| CTRI Number |
CTRI/2025/09/094041 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess the challenges faced by the pregnant women with high pressure |
|
Scientific Title of Study
|
Critical analysis of pregnancy induced hypertension in the context of three delays and its outcome among women admitted in a tertiary care hospital West Bengal |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shukla Banerjee Dey |
| Designation |
Senior Sister Tutor and PhD Scholar |
| Affiliation |
|
| Address |
Department of Nursing
Nursing Training School
NRS Medical College and Hospital
Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9903058465 |
| Fax |
|
| Email |
shukla18072010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Alpanamayi Bera |
| Designation |
Principal and Guide |
| Affiliation |
|
| Address |
Department of Nursing Principal Room 1st floor
Govt College of Nursing
Medical College and Hospital Kolkata
88 College Square Kolkata
Kolkata
WEST BENGAL
700073
India |
| Phone |
9831357924 |
| Fax |
|
| Email |
alpanamayi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Alpanamayi Bera |
| Designation |
Principal and Guide |
| Affiliation |
|
| Address |
Department of Nursing
Principal Room 1st floor
Govt College of Nursing
Medical College and Hospital Kolkata
88 College Square Kolkata
Kolkata
WEST BENGAL
700073
India |
| Phone |
9831357924 |
| Fax |
|
| Email |
alpanamayi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gynae and Obstetrics
Murshidabad Medical College and Hospital Berhampore Murshidabad
|
|
|
Primary Sponsor
|
| Name |
Shukla Banerjee Dey |
| Address |
Murshidabad Medical College and Hospital
73 Station Road Raninagar Gorabazar Berhampore West Bengal 742101 |
| 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 |
| Prof Dr Alpanamayi Bera |
Murshidabad Medical College and Hospital |
Department of Gynae and Obstetrics Matrimaa Building
73 Station Road Raninagar Gorabazar Berhampore West Bengal 742101
Murshidabad
WEST BENGAL |
9831357924
alpanamayi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Murshidabad Medical College and Hospital Berhampore Murshidabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O139||Gestational [pregnancy-induced] hypertension without significant proteinuria, unspecified trimester, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 Women who are willing to participate
2 Women who have delivered within 7 days in study hospital
3 Women who are resident of Murshidabad district |
|
| ExclusionCriteria |
| Details |
1 Women who are admitted for delivery from other states or districts
2 Women who have pre-existing hypertension before pregnancy
3 Women who are psychologically unstable |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Critical analysis of three delays as a framework of pregnancy induced hypertension among women ascertain whether the provision of health services influences decision making for seeking medical care |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
12/09/2025 |
| 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="4"
Months="0"
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
|
Critical analysis of pregnancy induced hypertension in the context of three delays and its outcome among women admitted in a tertiary care hospital will ascertain whether the provision of health services influence decision making for seeking medical care and the challenges faced by the women while accessing the care and the investigator also aims to investigate the factors associated with these delays considering the magnitude of this problem |