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临床试验/CTRI/2024/05/067148
CTRI/2024/05/067148尚未招募不适用

Comparison of Cord Blood Lipid Profile among Hypertensive and Normotensive Mothers: A one year case-control study at KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi

Divya Sinha1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月20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
100
试验地点
1
主要终点
Primary objective- To estimate the cord blood lipid profiles in hypertensive and normotensive mothers

研究概览

简要总结

Introduction and Need for the study “The Fetal Origin**of Adult Disease Hypothesis” first popularised by Dr David Barker, proposes a direct link between prenatal nutrition and late-onset coronary heart disease.It is hypothesized that the events occurring in the early placental and fetal development will have a profound effect on one’s risk for developing future adult diseases.The changes in maternal circulation will eventually be reflected on fetal circulation too.Hypertensive disorders in pregnancy are associated with changes in lipid profile which can be detected with cord blood sampling. There is placental dysfunction in pre-eclampsia leading to maternal endothelial dysfunction. Consequently, there will be oxidative stress, dyslipidemia and inflammation. A deranged fetal lipid profile, due to either genetic constitution or gestational nutrition or intrapartum stress can continue to adulthood. Cord blood dyslipidemia is not only a manifestation of pre-eclampsia and but may also play a role in its pathogenesis. Neonates born to hypertensive mothers (including pre-eclampsia) can be targeted and followed up to their adult life for occurrence of coronary artery diseases and dyslipidemia. Despite having a role in the pathogenesis of pre-eclampsia, there is a dearth of knowledge regarding the lipid metabolomics of the cord blood. The normal values of cord blood lipids are not available in our population. Hence, measuring the cord blood lipid profile is easy and feasible to detect the lipid levels at birth in newborns of hypertensive and normotensive mothers. Our study could contribute to developing primary prevention in pre-eclampsia by changing the lipid profiles in suspected mothers who are prone to develop pre-eclampsia. Data Collection Procedure An informed consent will be taken after screening for eligibility Total enrolled study participants will be allotted into group A and group B accordingly and matched according to the age, parity, socio-economic status and mode of delivery. 3 mL venous blood sample will be collected from the mother at the time of admission in plain bulb after admission to labor room/ward under aseptic precautionsand 5 mL of cord blood will be collected using clamping method from placental side of umbilical vein in plain bulb and sent to biochemistry laboratory for lipid profile analysis. After centrifugation, the serums obtained will be analysed for lipid profile by enzymatic method colorimetric method (Cobas Pro by Roche). The values of TC, TG, HDLc, LDLc and VLDLc will be compared of both mother and their baby in both the groups. The immediate maternal and fetal outcome will also be noted. Histopathology reports of placenta with membranes will also be collected of cases with deranged cord blood lipid profile

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Singleton term pregnancy
  • Group A- women with gestational hypertension, chronic hypertension with superimposed pre-eclampsia, pre-eclampsia, eclampsia
  • Group B- normotensive women.

排除标准

  • Mothers with pre-existing medical conditions such as cardiovascular disorders, diabetes mellitus, collagen vascular diseases, HIV positive on HAART, known familial dyslipidemia, known case of pre-pregnancy hypertension
  • Non-vigorous baby at birth
  • Still Birth
  • Intra-Uterine Demise.

结局指标

主要结局

Primary objective- To estimate the cord blood lipid profiles in hypertensive and normotensive mothers

时间窗: 37 weeks to 42 weeks

次要结局

  • Secondary objective- To assess cord blood lipid profiles in relation to immediate materno-fetal outcomes(37 weeks to 42 weeks)

研究者

发起方
Divya Sinha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Divya Sinha

Jawaharlal Nehru Medical College, Belagavi

研究点 (1)

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