Placenta Accreta SpectrumNCT07826247
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
An observational study of Placenta Accreta Spectrum and Placenta Previa, run by Assiut University.
Trial summary
Placenta accreta spectrum (PAS) is a serious pregnancy complication where the placenta attaches too deeply into the wall of the uterus. This condition can lead to severe complications during delivery, including heavy bleeding, the need for blood transfusions, intensive care unit (ICU) admission, or the surgical… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum, Placenta Previa
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 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 to 40 years
- Women only
- Adult
Study population: The study population consists of pregnant women aged 18 to 40 years presenting to the Women's Health Hospital at Assiut University. Eligible participants must have a singleton pregnancy at a gestational age greater than 28 weeks, a diagnosis of placenta previa confirmed by ultrasound, a history of previous cesarean delivery, and be hemodynamically stable upon admission. Patients will be excluded if they present with intrauterine fetal demise (IUFD), intrauterine growth restriction (IUGR), premature rupture of membranes (PROM), chorioamnionitis, known blood diseases or bleeding tendencies, hypertension, or diabetes mellitus.
Who may be able to join
- Age: 18-40 years
- Placenta previa diagnosed by ultrasound
- Singleton pregnancy
- Gestational age >28 weeks
- Previous cesarean delivery
- Hemodynamically stable on admission
Who cannot join
- Intrauterine fetal demise (IUFD)
- Intrauterine growth restriction (IUGR)
- Premature rupture of membranes (PROM)
- Chorioamnionitis
- Patients with known blood disease or bleeding tendency
- Hypertension (HTN)
- Diabetes mellitus (DM)
About this study
Official title: Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Patients With Placenta Previa
Placenta accreta spectrum (PAS) is a serious pregnancy complication where the placenta attaches too deeply into the wall of the uterus. This condition can lead to severe complications during delivery, including heavy bleeding, the need for blood transfusions, intensive care unit (ICU) admission, or the surgical removal of the uterus (hysterectomy).
Currently, doctors primarily use ultrasound to detect PAS before birth, but the accuracy of ultrasound can vary depending on the equipment and the doctor's experience. The main goal of this study is to determine if routine, simple blood tests can serve as an additional tool to help doctors predict which mothers are at the highest risk of developing PAS.
Read more
The study will involve pregnant women who have placenta previa (a low-lying placenta) and a history of a previous cesarean delivery. Researchers will collect a standard blood sample when the mother is admitted to the hospital to look at specific markers, including a complete blood count (CBC) and blood clotting (coagulation) factors.
By comparing these admission blood test results with the actual diagnosis of PAS confirmed during delivery, researchers hope to identify a reliable way to predict this condition. Improving the early detection of PAS could help medical teams better prepare for high-risk deliveries, optimize surgical planning, and ultimately improve health outcomes for mothers.
- Conditions
- Placenta Accreta Spectrum, Placenta Previa
- Keywords
- Hematological markers, Coagulation markers, Complete blood count (CBC), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), D-dimer, Previous cesarean delivery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Placenta Previa and Previous Cesarean Delivery | This cohort consists of pregnant women aged 18 to 40 years with a singleton pregnancy at >28 weeks gestational age. Participants must be diagnosed with placenta previa via ultrasound, have a history of previous cesarean delivery, and be hemodynamically stable on admission. Participants will undergo an antenatal ultrasound to assess for signs of placenta accreta spectrum (PAS). Venous blood samples will be collected upon admission to evaluate complete blood count (CBC) parameters (including calculation of inflammatory indices like NLR, PLR, SII, and SIRI) and a coagulation profile (PT, PC, INR, aPTT, and D-dimer). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Evaluation of the predictive value of the maternal Systemic Immune-Inflammation Index (SII) for diagnosing placenta accreta spectrum (PAS). The SII is calculated from the complete blood count (neutrophils × platelets / lymphocytes) collected on hospital admission. Diagnostic accuracy will be quantified using the Area Under the Receiver Operating Characteristic (ROC) curve to determine the optimal cut-off point, sensitivity, and specificity. The reference standard diagnosis of PAS is confirmed via intraoperative assessment at the time of delivery.
