| CTRI Number |
CTRI/2019/07/019983 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
01/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Health promotion interventions for perinatal mothers |
|
Scientific Title of Study
|
Quasi experimental study to assess the effectiveness of health promotion interventions on selected perinatal outcome among mothers admitted for elective caesarean in PGIMER, Chandigarh, 2018-20 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveena Kumari |
| Designation |
Student |
| Affiliation |
PGIMER Chandigarh |
| Address |
National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9816111390 |
| Fax |
|
| Email |
praveenakumari195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VVenkadalakshmi |
| Designation |
Lecturer |
| Affiliation |
PGIMER Chandigarh |
| Address |
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 |
Praveena Kumari |
| Designation |
Student |
| Affiliation |
PGIMER Chandigarh |
| Address |
National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9816111390 |
| Fax |
|
| Email |
praveenakumari195@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education PGIMER, Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research |
| Address |
National institute of nursing education PGIMER Chandigarh. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Praveena Kumari |
Obstetrics and Gynaecological Department |
Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
09816111390
praveenakumari195@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 |
| Healthy Human Volunteers |
mothers during antenatal and postnatal period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group will recieve the routine care including vital sign monitoring, pain management , control of infection and care of newborn |
Control group will recieve the routine care including vital sign monitoring, pain management , control of infection and care of newborn |
| Intervention |
Health Promotion Interventions |
It is an Interventional Package which containing education, videos and demonstrations to the mothers regarding care of self and her baby after elective caesarean section and these interventions are given the interventional group and control group will get the interventions after study
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Mothers with ≥ 32 weeks of gestation, admitted for elective caesarean in PGIMER, Chandigarh.
Mothers who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
Mothers who are mentally unhealthy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| interventions will reduce the complications after caesarean section and they will also develop skills in mothers for newborn care and in postnatal adjustment. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mothers will be healthy and will have n complications |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/07/2019 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In the present study we will develop a protocol which includes interventions for the promotion of health of postnatal mothers after elective caesarean section and these interventions will help the mothers to independently care to self and baby. The study will be published in an authorized journal. |