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CTRI Number  CTRI/2025/03/083106 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study looking at what increases the risk of high blood pressure during pregnancy and how medicines are used to manage it 
Scientific Title of Study   A prospective observational study on risk factors and drug utilization patterns in women with pregnancy induced hypertension 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/BU/157/Faculty/11/321/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Smruti Vaishnav 
Designation  Professor and Consultant in the Department of Obstetrics and Gynecology. 
Affiliation  Pramukh Swami Medical College and Shree Krishna Hospital. 
Address  Pramukh Swami Medical College and Shree Krishna Hospital are located in Gokal Nagar, Karamsad, Gujarat,388325.

Anand
GUJARAT
388325
India 
Phone  8980809523  
Fax    
Email  smrutiv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Punit Joshi  
Designation  Research Scholar 
Affiliation  Anand Pharmacy College 
Address  Anand Pharmacy college, Opp. Town hall Anand

Anand
GUJARAT
388001
India 
Phone  9820162313  
Fax    
Email  punitbjoshi52@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Smruti Vaishnav 
Designation  Professor and Consultant in the Department of Obstetrics and Gynecology. 
Affiliation  Pramukh Swami Medical College and Shree Krishna Hospital. 
Address  ramukh Swami Medical College and Shree Krishna Hospital are located in Gokal Nagar, Karamsad, Gujarat,388325.

Anand
GUJARAT
388325
India 
Phone  8980809523  
Fax    
Email  smrutiv@charutarhealth.org  
 
Source of Monetary or Material Support  
Pramukhswami Medical college and Shree Krishna Hospital Bhaikaka university Karamsad Anand Gujarat 
 
Primary Sponsor  
Name  Dr Smruti Vaishnav 
Address  Pramukh Swami Medical College and Shree Krishna Hospital are located in Gokal Nagar, Karamsad, Gujarat,388325.  
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 Smruti Vaishnav  Shree Krishna Hospital   Department of Obstetrics and Gynecology
Anand
GUJARAT 
8980809523

smrutiv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee - 2 Hm Patel center for medical care and education Karamsad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O134||Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women diagnosed with pregnancy induced hypertension, Patient giving consent 
 
ExclusionCriteria 
Details  Patient age less than 18 years, Pregnant women not diagnosed with pregnancy induced hypertension, Patient not giving consent 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify and analyze risk factors associated with Pregnancy Induced Hypertension.
To characterize and evaluate the drug utilization patterns associated with Pregnancy Induced Hypertension.
 
6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate relative adverse events associated with Pregnancy Induced Hypertension.  6 MONTHS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/03/2025 
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="0"
Months="6"
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  

1.  Identification of Risk Factors: Recognizing and comprehending the risk factors linked to pregnancy induced hypertension can help detect at risk women in their early stages. Several factors have been linked to pre-eclampsia or hypertension in prior pregnancies, obesity, numerous gestations, and advanced maternal age. Improved risk stratification and focused interventions are made possible by a thorough investigation that can confirm these risk variables and uncover new ones.

2.  Management and Drug Utilization: The treatment of pregnancy induced hypertension frequently includes the use of antihypertensive medicines and other therapeutic approaches. Analyzing drug use trends can show existing procedures, compliance with guidelines, and places for improvement. This can lead to more effective treatment methods that improve mother and fetal health.

3.  Comparative Analysis of PIH Types: This study will look at gestational hypertension, pre-eclampsia (with and without proteinuria), and eclampsia (with convulsions) to see how they differ in risk factors, progression, and management needs. This distinction is critical for customizing individual treatment approaches to each kind of pregnancy induced hypertension.

4.  Outcome Improvement: The ultimate purpose of this study is to enhance clinical outcomes for women with pregnancy induced hypertension. Healthcare practitioners can design more effective prevention and management strategies by understanding risk factors and drug consumption patterns, lowering the occurrence of serious problems and improving the general health of pregnant women and their newborns.

 
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