FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094823 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparison of oxidative stress in anemic and non-anemic pregnant women receiving oral iron supplements in a Tertiary Care Hospital in Belagavi 
Scientific Title of Study   A comparative study of oxidative stress in anemic and non-anemic pregnant women receiving oral iron supplements in a Tertiary Care Hospital in Belagavi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansa Priyadarshini 
Designation  Junior Resident Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, KLE University, Belagavi 
Address  Room no 622, New PG Girls Hostel, JNMC campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  6360934989  
Fax    
Email  mansapriyadarshini78@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Romana Khursheed 
Designation  Professor, Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, KLE University, Belagavi 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964892744  
Fax    
Email  romiarif@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mansa Priyadarshini 
Designation  Junior Resident Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, KLE University, Belagavi 
Address  Room no 622, New PG Girls Hostel, JNMC campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  6360934989  
Fax    
Email  mansapriyadarshini78@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore Charitable Hospital, Belagavi-590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr Mansa Priyadarshini 
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Belagavi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mansa Priyadarshini  KLEs Dr Prabhakar Kore Charitable Hospital  Department of Obstetrics and Gynaecology and Department of Biochemistry, Jawaharlal Nehru Medical College, Belagavi-590010
Belgaum
KARNATAKA 
6360934989

mansapriyadarshini78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anemic pregnant women taking iron supplements  Anemic (Hb-7-10.9gm percent) pregnant women will be given oral iron which contains 60mg elemental iron twice daily 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Comparator Agent  Non-anemic pregnant women taking iron supplements  Non-anemic pregnant women will be given oral iron which contains 60mg elemental iron once daily  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women with singleton pregnancy with mild-moderate anemia (Hb 7-10.9gm percent)

Non-anemic Pregnant women with singleton pregnancy

Written informed consent
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oxidative stress in anemic and nonanemic pregnant women due to iron supplementation  At 14-20wks (Before starting iron supplementation) and
3-6 wks after starting iron supplementation
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 

 
Close