| 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
|
|
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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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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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 |
|
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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
|
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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 preeclampsia. Serum 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 Małgorzata 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. |