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CTRI Number  CTRI/2025/03/081803 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational study to gauge the effect of preeclampsia on the immune system of the baby 
Scientific Title of Study   EFFECT OF PREECLAMPSIA INDUCED PRENATAL HYPOXIA ON INFANT T REGULATORY CELL RELATED GENE EXPRESSION 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mallanagouda M Patil 
Designation  Professor and HOD 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre, BLDE (DU) 
Address  Dept. of Paediatrics, Shri B M Patil Medical College Hospital and Research Centre BLDE Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  9900291825  
Fax    
Email  mm.patil@bldedu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Mallanagouda M Patil 
Designation  Professor and HOD 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre 
Address  Dept. of Paediatrics, Shri B M Patil Medical College Hospital and Research Centre BLDE Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  9900291825  
Fax    
Email  mm.patil@bldedu.ac.in  
 
Details of Contact Person
Public Query  
Name  Mallanagouda M Patil 
Designation  Professor and HOD 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre 
Address  Dept. of Paediatrics, Shri B M Patil Medical College Hospital and Research Centre BLDE Vijayapura

Bijapur
KARNATAKA
586103
India 
Phone  9900291825  
Fax    
Email  mm.patil@bldedu.ac.in  
 
Source of Monetary or Material Support  
ICMR, New Delhi 
 
Primary Sponsor  
Name  ICMR 
Address  ICMR, New Delhi 
Type of Sponsor  Government funding agency 
 
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 
Yashwanth Yellanki  Shri B M Patil Medical Collage Hospital and Research Centre, BLDE(DU)  No. 102, Labour Room, Dept of Obstetrics and Gynaecology
Bijapur
KARNATAKA 		 9398224116

yellankirr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, SBMPMC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  10.00 Day(s)
Gender  Both 
Details  Inclusion Criteria for mothers: All consenting primiparous mothers, 18-40yrs old diagnosed with preeclampsia according to ISSHP guidelines 2021, undergoing elective caesarean section between 37 weeks to 40 weeks of gestation in hospital will be included in the study.
Inclusion Criteria for infant : All infants born to consenting primiparous mothers, 18-40yrs old diagnosed with preeclampsia according to ISSHP guidelines 2021, undergoing elective caesarean section between 37 weeks to 40 weeks of gestation in hospital will be included in the study.
 
 
ExclusionCriteria 
Details  Exclusion Criteria for mother:
Mothers not willing to give consent.
Deliveries of unknown gestational age.
Mothers with pre-existing chronic hypertension, chronic diabetes and other chronic illnesses.
Exclusion Criteria for infant :
Infants with obvious congenital anomalies.
Infants suffering from meconium aspiration syndrome
Infants with intrauterine growth restriction (IUGR) not related to pregnancy induced hypertension (PIH).

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of preeclampsia induced prenatal hypoxia on T Regulatory cell-related gene expression in the infant cord blood.
 		 Immediately at birth
 
 
Secondary Outcome  
Outcome  TimePoints 
To find a correlation between PO2, PCO2, lactate levels, bicarbonate levels & FOXP3, CTLA4 & GATA3 gene expression.  Immediately at birth 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2025 
Date of Study Completion (India) 30/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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   Introduction : 

Preeclampsia with a prevalence of 0.2 to 6.7 % in Asia, is an important pregnancy related hypertensive disorder which contributes to pregnancy related morbidity and mortality and long term complications for both the mother and the child. Clinically preeclampsia presents as increased blood pressure and proteinuria. This is a result of abnormal placentation and improper adhesion of the trophoblasts leading to reduced maternal blood flow. Exposure to preeclampsia is associated with poorer outcomes for the infant in the postnatal period such as low birth weight and lower APGAR scores. This is primarily due to decreased blood circulation leading to prenatal hypoxia.

Studies have found that decreased T regulatory cells (Treg) population in uterine tissue is associated with preeclampsia.


Treg cells play an important role in facilitating implantation, mediating foetal tolerance. They  also play an important role in the pathogenesis of many autoimmune and inflammatory disorders. Treg cell expression is characterised primarily by expression of transcription factor FOXP3 followed by related genes including CTLA4 and GATA3 essential for induction and maintenance of FOXP3 expression.

 

In cases of exposure to hypoxia, the infant immune landscape may be adversely affected because of the induction of factors associated with hypoxia potentially leading to a generally increased inflammatory profile. The exact effect of prenatal hypoxia on the expression of FOXP3 and other immune markers associated with Treg cells is still not completely understood.(11) It is important to identify the effect of hypoxic conditions on the infants genes related to Treg development and function. Dysregulation of these gene expressions may potentially lead to increased susceptibility to autoimmune conditions. Through our study we would like to understand this aspect of preeclampsia complicated pregnancy. The study of genes associated with Treg cells other than FOXP3 will further provide novel insights into the molecular mechanisms in action

Objective 

  1. To determine the effect of preeclampsia induced prenatal hypoxia on T Regulatory cell-related gene expression in the infant cord blood.

2. To find a correlation between PO2, PCO2, lactate levels, bicarbonate levels and FOXP3, CTLA4 and GATA3 gene expression.

The results obtained through this study will help us better understand the immune dysregulation of the infant caused by exposure to prenatal hypoxia due to preeclampsia. By investigating impaired Treg cell expression, we can better understand its link to autoimmune disorders. This study provides novel insights into preeclampsia and will further lead to identification of future therapeutic targets for treatment of prenatal hypoxia related immune dysregulation in the infant. The results will inform public health policy in regard to maternal and child health and guide future research in this area. 


 
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