| CTRI Number |
CTRI/2025/10/096258 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving the outcomes of moms and babies health by giving complete nurse supported care during pregnancy for high blood pressure pregnant women from 5th month. |
|
Scientific Title of Study
|
A Study Of Impact Of Comprehensive Vascular Symptom Management For Pregnancy-
Induced Hypertension On Maternal Well Being And Neonatal Outcomes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaini PC |
| Designation |
Ph.D Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Ph.D section
Ground floor
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad
Uttar Pradesh
India
Ph.D section
Ground floor
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09818153579 |
| Fax |
|
| Email |
shaini.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaini PC |
| Designation |
Ph.D. Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
First floor
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad, Uttar Pradesh
India
First floor
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09818153579 |
| Fax |
|
| Email |
shaini.scholar@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shaini PC |
| Designation |
Ph.D Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
First floor
Ph.D section
College of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad, Uttar Pradesh
India
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad, Uttar Pradesh
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09818153579 |
| Fax |
|
| Email |
shaini.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shaini PC |
| Address |
First floor
College Of Nursing
Teerthanker Mahaveer University
Delhi Road
Moradabad, Uttar Pradesh
India
Pin 244001 |
| 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 Dheeraj Raj |
Lala Lajpat Rai Memorial Medical College & Associated Sardar Vallabh Bhai Patel Hospital |
Superintendent in chief
administrative department
First floor
Garh Road
Meerut
UP
250004
Meerut
UTTAR PRADESH |
9719626796
svbphospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTRE |
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 |
Comprehensive Vascular Symptom Management |
Comprehensive Vascular Symptom Management
A tailored program including
life style modifications
Medication Adherence Support
Regular blood pressure Monitoring
Vascular health assessment
Micro birth planning place and Mode of delivery and choosing companion to be present during delivery
The duration of the intervention will be 3 to 4 months up to delivery. |
| Intervention |
Comprehensive vascular Symptom Management |
CVSM contains life style modifications.Diet,mild exercises,medications,Regular antenatal visits ,micro Birth planning,regular monitoring etc |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
Standard Prenatal Care |
Routine Prenatal care and hypertension management as per existing guidelines |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women after 24 weeks (6months) of gestation
|
|
| ExclusionCriteria |
| Details |
Antenatal women before 24 weeks of gestation ,who have chronic hypertension ,critically ill or convulsions |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in maternal well being such as reduction in blood pressure decreased risk of complications and increased birth weight reduce risk of preterm labor distress |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life physical emotional
reduced risk hospitalization and of NICU admission |
6 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
10/11/2025 |
| 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
|
This is a randomized controlled double blinded parallel group trial evaluate the impact of comprehensive vascular symptom management intervention in anti natal women with pregnancy induced hypertension in three phases from second trimester to third trimester in 210 anti natal women in one setting in India The Primary outcome of the study is to reduced the blood pressure other symptoms and risk of complications both mother and neonate for six month duration The secondary outcomes will be the maternal well being and neonatal reduction of risk of admission in NICU and complications |