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临床试验/CTRI/2020/09/027531
CTRI/2020/09/027531尚未招募不适用

Evaluation of Leucocyte and Platelet indices in Preeclampsia compared to normotensive Asian Indian pregnant women

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月9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
- Values of NLR,MLR,PLR,MPV,PDW in patient of preeclampsia

研究概览

简要总结

Hyperactivation of inflammatory and immunologic responses in pre-eclampsia causes a marked increase in neutrophil count and modulation of neutrophil function toward greater production of superoxide compared with nitric oxide, which results in endothelial damage and dysfunction. Pre-eclampsia is also known to cause platelet activation, manifesting as low platelet count and high mean platelet volume (MPV).

Systemic immune inflammation indices derived from peripheral blood cells have recently attracted much attention because they are easily measurable and available. Abnormal changes in white blood cells counts have been observed in Preeclampsia, although the role of these systemic inflammatory indicators in clinical assessment, differential diagnosis and prognosis evaluation of PE remains unclear.

Hence this prospective comparative observational studyis being planned to assess the level of leucocyte and platelet indices in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to study the correlation of these indices with severity of preeclampsia as well as correlation  among various parameters as none of the previous prospective study has evaluated correlation between these indices.

The study group will comprise of 40 pregnant women aged 18–40 years who are diagnosed with pre-eclampsia (blood pressure elevation ≥140/90 mm Hg on two occasions 4 hours apart with proteinuria or any of the severe features of pre-eclampsia: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, cerebral or visual disturbances). 80 gestational age-matched, healthy pregnant women will be enrolled into the control group. In this study,  ratio of cases : controls will be maintained as 1:2; so as to get adequate representation among the controls and also to compensate for controls who will be likely to develop preeclampsia in the late stage of pregnancy, as such cases will be excluded from analysis. So sample size for cases and control will be 40 and 80 respectively.

Primary objectives of this study will be to assess the level of leucocyte and platelet indices (NLR, MLR, PLR, PDW, MPV) in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to correlate these indices with severity of preeclampsia

Secondary objectives will be to find the correlation among NLR, MLR, PLR, PDW, MPV; to correlate these markers with adverse feto-maternal and neonatal outcome; to evaluate other haematological markers such as RDW, Plateletcrit, absolute values of platelet count in preeclampsia.

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

  • Patients of preeclampsia meeting following criteria Systolic blood pressure>140 and/or DBP>90 mm of Hg on two occasions at least 4 hours apart; and proteinuria of >1+ on dipstick or 300 mg/day, after 20 week of gestation.

排除标准

  • Chronic hypertension Overt diabetes/GDM type A2 Renal Disease Fever within previous 1 week of diagnosis Collagen vascular disorder Rheumatoid arthritis Known autoimmune disorders.

结局指标

主要结局

- Values of NLR,MLR,PLR,MPV,PDW in patient of preeclampsia

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

NLR: Neutrophil to lymphocyte ratio

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

- Correlation of these markers with severity of preeclampsia

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

MLR: Monocyte to lymphocyte ratio

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

PLR: Platelet to lymphocyte ratio

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

MPV: Mean platelet volume

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

PDW: Platelet distribution width

时间窗: At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery

次要结局

  • 1.Maternal outcome: Eclampsia, HELLP syndrome, Mode of delivery(2.Fetal outcome: fetal growth restriction,intrauterine fetal death,prematurity and low birth weight)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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