| CTRI Number |
CTRI/2018/04/013258 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
An experimental study to assess the effect of nursing interventional package on antenatal mothers |
|
Scientific Title of Study
|
An experimental study to assess the effectiveness of “Nursing Interventional Package on the management of pregnancy induced hypertension †on selected maternal, fetal and neonatal outcomes among antenatal mothers, attending antenatal clinic (ANC),PGIMER, Chandigarh, 2016-2018 |
| Trial Acronym |
EXP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KUMARI KHUSHBOO |
| Designation |
STUDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH |
| Address |
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH-160012,INDIA
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH-160012,INDIA
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8303918123 |
| Fax |
|
| Email |
khushboobhu510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AVINASH KAUR RANA |
| Designation |
LECTURER |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH |
| Address |
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872728461 |
| Fax |
|
| Email |
ranaavinash57@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KUMARI KHUSHBOO |
| Designation |
STUDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH |
| Address |
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
NATIONAL INSTITUTE OF NURSING EDUCATION,POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8303918123 |
| Fax |
|
| Email |
khushboobhu510@gmail.com |
|
|
Source of Monetary or Material Support
|
| KUMARI KHUSHBOO,
NATIONAL INSTITUTE OF NURSING EDUCATION,PGIMER,CHANDIGARH-160012,INDIA |
|
|
Primary Sponsor
|
| Name |
KUMARI KHUSHBOO |
| Address |
NATIONAL INSTITUTE OF NURSING EDUCATION,PGIMER,CHANDIGARH-160012 |
| 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 |
| kumari khushboo |
NEW OPD,PGIMER, Chandigarh |
ANC,NEW OPD
Chandigarh
CHANDIGARH |
8303918123
khushboobhu510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O132||Gestational [pregnancy-induced] hypertension without significant proteinuria, second trimester, pregnancy induced hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nursing interventional package
Routine care |
information about pregnancy induced hypertension,its causes,sign and symptoms,BP monitoring,diet, medicine adherence,exercises ,warning signs etc |
| Comparator Agent |
Routine care |
No treatment
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal mothers above 20 weeks of gestation diagnosed with PIH. |
|
| ExclusionCriteria |
| Details |
Antenatal mothers with any mental illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| maternal, fetal and neonatal outcomes |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal,fetal,neonatal outcomes |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2017 |
| Date of Study Completion (India) |
06/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Effectiveness of the "Nursing Interventional Package†on the management of pregnancy-induced hypertension for antenatal mothers, PGIMER, Chandigarh |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an experimental study to assess the effectiveness of nursing interventional package on management of pregnancy induced hypertension on selected maternal ,fetal and neonatal outcomes among antenatal mothers who are attending ANC, PGIMER,Chandigarh . |