| CTRI Number |
CTRI/2025/05/087801 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Effect of a Nursing Intervention Package on Liver-Related Pregnancy Problems Among Antenatal Women Attending ANC OPD at PGIMER, Chandigarh (2024–2026) |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effect of nursing interventional package on liver problems related to pregnancy on the selected outcome variables among antenatal women attending ANC, OPD, PGIMER, Chandigarh, 2024-26. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani |
| Designation |
MSC Nursing student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh (Pin Code- 160012) India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9464675560 |
| Fax |
- |
| Email |
sainishivani973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Shruti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh PGIMER, Chandigarh |
| Address |
Room no:135, National Institute of Nursing Education, PGIMER, Chandigarh ( Pin code- 160012) India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
- |
| Email |
shruti2011pgi@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Shruti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no: 135, National Institute of Nursing Education, PGIMER, Chandigarh (Pin Code- 160012),India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
- |
| Email |
shruti2011pgi@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shivani |
| Address |
NINE PGIMER, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mrs Shruti |
New Obstetrics and Gynecology OPD, PGIMER, Chandigarh |
Department of Obstetrics and Gynecology, Room no: 2032, 2nd Floor
Chandigarh
CHANDIGARH |
08437748011
-
shruti2011pgi@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee ( Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O281||Abnormal biochemical finding on antenatal screening of mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nursing Interventional Package |
Effect of nursing interventional package on liver problems related to pregnancy. |
| Comparator Agent |
Routine Care |
Routine care will be provided only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal women with liver problems |
|
| ExclusionCriteria |
| Details |
Critically ill antenatal women with liver problems |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre term birth |
28 weeks
28-32 weeks
33-37 weeks
38 weeks till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/07/2025 |
| 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="1"
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 an interventional study to see the effect of nursing interventional package on liver problems related to pregnancy on the selected outcome variables among antenatal women attending ANC, OPD, PGIMER, Chandigarh, 2024-2026. The selected outcome variables will be maternal and neonatal outcomes. |