Role of Iron Homeostasis and Vitamin D in Preeclampsia: A case-control study on Biochemical, Haematological, and Placental morphometric changes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- A comprehensive understanding of how iron and vitamin D are regulated in different pregnancy conditions, particularly preeclampsia and eclampsia.
研究概览
简要总结
Title: Role of Iron Homeostasis and Vitamin D in Preeclampsia: A Case-Control Study on Biochemical, Hematological, and Placental Morphometric Changes
Study Type: Case–control study
Study Setting & Duration: Central Lab, Manipal–Tata Medical College, Jamshedpur; sample collection from Mercy Hospital, Jamshedpur. Duration: 4 years
Background & Rationale: Preeclampsia and eclampsia are major pregnancy complications linked to hypertension and proteinuria, with adverse maternal–fetal outcomes. Iron metabolism regulators (hepcidin, erythroferrone) and vitamin D may influence disease development. Limited human data exist on their roles in preeclampsia, particularly in the Jharkhand population. This study will explore biochemical markers, iron regulation, vitamin D status, and placental morphology to better understand disease pathophysiology.
Objectives:
1. To measure BP, BMI, CBC, erythroferrone, hepcidin, ferritin, vitamin D, AST, ALT, uric acid, and proteinuria in preeclamptic women.
2. To study the relationship between placental morphometry and iron/vitamin D levels in preeclampsia.
3. To identify metabolic products in normotensive vs. preeclamptic pregnancies using GC–MS.
Study Population:
Cases: Pregnant women (18–35 years) diagnosed with preeclampsia/eclampsia.
Controls: Age-matched normotensive pregnant women.
Sample Size: 216 (108 cases, 108 controls; includes 10 percent attrition).
Inclusion Criteria:
Pregnant women aged 18–35 years
Diagnosed with preeclampsia/eclampsia (cases) or normotensive (controls)
Exclusion Criteria:
Pre-existing hypertension, type 2 or gestational diabetes, multiple pregnancy
Thyrotoxicosis, connective tissue diseases, pheochromocytoma
Blood transfusion during pregnancy, unwillingness to consent, or loss to follow-up
Methods:
Sample Collection: 5 mL venous blood; urine for proteinuria.
Biochemical Analyses: ELISA for erythroferrone, hepcidin, ferritin, vitamin D; CBC; inflammatory markers; uric acid, AST, ALT.
· Placental Morphometry: Weight, diameter, thickness, cotyledon count, surface area, and volume measurement post-delivery.
· Metabolomics: GC–MS analysis for metabolic profiling.
Data Analysis: SPSS v16 and GraphPad Prism 5 t-test and ANOVA p less than or equal to 0.05 significant.
Expected Outcomes & Significance: This study will clarify how iron metabolism and vitamin D status contribute to preeclampsia pathogenesis, and their relationship with placental structural changes. Findings could guide targeted supplementation and improved maternal–fetal care strategies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion Criteria: i.
- •Pregnant women aged between 18-35 years.
- •Preeclamptic and eclamptic women.
排除标准
- •Exclusion Criteria: i.
- •Pregnant women having Type II Diabetes mellitus, gestational diabetes mellitus ii.
- •Pregnant women with a hypertension history iii.
- •Pregnant women who are on antidepressive medication iv.
- •Thyrotoxicosis v.
- •Connective tissue disease-systemic lupus erythematosus vi.
- •Multiple pregnancy vii.
- •Pheochromocytoma viii.
- •Pregnant women who are not willing to give consent.
- •Failed to follow up x.
- •Pregnant women undergoing blood transfusion.
结局指标
主要结局
A comprehensive understanding of how iron and vitamin D are regulated in different pregnancy conditions, particularly preeclampsia and eclampsia.
时间窗: First trimester, Second trimester, and Third trimester
Understanding the metabolic changes and placental morphometry related to iron and vitamin D, providing better management strategies for maternal health.
时间窗: First trimester, Second trimester, and Third trimester
Identification of key metabolites or metabolic patterns that distinguish normotensive pregnancies, preeclampsia, and eclampsia and could reveal biomarkers associated with iron homeostasis, inflammation, or oxidative stress.
时间窗: First trimester, Second trimester, and Third trimester
次要结局
- Evidence-based recommendations to the policy makers.(First trimester, Second trimester, and Third trimester)
研究者
SWETANKA PRASAD
Manipal-Tata Medical College, Jamshedpur (A Constituent Unit of MAHE, Manipal)