| CTRI Number |
CTRI/2025/10/096589 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method Research Approach - Exploratory sequential |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and testing a postpartum assessment graph for first-time mothers used by healthcare providers |
|
Scientific Title of Study
|
Development, Validation and usability of Postpartum graph for postnatal Assessment among Primiparous women through healthcare providers in selected hospitals, Uttar Pradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Dean |
| Designation |
PHD Scholar |
| Affiliation |
College of Nursing, Teerthanker Mahaveer University |
| Address |
T.M College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8826282339 |
| Fax |
|
| Email |
monika.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Toshniwal |
| Designation |
Professor |
| Affiliation |
College of Nursing, TMU Moradabad (U.P.) |
| Address |
T.M College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8057000933 |
| Fax |
|
| Email |
Varun.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Toshniwal |
| Designation |
Professor |
| Affiliation |
College of Nursing, TMU Moradabad (U.P.) |
| Address |
T.M College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.)
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8057000933 |
| Fax |
|
| Email |
Varun.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| All Community Health Centers - Gautam Budh Nagar |
|
|
Primary Sponsor
|
| Name |
Monika Dean |
| Address |
College of Nursing, Teerthanker Mahadev University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.)-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 |
| Monika Dean |
Community Health Centers |
POST NATAL WARD/ OBSTETRICAL AND GYNAECOLOGICAL NURSING
Gautam Buddha Nagar
UTTAR PRADESH |
8826282339
monika.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Teerthanker Mahaveer Dental College & Research Centre, Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primiparous Post-Natal Mothers |
|
|
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 |
1. Primiparous postnatal women
2. After conducting normal delivery
3. Willing to participate |
|
| ExclusionCriteria |
| Details |
1. With pre-existing medical disorders
2. Multiparous women
3. After cesarean section |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development, validation, and usability testing of a postpartum assessment graph for postnatal evaluation among primiparous women through healthcare providers. |
Development, validation, and usability testing of a postpartum assessment graph for postnatal evaluation among primiparous women through healthcare providers. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
01/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to develop, validate, and assess the usability of a postpartum assessment graph for primiparous women. The primary purpose is to enhance structured postnatal care by introducing a user-friendly visual monitoring tool. The study uses a mixed-method design with three phases: development through literature review and Delphi technique, validation by experts, and usability testing by healthcare providers. The hypothesis is that the newly developed postpartum graph will be a valid and usable tool to support postnatal assessments in clinical settings. |