Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa

NCT07826247 | Not Yet Recruiting

• 1 other identifier: Markers for PAS in Previa
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 12 weeks of enrollment

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age: 18-40 years
• Placenta previa diagnosed by ultrasound
• Singleton pregnancy
• Gestational age \>28 weeks
• Previous cesarean delivery
• Hemodynamically stable on admission

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09