Evaluation of the effect of Low dose Aspirin on plasma concentration of Neurofilament Light Chain (NfL) in moderate to high risk preeclampsia patients compared to low risk pregnant females and to correlate NfL levels with maternal and fetal outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Serum concentration of NfL in moderate to high risk patients and low risk patients of pre-eclampsia
研究概览
简要总结
Pre-Eclampsia is a hypertensive disorder developing in pregnant females after 20 weeks of gestation. It is defined as blood pressure more than 140/90 mm hg in patients with previously normal blood pressure readings. End organ damage is also seen in this condition which can affect major organ systems like kidney, liver and brain. The estimated prevalence in India is 10% and is a major cause of morbidity and mortality.
Patients are screened for risk of pre-eclampsia according to India guidelines issued by FOGSI and are classified as low, moderate and high risk for pre-eclampsia. In moderate and high risk patients, low dose aspirin is started as a prophylactic measure. Currently, there is no pharmacological treatment of the disease and symptoms are managed accordingly using clinical, biochemical and radiological parameters. Once the disease develops, symptomatic treatment is done using lifestyle modification and pharmacological therapies with the only definitive treatment being termination of pregnancy. Due to the above reasons, patients are advised regular ANC visits for early detection and management.
This study aims to assess the effect of the prophylactic drug i.e aspirin on a predictive axonal biomarker Neurofilament Light Chain (NfL). The aforesaid biomarker will be evaluated during routine ANC checkup and extra 5 ml blood will be taken for the same. Furthermore, the biomarker levels will be correlated with clinical and radiological parameters to establish it’s role as a predictive biomarker for the disease of interest.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant patients classified as moderate to high risk for pre-eclampsia at 12-16 weeks of gestation according to FOGSI guidelines, to be started on aspirin prophylaxis by the attending obstetrician in the antenatal outpatient clinic.
- •Pregnant patients categorized as low risk of pre eclampsia at 12-16 weeks of gestation according to FOGSI guidelines by the attending obstetrician and not started on aspirin prophylaxis
- •Patients with age above 18 years
- •Intra uterine pregnancy
- •Patients planning to have delivery in KEM Hospital.
排除标准
- •Patients not willing to give informed consent
- •Patients admitted in IPD and emergency department for causes not related to pregnancy
- •Chronic Kidney Disease
- •Contraindication to Aspirin.
结局指标
主要结局
Serum concentration of NfL in moderate to high risk patients and low risk patients of pre-eclampsia
时间窗: 1. Baseline Value (Visit 0)- 12-16 weeks | 2. Visit 1- 24-26 weeks | 3. Visit 2- 32-34 weeks
次要结局
- Biochemical variables :(1. Proteinuria)
- Clinical Variables: Observe patients for the development of-(Maternal Clinical Outcomes:)
- Radiological variables:(Maternal (uterine artery doppler):)
- Correlation between Serum NfL levels with maternal clinical outcomes, fetal clinical outcomes, neonatal clinical outcomes and radiological parameters in low risk and moderate to high risk groups(Not Applicable)
研究者
Dr Sharmila Jalgaonkar
Seth GS Medical College and KEM Hospital
