| CTRI Number |
CTRI/2025/07/090512 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quality improvement |
| Study Design |
Other |
|
Public Title of Study
|
A quality improvement study to improve postpartum care among post cesarean mothers |
|
Scientific Title of Study
|
A quality improvement study to improve postpartum care among post cesarean mothers admitted in Obstetric Units, Nehru Hospital, 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 |
Ms. Swati |
| Designation |
MSc nursing student |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, PGIMER Chandigarh (160012) India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8351975440 |
| Fax |
- |
| Email |
swati75440@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh |
| Address |
Room No. 211, Department of Nursing, National Institute of Nursing Education, PGIMER Chandigarh 160012) India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
- |
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Geetanjali Kalyan |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh |
| Address |
Room No. 223, Department of Nursing, National Institute of Nursing Education, PGIMER Chandigarh (160012) India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7696028309 |
| Fax |
- |
| Email |
geetss2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetric and gynecology, Block B , 3rd floor , Nehru Hospital, PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
Miss Swati |
| Address |
National Institute of Nursing Education, NINE , PGIMER |
| 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 sushma kumari saini |
Nehru hospital PGIMER |
PGIMER Chandigarh
Chandigarh
CHANDIGARH |
09888038248
-
sushmadrsaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O868||Other specified puerperal infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-Post C- section mothers - Healthcare providers willing to participate in study |
|
| ExclusionCriteria |
| Details |
critically ill mothers
-Hemodynamically unstable mothers
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to improve postpartum care among post cesarean mothers |
Baseline , 15 days ,1 month,1 month 15 days,2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
02/06/2026 |
| 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
|
A quality improvement study to improve postpartum care among post cesarean mothers admitted in Obstetric Units, Nehru Hospital, PGIMER, Chandigarh, 2024-26. The objective is to assess the current practices of postpartum care in obstetric units and implement postpartum care checklist to improve postpartum care.
|