Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

13. september 2026 oppdatert av: Mariam Khalifa Abdelnour Dous, Assiut University

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.

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Observasjonsmessig

Registrering (Antatt)

130

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic Accuracy of the Systemic Immune-Inflammation Index (SII) for Predicting Placenta Accreta Spectrum
Tidsramme: 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.
Within 12 weeks of enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

13. september 2026

Først innsendt som oppfylte QC-kriteriene

13. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere