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NCT Number: NCT06761885

Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarkers

To check if maternal serum (hcg _h ) in second and third trimester in pregnant woman with placenta previa can predict placenta accreta at delivery or predict adverse maternal and neonatal outcome

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Key information

About this study

Placenta accreta was first described in 1937 by Irving et al. as failure of separation of the placenta from the uterine wall following delivery of the human fetus leading to the often used term morbid placental adherence. The condition is characterised by invasive placentation which is associated with catastrophic haemorrhage. Varied terminology has been applied to this condition; however, recent guidelines suggested that placenta accreta spectrum (PAS), which includes accreta, increta, and percreta (defined below), be used going forward.The condition is unique to human pregnancy with no animal correlate reported in the literature.The incidence of PAS has increased substantially from 0.8 per 1000 deliveries in the 1980s to 3 per 1000 deliveries in the past decade, a phenomenon attributed to a rising global caesarean section rate . PAS is associated with significant maternal morbidity and mortality, in particular, major obstetric haemorrhage and peripartum hysterectomy . Mortality rates of up to 7% have been reported to be associated with PAS . The most recent confidential inquiry into maternal mortality in the United Kingdom (MMBRACE-UK, 2017) highlighted the continued high maternal mortality associated with the condition . The most important antenatal risk factor for PAS is the number of previous caesarean sections. In the presence of low-lying placenta (placenta previa) and three previous caesarean sections, a woman would have a 61% risk of PAS. Antenatal diagnosis is a key element to improving maternal and perinatal outcome . Although dedicated ultrasound and MRI having improved antenatal diagnosis, between one half and two thirds of cases remain undiagnosed, resulting in poorer maternal outcomes.For several years, investigators have attempted to identify maternal serum biomarkers that could be used to improve the accuracy of antenatal diagnosis of PAS. The use of ultrasound and MRI in the diagnosis of PAS has been extensively reviewed elsewhere . Several placental and fetal hormones routinely used in the screening for aneuploidy have been found to be differentially expressed in the serum of women with PAS compared with those with placenta previa . HCG is a glycoprotein composed of 244 amino acids with a molecular mass of 36.7 kDa that is produced by the syncytiotrophoblast and maintains pregnancy by stimulating progesterone synthesis by the corpus luteum. A maximum level of approximately 100,000 iu/l is reached by 8-10 weeks of gestation and declines as placental steroid synthesis commences .HCG is a heterodimeric molecule composed of an alpha subunit that is identical to luteinising hormone, follicle-stimulating hormone, and thyroid-stimulating hormone and a beta (β) subunit that is unique. Proteolytic cleavage by trophoblast macrophages destabilises the molecule, thereby producing free β-hCG that is secreted into the maternal circulation . Hyperglycosylated hcg is glycosylation variant of the hormone hcg .its different molecule to regional hcg as it produced by extravillous cytotrophoblastic cell (invasive trophoblast ) its function is invasive promoter as in implantation of pregnancy where it appears to promote cell proliferation ,invasion and implantation

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant woman
  • At least previous one CS
  • Gestational age at second and third trimester
  • Age (18:45) years

Exclusion criteria

  • proven fetal aneuploidy in current pregnancy

Treatment and study plan

Primary outcomes

  1. Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding

    Time frame: 12months

    Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Ahmed, Prof.Dr

CONTACT

[email protected]

01012588888

Esraa Mohammed, Resident

CONTACT

[email protected]

01220940533

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarker

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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