| 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
|
|
|
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
|
|
|
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. |