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CTRI Number  CTRI/2025/10/095739 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   STUDY TO PROVE THE GESTOSIS SCORE AS A PREDICTOR FOR PREGNANCY INDUCED HYPERTENSION AND OBSERVE THE MODE OF DELIVERIES OF SUCH CASES AND NOTE THE MATERNAL AND FETAL OUTCOMES OF THE SAME CASES 
Scientific Title of Study   VALIDITY OF GESTOSIS SCORE AS A PREDICTOR OF PREGNANCY INDUCED HYPERTENSION AND IT’S CORRELATION WITH MODE OF DELIVERY AND FETO- MATERNAL OUTCOMES- A PROSPECTIVE STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR TAERA DASTUR 
Designation  POST GRADUATE 
Affiliation  SHRI B M PATIL (DEEMED TO BE) MEDICAL COLLEGE, HOSPITAL RESEARCH CENTRE  
Address  SHRI B M PATIL ( DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE OPD ROOM NO 2 BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPURA KARNATAKA 586103 INDIA

Bijapur
KARNATAKA
586103
India 
Phone  9920056765  
Fax    
Email  taerafdastur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHAILAJA R BIDRI 
Designation  PROFESSOR AND HOD DEPARTMENT OF OBG  
Affiliation  SHRI B M PATIL (DEEMED TO BE) MEDICAL COLLEGE, HOSPITAL RESEARCH CENTRE  
Address  SHRI B M PATIL ( DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE OPD ROOM NO 2 BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPURA KARNATAKA 586103 INDIA

Bijapur
KARNATAKA
586103
India 
Phone  9880162550  
Fax    
Email  drsrbidri1@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR TAERA DASTUR 
Designation  POST GRADUATE 
Affiliation  SHRI B M PATIL (DEEMED TO BE) MEDICAL COLLEGE, HOSPITAL RESEARCH CENTRE  
Address  SHRI B M PATIL ( DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE OPD ROOM NO 2 BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPURA KARNATAKA 586103 INDIA

Bijapur
KARNATAKA
586103
India 
Phone  9920056765  
Fax    
Email  taerafdastur@gmail.com  
 
Source of Monetary or Material Support  
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA KARNATAKA INDIA 586103 
 
Primary Sponsor  
Name  SHRI B M PATIL (DEEMED TO BE) MEDICAL COLLEGE, HOSPITAL RESEARCH CENTRE  
Address  OBG OPD NO 2 SHRI B M PATIL (DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPURA 586103 
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 
DR TAERA DASTUR  SHRI B M PATIL(DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE VIJAYAPURA  DEPARTMENT OF OBG SHRI B M PATIL ( DEEMED TO BE) MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE OPD ROOM NO 2 BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPURA KARNATAKA 586103 INDIA
Bijapur
KARNATAKA 		 9920056765

taerafdastur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA BLDE (DU) IEC-SBMPMC/326/2024-25  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  PREGNANT WOMEN WITH GESTATIONAL AGE OF GREATER THAN 28 WEEKS
ANTENATAL WOMEN WITH PREGNANCY INDUCED HYPERTENSION AS DEFINED BY ACOG CRITERIA AS GROUP A
ANTENATAL WOMEN WITH NORMAL BLOOD PRESSURE AS GROUP B  
 
ExclusionCriteria 
Details  ANTENATAL WOMEN WHO ARE KNOWN CASES OF HYPERTENSION AND ON REGULAR MEDICATION FOR THE SAME
ANTENATAL WOMEN WHO ARE KNOWN SMOKERS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO VALIDATE GESTOSIS SCORE AS AN EARLY PREDICTOR FOR PREGNANCY INDUCED HYPERTENSION   THE ASSESMENT IS DONE AT THE TIME OF ADMISSION TO LABOUR ROOM AT THE BASELINE  
 
Secondary Outcome  
Outcome  TimePoints 
TO ANALYSE VARIOUS RISK FACTORS COMPRISING THE SCORE AND ITS CORRELATION TO THE CAUSATION OF PIH   THE ASSESMENT IS DONE AT THE TIME OF ADMISSION TO LABOUR ROOM AT THE BASELINE  
TO OBSERVE THE MODE OF DELIVERY AND FETAL OUTCOMES INCLUDING MORTALITY MATURITY BIRTH WEIGHT AND NICU ADMISSION   THE ASSESMENT IS DONE AT THE TIME OF WHEN THE DELIVERY OR SECTION TAKES PLACE AT THE
BASELINE AND THE BABY DETAILS ARE COLLECTED INSTANTLY AFTER BIRTH AND INITIAL ASSESSMENT OF THE BABY  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/10/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [taerafdastur@gmail.com].

  6. For how long will this data be available start date provided 11-06-2025 and end date provided 11-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Pregnant women with a period of gestation greater than 28 weeks and within the age group ranging from 18 to 40 years who are admitted to the Labor Ward and willing to give written and informed consent as per the inclusion and exclusion criteria are taken for this study
The patients are divided into two groups namely Group A are those who have developed pregnancy induced hypertension according to the ACOG Criteria
Group B are those patients who are normotensive
Both the groups are evaluated by taking a detailed history as enlisted in the Gestosis score while considering the severity so as to give an appropriate score ranging from 1 to 3
Further detailed examination was done to obtain blood pressure MAP and body mass index based on height and weight.
Investigations like complete blood count thyroid profile and oral glucose challenge test reports were used for thorough evaluation of the patients
After obtaining the total score comparison is made with the diagnosis of the patient at the time of admission and the result is noted indicating whether the patient had a score of 3 and above developed preeclampsia or vice versa
Next details of the mode of delivery and fetal outcomes are observed
The fetal outcomes include mortality maturity birth weight and NICU admissions
 
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