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临床试验/CTRI/2025/09/094823
CTRI/2025/09/094823尚未招募不适用

A comparative study of oxidative stress in anemic and non-anemic pregnant women receiving oral iron supplements in a Tertiary Care Hospital in Belagavi

Dr Mansa Priyadarshini1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年9月26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
140
试验地点
1
主要终点
Oxidative stress in anemic and nonanemic pregnant women due to iron supplementation

研究概览

简要总结

Need for the study-

Pregnancy is a state of negative iron balance. Iron is required for increased demand of pregnancy which includes fetal growth and hematopoietic requirements in mother. Iron deficiency anemia is the most common nutritional deficiency among pregnant women. To combat the negative iron balance of pregnancy, prophylactic iron therapy is prescribed to the non-anemic pregnant women in routine practice. But the safety of uniform iron supplementation across all pregnant women is controversial. It has been observed in previous research that iron supplementation may cause oxidative stress in pregnancy. Both iron overload and iron deficiency could promote the generation of free radicals  and result in cellular damage. In pregnancy, iron supplementation has been observed to heighten the oxidative stress as evidenced by increased levels of Malondialdehyde (MDA) in the serum of mothers and the placenta. Prenatal iron supersaturation has also been associated with an elevated risk of miscarriage, prematurity, low birth weight, and being small for gestational age with oxidative stress identified as one of the potential underlying mechanism. High levels of haemoglobin, hematocrit, and ferritin are found to be associated with increased risk of fetal growth restriction, gestational diabetes mellitus, pre eclampsia, preterm labour. In pregnant women without iron deficiency anemia, prophylactic iron supplementation has been shown to induce oxidative stress and compromise the overall antioxidant capacity of the body. This has not been explored adequately in the recent times. Hence this study will be carried out with the objective of comparing oxidative stress among anemic and non-anemic antenatal women receiving oral iron supplements.

 Methodology: Singleton pregnant women between 14-20weeks of gestation will be  recruited from the outpatient department after written informed consent. They will be recruited under 2 groups anemic (Hb-7 to 10.9gm percent ) and non anemic (Hb greater than 11gm percent) .Non anemic women will be given oral iron which contains 60mg elemental iron once daily and anemic women will be given oral iron which contains 60mg elemental iron twice daily. They will also be given folic acid 5mg and calcium supplements. 5ml of blood will be collected from the study subjects out of which 2 ml will be transferred to EDTA tube to analyze hemoglobin, hematocrit and other red cell indices by fully automated cell counter analyzer and 3 ml to plain yellow capped tube to analyze biochemical parameters like Serum Ferritin by fully autoanalyzer (kit method). Levels of MDA by spectrophotometric method using TBRAS kit and Total Antioxidant Capacity (TAC) by ELISA will be measured at the start of study and 3-6 weeks later respectively. The study subjects will be enquired about the compliance and side effects of supplemented drugs, during their follow up visits.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women with singleton pregnancy with mild-moderate anemia (Hb 7-10.9gm percent) Non-anemic Pregnant women with singleton pregnancy Written informed consent.

排除标准

  • Pregnant women having 1.) Pre existing chronic diseases eg Diabetes Mellitus, Chronic Hypertension, Cardiovascular diseases, Chronic Kidney Disease, Thyroid disorders, Autoimmune disorders (eg- lupus, rheumatoid arthritis) 2.) Other Hematological disorders eg- Sickle cell anemia, Thalassemia, Hemolytic anemia, Bleeding disorders 3.) Severe infections or inflammatory conditions eg- Active infections like tuberculosis, HIV, hepatitis B/C 4.) Use of medications affecting oxidative stress or iron metabolism eg – Long term corticosteroids, Antioxidant supplements (like vitamin C, E), Anti-inflammatory drugs (NSAID’s or immunosuppresants), Anti epileptic drugs, Chemotherapy drugs, Antiretroviral drugs, Antibiotics (Gentamicin, Metronidazole), Antacids, chelating agents, anticoagulants, aspirin, zinc and copper supplements 5.) Multiple pregnancy 6.) Iron overload disorders (eg- hemochromatosis) 7.) Smoking, Alcohol, Drug abuse 8.) Severe malnutrition or dietary restrictions (BMI smaller than 18.5kg/m2-underweight) 9.) Obese (BMI greater than 30kg/m2) 10.) Refusal to give consent.

结局指标

主要结局

Oxidative stress in anemic and nonanemic pregnant women due to iron supplementation

时间窗: At 14-20wks (Before starting iron supplementation) and | 3-6 wks after starting iron supplementation

次要结局

未报告次要终点

研究者

发起方
Dr Mansa Priyadarshini
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mansa Priyadarshini

Jawaharlal Nehru Medical College, KLE University, Belagavi

研究点 (1)

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