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临床试验/CTRI/2023/10/059019
CTRI/2023/10/059019尚未招募不适用

EVALUATION OF miRNA - 210 AS PROGNOSTIC BIOMARKER OF PRE-ECLAMPSIA - A CASE CONTROL STUDY

DR KOTA SAI MEGHANA1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年10月30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
102
试验地点
1
主要终点
To determine the upregulation of miRNA 210 gene in pre-eclamptic women compared to normal healthy pregnant women

研究概览

简要总结

This case-control study will be done in the Department of Obstetrics and Gynaecology B.L.D.E

(DEEMED TO BE UNIVERSITY) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA, KARNATAKA, INDIA,  Any pregnant woman with BP >=140/90mmhg with two readings measured 6 hours apart, with significant proteinuria (≥300 mg of protein in a 24-h urine specimen or ≥1+ by dipstick) following 20 weeks of gestation in a previously normotensive woman will be considered in this study as GROUP 1.

GROUP 2 - considered are the normotensive pregnant women.

The Non- hypertensive pregnant women of the same gestational age are matched with pregnant women of the same gestational age and followed up till delivery. Age shall be matched with +/- 2 years, and gestational age shall be matched with +/-1 week.

Adverse outcomes if any, in the mother and fetus shall be recorded.

The primary outcome is to determine the upregulation of miRNA 210 gene expression in pre-eclamptic women compared to normal healthy pregnant women.

To correlate the severity of pre-eclampsia inpregnant women with gene expression.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1 Any pregnant woman with BP more than or equal to 140/90mmhg with two readings measured 6 hours apart with significant proteinuria (more than or equal to 300 mg of protein in a 24hr urine specimen or more than or equal to 1+ by dipstick) following 20 weeks of gestation in a previously normotensive woman 2Pregnant women age more than or equal to 18 3Singleton pregnancy 4Prenatal care at BLDE.

排除标准

  • 1 Any congenital fetal malformations or chromosomal abnormalities 2 Chronic Hypertension 3 Twins with pre eclampsia 4 Renal disease with pre eclampsia 5 Cardiac disease with pre eclampsia 6 Recent infection 7 APLA Syndrome.

结局指标

主要结局

To determine the upregulation of miRNA 210 gene in pre-eclamptic women compared to normal healthy pregnant women

时间窗: 2 years

次要结局

  • To correlate the severity of pre-eclampsia in pregnant women with the gene expression.(To correlate the fetal outcome with respect to fetal growth restriction, oligohydramnios, low birth weight, neonatal asphyxia, NICU admission.)

研究者

发起方
DR KOTA SAI MEGHANA
申办方类型
Other [self]

研究点 (1)

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