marker for Predicting Placenta Accreta Spectrum Severity and Perinatal Outcomes
- ClinicalTrials.gov ID
- NCT07832019
- Acronym / sponsor ID
- PCIA / NEU-2026-6714
- Conditions
- Placenta Accreta Spectrum, Placenta Previa, Placenta Accreta
- Keywords
- placenta-cervical interface angle, PAS severity, perinatal outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at risk of PAS | – | Procedure: Pregnant women at risk of PASPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Gestational age greater than 20 weeks
- Placenta previa or low-lying placenta
- Suspected placenta accreta spectrum
- History of cesarean delivery
Key exclusion criteria (5 listed)
- Major fetal anomaly
- Multiple pregnancy
- Uterine malformation
- Inadequate image quality
- Active vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant women at risk of PASTransvaginal 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. | Procedure or surgery | Pregnant women at risk of PAS |
Primary outcome
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.
7 secondary outcomes
Estimated intraoperative blood loss
Time frame: At delivery / cesarean surgery
Adverse neonatal outcome
Time frame: At delivery and the immediate neonatal period
Inter-observer reproducibility of PCIA measurement
Time frame: At the time of antenatal ultrasound assessment
Red blood cell transfusion
Time frame: At delivery and during the perioperative period
Operative time
Time frame: At delivery / cesarean surgery
Hysterectomy
Time frame: At delivery / cesarean surgery
Intensive care unit admission
Time frame: During the postoperative hospital stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 34725869Skupski 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.
- Background: PubMed 39096965Agarwal 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.
- Background: PubMed 41011001Varthaliti 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali ACAR, Prof.Dr principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta Spectrum and Placenta Previa, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Sule Mazloomyar, MD (05061194179, haticesulemazloomyar@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832019, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.