| CTRI Number |
CTRI/2024/08/072587 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Study to improve the Respectful maternity care by doing with Focused group discussion and its outcome in perinatal mothers. |
|
Scientific Title of Study
|
A Quality improvement study to improve theRespectful maternity care and its outcome in perinatal mothers admitted in selected obstetrics unit of Nehru Hospital, PGIMER, Chandigarh 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Nigam |
| Designation |
M.Sc. Nursing |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute Of Nursing Education, PGIMER, Chandigarh
Department of Nursing, Room no-201
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7525971498 |
| Fax |
|
| Email |
Aarti18.dec@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. V. Venkadalakshmi |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute Of Nursing Education, PGIMER, Chandigarh, Room no-201
National Institute Of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Nigam |
| Designation |
M.Sc. Nursing |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute Of Nursing Education, Room no-201 PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7525971498 |
| Fax |
|
| Email |
Aarti18.dec@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aarti Nigam |
| Address |
Department of Nursing, NINE, PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Aarti Nigam |
Nehru hospital |
Department of Obstetrics and Gynecology, PGIMER Chandigarh
Chandigarh
CHANDIGARH |
7525971498
Aarti18.dec@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
QI to improve RMC |
QI to improve RMC in perinatal mothers for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Perinatal mothers admitted in Selected Obstretics unit |
|
| ExclusionCriteria |
| Details |
Mothers who are elective LSCS are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Physical abuse
2. Non- consented care
3. Non- dignified care
4. Care denial
5. Discrimination
6. Detension in facilities
|
3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal satisfaction
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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="0"
Months="3"
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
|
Respectful Maternity care is the basic right for all pregnant women. Globally intrapartum mistreatment is reported which includes shouting, slapping, pinching, hitting and application of extreme fundal pressure. There is a national wide need to focus on the quality of care provided to the mothers during Intranatal, Antenatal and Postnatal period to improve the Experience of mother. With the QI approach it is possible to assess the barriers in providing the RMC and through Focused group discussion it can be assess and measures will be taken to improve it. |