FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/083851 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to associate the iron profile values estimated during early pregnancy with the onset of hypertensive disorders of pregnancy  
Scientific Title of Study   A Prospective cohort study of Iron profile values estimated during early pregnancy and their correlation with the onset of hypertensive disorders of pregnancy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREE KAVYA MEDA 
Designation  POST GRADUATE(junior resident) 
Affiliation  SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  9441632874  
Fax    
Email  sreekavya1771@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NEELAMMA PATIL  
Designation  PROFESSOR 
Affiliation  SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura
OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura
Bijapur
KARNATAKA
586103
India 
Phone  9845068074  
Fax    
Email  neelamma.patil@bldedu.ac.in  
 
Details of Contact Person
Public Query
 
Name  SREE KAVYA MEDA 
Designation  POST GRADUATE(JUNIOR RESIDENT) 
Affiliation  SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura
OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura
Bijapur
KARNATAKA
586103
India 
Phone  09441632874  
Fax    
Email  sreekavya1771@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical College,Hospital and Research centre,Vijayapura ,Karnataka,586103,India 
 
Primary Sponsor  
Name  Shri B M Patil Medical College Hospital and Research centre 
Address  OBG Opd,Shri B M Patil Medical College Hospital and Research centre,Bangaramma Sajjan campus,Solapur road,Vijayapura,Karnataka,586103,India 
Type of Sponsor  Research institution and hospital 
 
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 SREE KAVYA MEDA  SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE   OBG OPD,Shri B M Patil Medical College Hospital And Research centre,Bangaramma Sajjan Campus,Vijayapura,Karnataka,586103,India
Bijapur
KARNATAKA 
09441632874

sreekavya1771@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(BLDE DEEMED TO BE UNIVERSITY)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O10-O16||Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  All singleton pregnant women within 18-30 age group with periods of gestation equal to or more than 12 weeks and less than or equal to 19 weeks and six days.
 
 
ExclusionCriteria 
Details  1.Chronic hypertensive patients
2.Known case of chronic infections.
3.Known case of malignancies.
4.Known case of Liver, Renal or cardiac disease.
5.Known case of hemochromatosis.
6.H/O past blood transfusions or parenteral iron infusions in the last 3 months.
7.Known case of hemoglobinopathies.
Pregnancy with anomalous babies.
8.H/O anemia with Hb less than 11g/dl
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To associate iron profile levels estimated during early
pregnancy with the onset of hypertensive disorders of pregnancy.
2.Gestational age at the time of development of hypertensive disorders of pregnancy.
pregnancy 
1.The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal outcome:
a] Gestational age at delivery
b] Mode of delivery
c] Any other outcomes
The neonatal outcome:
d] Weight
e] NICU admission
f] Neonatal death
 
The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy and the neonatal outcomes are recorded 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/04/2025 
Date of Study Completion (India) 30/09/2025 
Date of First Enrollment (Global)  12/04/2025 
Date of Study Completion (Global) 30/09/2025 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Preeclampsia is characterized by the onset of hypertension and proteinuria or other signs of end-organ dysfunction after 20 weeks of gestation in a previously normotensive patient. Its pathophysiology involves abnormal placentation, an imbalance of prostaglandins, inflammatory mediators, oxidative stress, and an imbalance of angiogenic and anti-angiogenic proteins.

Hypertension and anemia are the common medical complications of pregnancy that contribute  to maternal and perinatal mortality. So, identifying this condition as early as possible will bring a better outcome for pregnancy. Preeclampsia is defined as the new onset of hypertension and either proteinuria or other signs of end-organ dysfunction after 20 weeks of gestation in a previously normotensive patient.

The pathophysiology of preeclampsia is due to abnormal placentation, imbalance in different components of prostaglandins, inflammatory mediators, oxidative stress and  imbalance of angiogenic and anti-angiogenic proteins.

Iron is an important element that causes oxidative stress and damage to endothelial cells. The need of iron, increases during pregnancy, deficiency (levels below 9.5- 10.5gm/dl ) of   which leads to development of anemia and adverse maternal and fetal outcomes. And at the same time high serum iron levels are associated with preeclampsiaSerum ferritin is glycoprotein which is a primary form of iron storage and is the most effective indicator of iron status, in the absence of any infection or  inflammation. Studies done by

Zhuanji Fang et al,which is the only study available estimating serum ferritin levels during early pregnancy has found that the risk of pregnancy related hypertensive   disorders increase with increase in early pregnancy serum ferritin levels. 

Total iron binding capacity increases and transferrin saturation decreases with decrease in serum iron levels and thus is useful marker for detecting iron deficiency anemia.

Presently only one prospective study done by MaÅ‚gorzata Lewandowska et al, is available in which it was concluded that low serum iron levels  estimated during early   pregnancy were associated with preeclampsia.

Since the results were contradictory we would like to do a prospective study measuring the complete iron profile levels between 12-20 weeks of gestation to see what parameters correlates with development of preeclampsia.These parameters can also further be used as a biochemical predictor of preeclampsia and guide us regarding, whether  routine prophylactic supplementation of iron is to be done or not.

 
Close