| 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
|
|
|
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
|
|
|
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. |