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CTRI Number  CTRI/2019/01/016890 [Registered on: 03/01/2019] Trial Registered Prospectively
Last Modified On: 03/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of serum and placental levels of an enzyme (angiotensin-converting enzyme)and a vasodilator (nitric oxide) in preeclampsia patients 
Scientific Title of Study   Comparison and correlation of serum and placental levels of angiotensin-converting enzyme (ACE) and nitric oxide (NO) in preeclampsia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tilottama Chatterjee 
Designation  M.Sc student 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Biochemistry, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9923452263  
Fax    
Email  tilottama712@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Revathi P Shenoy 
Designation  Professor and Guide 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Biochemistry, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449367734  
Fax    
Email  revathi.shenoy@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Revathi P Shenoy 
Designation  Professor and Guide 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Biochemistry, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449367734  
Fax    
Email  revathi.shenoy@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, MAHE, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, MAHE, Manipal 
Type of Sponsor  Private medical college 
 
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 
Tilottama Chatterjee  Kasturba Hospital  Department of Obstetrics and Gynecology, Women and Childrens Block, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 9923452263

tilottama712@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Cases: Patients diagnosed with preeclampsia who are in their 3rd trimester of pregnancy
Controls: Healthy subjects in the 3rd trimester of pregnancy who do not exhibit symptoms of preeclampsia and gestational diabetes. 
 
ExclusionCriteria 
Details  Pregnant subjects showing complications such as gestational diabetes, hypertension, etc are excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference in levels of serum and placental angiotensin-converting enzyme (ACE) and nitric oxide (NO) between case and control groups  Samples are collected in 3rd trimester of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between serum ACE and NO
Correlation between placental ACE and NO 		 Samples are collected in 3rd trimester of pregnancy 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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)   15/01/2019 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Preeclampsia (PE) is a pregnancy-exclusive multi-system disorder complicating 5-7% of pregnancies and is one of the leading causes of feto-maternal morbidity and mortality worldwide. It is characterized as hypertension (>140/90mm Hg) after 20 weeks’ gestation, accompanied by proteinuria (>300 mg/l). Without sufficient changes in the uterine vasculature in early pregnancy, the placenta may become hypoxic with advancing gestation and suffer from oxygen deficiency at the tissue levels, and the supply of both nutrients and oxygen to the fetus is disturbed. Altered renin-angiotensin-aldosterone pathway metabolites- including angiotensin-converting enzyme (ACE) - generated within placental tissue, contribute to increased vasoconstriction, increase in tissue hypoxia and consequent lipid peroxidation seen in preeclampsia. This, in turn, could lead to a decrease in nitric oxide (NO) levels in the placental tissue, causing further vasoconstriction.

A similar mechanism, if occurring in the maternal circulation as well, could further explain the systemic vascular dysfunction observed in this condition. The aim of this study is to estimate the placental levels of ACE and NO, and serum levels of ACE and NO and compare them with an aim to elucidate the pathophysiology of preeclampsia. 

The study will be carried out in the Department of Biochemistry, KMC, MAHE. Ethical clearance was obtained from the Institutional Ethical Committee (IEC), following which 124 leftover blood samples will be collected after obtaining consent from subjects. Placental tissue samples will be collected from the same subjects following delivery. ACE will be measured in the serum and placental tissue homogenate using Hippuryl-Histidyl-Leucine (HHL) as substrate by a method modified from Cushman and Cheung. NO will be estimated in serum and placental homogenate using Griess reagent.

 
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