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CTRI Number  CTRI/2025/08/092788 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study Of Blood Pressure Medicines And Assessment Of Mother And Newborn Outcomes In Pregnant Women With Hypertension. 
Scientific Title of Study   Prescription Pattern Of Antihypertensive Medications And Assessment Of Maternal And Neonatal Outcomes In Pregnant Women With Hypertension: A Retrospective Observational 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  Ashika Abubakkar Ahmed 
Designation  PG Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practices , NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University),Paneer,Deralakatte,Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8147252861  
Fax    
Email  ashikaahmed183@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practices , NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University),Paneer,Deralakatte,Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practices , NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University),Paneer,Deralakatte,Mangaluru


KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice ,NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University),Paneer , Deralakatte , Mangaluru -575018 
Justice K S Hegde Charitable Hospital , Deralakatte , Mangaluru , Karnataka -575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice ,NGSM Institute of Pharmaceutical Sciences (Nitte Deemed to be University), Paneer , Deralakatte , Mangaluru -575018 
Type of Sponsor  Other [Academic Institute] 
 
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 Roopa Satyanarayan Basutkar  Justice K S Hegde Charitable Hospital   Department of Obstetrics and Gynecology,Justice K S Hegde Charitable Hospital, Deralakatte ,Mangaluru
Dakshina Kannada
KARNATAKA 
9047155003

roopa.satyanarayan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGMIPS Institute of Pharmaceutical Sciences Institutional Ethics Committee(NGSMIPS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O169||Unspecified maternal hypertension,unspecified trimester,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Age greater than and equal to 18years
Pregnant patients with hypertension
Singleton pregnancies
Women receiving antenatal care at the study hospital 
 
ExclusionCriteria 
Details  Multiple pregnancies (twins or more)
With comorbidities (diabetes mellitus) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To provide insights into prescribing trends based on gestational age and severity of hypertension.  Eight Months 
 
Secondary Outcome  
Outcome  TimePoints 
To recognize the maternal and neonatal outcomes among pregnant women with hypertension .  Eight Months 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   31/08/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Hypertension in pregnancy, also known as hypertensive disorders of pregnancy (HDP), is defined as a systolic blood pressure of 140 mmHg or higher and/or a diastolic blood pressure of 90 mmHg or higher. It is associated with adverse maternal and neonatal outcomes including preterm delivery, low birth weight, increased rates of cesarean section and neonatal intensive care unit (NICU) admissions. Timely identification and management of hypertension are crucial to prevent complications. However, there is limited focused research on maternal and neonatal outcomes among hypertensive pregnant women. The aim of the study is to analyze the prescription pattern of antihypertensive medications to understand the safer and more effective treatment strategies during pregnancy and to assess maternal and neonatal outcomes among pregnant women with hypertension .The objective of the research is to study the prescription pattern of antihypertensive medications and to assess the maternal and neonatal outcomes among pregnant women with hypertension . A retrospective observational study will be conducted over a period of 8 months. Patients aged greater than and equal to 18 years with singleton pregnancies diagnosed with hypertension and received antenatal care at the study hospital will be included. Data will be collected retrospectively from the Medical Records Department of Justice K.S. Hegde Charitable Hospital, covering the period from January 2022 to December 2024. Statistical analysis will be done using SPSS software version 29 .This study will give overview of prescription pattern of antihypertensive medications and assessment of the maternal and neonatal outcomes in pregnant women with hypertension , thereby contributing to improved antenatal care, risk assessment, and management strategies for affected mothers and their newborns.

 
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