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临床试验/CTRI/2025/06/089589
CTRI/2025/06/089589尚未招募不适用

Correlation of Placenta Accreta Score with Placental Volume and Angiogenic Markers

Department of Obstetrics and Gynaecology PGIMER1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
correlate placental volume and values of angiogenic markers (PlGF, SFLT, and, VEGF) with the placenta accreta score.

研究概览

简要总结

In this observational study, we will recruit 40 pregnant women under 40 years of age, each at least 32 weeks gestational age and having had at least one previous cesarean section. Participants will be enrolled from the outpatient department or labor ward of the Obstetrics and Gynaecology Department at PGIMER after completing detailed history-taking, clinical examination, and ultrasound, and after providing informed consent. The study will commence only after receiving approval from the Institute Ethics Committee, with collaboration from the Departments of Radiodiagnosis and Pathology.

Exclusion criteria include hemoglobinopathies or other hematological disorders, multiple gestations, cases requiring urgent surgical intervention before complete evaluation, and individuals unwilling to participate.

The study cohort will consist of two equal groups:

Placenta accreta group: 20 women diagnosed using PAS scoring, at 32–36 weeks gestation (mean ~34 weeks).

Control group: 20 women with at least one prior cesarean section, at 32–40 weeks gestation (mean ~36 weeks).

Both groups will be matched for age, parity (gravida), and weight. Hematologic parameters will be collected at admission, on the day of surgery (day 0), and on post-operative day 2. Angiogenic markers will be measured on the day of delivery for all participants. Placental volume will be assessed at enrollment using 3D ultrasonography performed by an expert.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Placenta Accreta Score group with age less than 40 years, POG more than 32 weeks, and features of accreta on the ultrasonography control group with age less than 40 years,POG more than 32 weeks and at least 1 previous LSCS.

排除标准

  • Women in both placenta accreta and control pregnancy group with hemoglobinopathies and other associated causes, multiple gestation, requiring urgent surgical intervention leaving inadequate time for evaluation and refusal to give consent.

结局指标

主要结局

correlate placental volume and values of angiogenic markers (PlGF, SFLT, and, VEGF) with the placenta accreta score.

时间窗: 12 months

次要结局

  • note the type of placental invasion assessed intraoperatively(12 months)
  • compare levels of hemoglobin & coagulation profile with the placental volume & angiogenic markers preoperatively & postoperatively among the women with placenta accreta & control group.(12 months)

研究者

发起方
Department of Obstetrics and Gynaecology PGIMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Deepak Yadav

Post Graduate Institute of Medical Education and Research

研究点 (1)

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