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临床试验/NCT06383923
NCT06383923招募中不适用

Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section:A Prospective Cohort Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Placenta Accreta Spectrum

研究概览

简要总结

  1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
  2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;
  3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease.

详细描述

The placenta accreta spectrum (PAS) is defined as abnormal placental trophoblast adherence with a wide range of myometrial invasion. It is a serious pregnancy complication that can lead to severe postpartum hemorrhage, which may necessitate hysterectomy, and could ultimately lead to maternal death.Previous studies have shown that women with the highest risk of PAS disorders are those with a prior cesarean section (CS) who present in the second trimester of pregnancy with any degree of placenta previa or low-lying placenta.PAS patients without prior CS represent about one-third of the entire PAS population.The strategy to identify at-risk patients without a prior CS has yet to be defined. This may lead to under identification of PAS patients without prior CS and create a missed opportunity to plan the delivery and improve prognosis in these women. Established risk factors distinct from prior CS delivery include in vitro fertilization (IVF), intrauterine implants, endometritis, uterine artery embolization manual placental removal, uterine malformation, adenomyosis, submucosal fibroids, smoking, maternal weight, maternal age, parity, and multifetal pregnancy. Large clinical studies focusing on PAS disorders in women without prior CS are, indeed, scarce.This study aims to explore the risk factors and prognosis of PAS without a history of cesarean section and try to establish the prediction model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women without prior cesarean section
  • Pregnant women who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024

排除标准

  • Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital
  • Pregnant women who gave birth at <28 weeks.

结局指标

主要结局

Placenta Accreta Spectrum

时间窗: 2 years

Clinical diagnosis and classification standards are based on the diagnostic standards recommended by FIGO in 2019

次要结局

  • Hemostatic measures(2 years)
  • Amount of bleeding(2 years)
  • hysterectomy(2 years)
  • blood transfusion volume(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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