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临床试验/CTRI/2020/07/026623
CTRI/2020/07/026623尚未招募不适用

Study of Hematological Indices as predictors of Pre-eclampsia

All India Institute Of Medical Sciences Raipur1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2020年7月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
270
试验地点
1
主要终点
To study the role of the Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet Volume, Platelet distribution width, Red cell Distribution Width and Delta Neutrophil Index as predictors of pre-eclampsia.

研究概览

简要总结

Preeclampsiais associated with increased maternal and fetal morbidity. Activation ofinflammatory responses leads to widespread endothelial dysfunction andresultant manifestations of multi organ dysfunction in Preeclampsia. Earlyrecognition of Preeclampsia and its severity will help in guiding optimalobstetric management in pregnant women. Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet tolymphocyte ratio, Mean Platelet volume, Platelet distribution width,Plateletcrit, Red cell Distribution Width and Delta Neutrophil Index,givesan insight to the underlying inflammation in Preeclampsia.

These indices can be used as an emerging toolin prediction of pre-eclampsia as well as a marker is estimating the severityof pre-eclampsia. Its predictive value could be used for early diagnosis,timely referral and intervention to avoid life-threatening complication ofpre-eclampsia.

Moreover,these indices are easy, inexpensive to measure, reproducible and can be used asa marker of underlying inflammation in preeclampsia.

Therehas been small number of researches on the use of these indices to predictpre-eclampsia as well as severity of pre-eclampsia. Therefore, the presentstudy aims to study the role of hematological indices such as Neutrophil to Lymphocyte ratio, Plateletto lymphocyte ratio, Mean Platelet volume, Platelet distribution width,Plateletcrit, Red cell Distribution Width and Delta Neutrophil Index,  as predictors of pre-eclampsia.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Pregnant women of age 18-40years, with singleton pregnancy and 13-20 weeks gestational age, attending antenatal care: Outpatient department (OPD) and/or Inpatient department (IPD) in department of Obstetrics and Gynecology at All India Institute of Medical Sciences, Raipur and giving fully valid consent to participate in the study.

排除标准

  • â—Age < 18 years and > 40 years â—Multi fetal pregnancy â—Women who have co existing medical illness oChronic Hypertension oDiabetes mellitus oChronic liver disease oChronic Kidney disease oEstablished Cardiovascular disease oCollagen vascular disease oHematological disease oOngoing infection or systemic inflammatory conditions oAutoimmune disease â—History of Smoking, alcoholism and drug abuse â—Pregnancy complications like membrane rupture or intrauterine fetal death â—History of fever, HELLP.
  • â—Patient refusal to participate in study.

结局指标

主要结局

To study the role of the Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet Volume, Platelet distribution width, Red cell Distribution Width and Delta Neutrophil Index as predictors of pre-eclampsia.

时间窗: from the time of recruitment till 6 weeks postpartum

次要结局

  • a) To study the role of Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet Volume, Platelet distribution width, Red cell Distribution Width and Delta Neutrophil Index as markers of severity in women with pre-eclampsia.(b) To determine the diagnostic accuracy of Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio for the diagnosis of severe and non-severe pre-eclampsia.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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Hematological Indices in Pre-eclampsia | 临床试验