Measured: Within 12 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Khalifa Abdelnour Dous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826247
- Sponsor's protocol ID
- Markers for PAS in Previa
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Patients With Placenta Previa
- ClinicalTrials.gov ID
- NCT07826247
- Acronym / sponsor ID
- Markers for PAS in Previa
- Conditions
- Placenta Accreta Spectrum, Placenta Previa
- Keywords
- Hematological markers, Coagulation markers, Complete blood count (CBC), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), D-dimer, Previous cesarean delivery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 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 a serious pregnancy complication where the placenta attaches too deeply into the wall of the uterus. This condition can lead to severe complications during delivery, including heavy bleeding, the need for blood transfusions, intensive care unit (ICU) admission, or the surgical removal of the uterus (hysterectomy).
Currently, doctors primarily use ultrasound to detect PAS before birth, but the accuracy of ultrasound can vary depending on the equipment and the doctor's experience. The main goal of this study is to determine if routine, simple blood tests can serve as an additional tool to help doctors predict which mothers are at the highest risk of developing PAS.
The study will involve pregnant women who have placenta previa (a low-lying placenta) and a history of a previous cesarean delivery. Researchers will collect a standard blood sample when the mother is admitted to the hospital to look at specific markers, including a complete blood count (CBC) and blood clotting (coagulation) factors.
By comparing these admission blood test results with the actual diagnosis of PAS confirmed during delivery, researchers hope to identify a reliable way to predict this condition. Improving the early detection of PAS could help medical teams better prepare for high-risk deliveries, optimize surgical planning, and ultimately improve health outcomes for mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Placenta Previa and Previous Cesarean Delivery | – | –This cohort consists of pregnant women aged 18 to 40 years with a singleton pregnancy at >28 weeks gestational age. Participants must be diagnosed with placenta previa via ultrasound, have a history of previous cesarean delivery, and be hemodynamically stable on admission. Participants will undergo an antenatal ultrasound to assess for signs of placenta accreta spectrum (PAS). Venous blood samples will be collected upon admission to evaluate complete blood count (CBC) parameters (including calculation of inflammatory indices like NLR, PLR, SII, and SIRI) and a coagulation profile (PT, PC, INR, aPTT, and D-dimer). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study population consists of pregnant women aged 18 to 40 years presenting to the Women's Health Hospital at Assiut University. Eligible participants must have a singleton pregnancy at a gestational age greater than 28 weeks, a diagnosis of placenta previa confirmed by ultrasound, a history of previous cesarean delivery, and be hemodynamically stable upon admission. Patients will be excluded if they present with intrauterine fetal demise (IUFD), intrauterine growth restriction (IUGR), premature rupture of membranes (PROM), chorioamnionitis, known blood diseases or bleeding tendencies, hypertension, or diabetes mellitus.
Key inclusion criteria (6 listed)
- Age: 18-40 years
- Placenta previa diagnosed by ultrasound
- Singleton pregnancy
- Gestational age >28 weeks
- Previous cesarean delivery
Key exclusion criteria (7 listed)
- Intrauterine fetal demise (IUFD)
- Intrauterine growth restriction (IUGR)
- Premature rupture of membranes (PROM)
- Chorioamnionitis
- Patients with known blood disease or bleeding tendency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Time frame: Within 12 weeks of enrollment
Evaluation of the predictive value of the maternal Systemic Immune-Inflammation Index (SII) for diagnosing placenta accreta spectrum (PAS). The SII is calculated from the complete blood count (neutrophils × platelets / lymphocytes) collected on hospital admission. Diagnostic accuracy will be quantified using the Area Under the Receiver Operating Characteristic (ROC) curve to determine the optimal cut-off point, sensitivity, and specificity. The reference standard diagnosis of PAS is confirmed via intraoperative assessment at the time of delivery.
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 17 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta Spectrum and Placenta Previa, run by Assiut University.
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 6 inclusion and 7 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum (time frame: Within 12 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.