| CTRI Number |
CTRI/2020/06/025616 [Registered on: 04/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NURSING ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Assess Effectiveness of a "Nurse initiated intervention" on reducing the postnatal complications. |
|
Scientific Title of Study
|
An Experimental study to assess the effectiveness of “Nurse initiated
interventional package based on health beyond pregnancy†on
selected outcome variables among postnatal mothers admitted in
Obstetrics and Gynecology department of Nehru Hospital, PGIMER,
Chandigarh 2019-2021. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Kumari |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research,Chandigarh. |
| Address |
Room.No.208 National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847526295 |
| Fax |
|
| Email |
nk449299@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Monaliza Mittal |
| Designation |
Lecturer |
| Affiliation |
Post Graduate Institute Of Medical Education And Research, Chandigarh. |
| Address |
Room.No.313 National Institute Of Nursing Education, Post Graduate Institute Of Medical Education And Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914477603 |
| Fax |
|
| Email |
monaliza.mittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Kumari |
| Designation |
M.Sc.Nursing Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research,Chandigarh. |
| Address |
Room.No.208 National Institute Of Nursing Education, Post Graduate Institute Of Medical Education And Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847526295 |
| Fax |
|
| Email |
nk449299@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| National Institute Of Nursing Education,Post Graduate Institute Of Nursing Education, Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute Of Nursing Education |
| Address |
Post Graduate Institute Of Medical Education And Research, Chandigarh. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Neha kumari |
Post Graduate Institute Of Medical Education And Research |
Clean labor room, Clean labor room extension, Maternity ward, Gynecology ward, Obstetrics And Gynecology Department, Nehru Hospital, PGIMER, Chandigarh.
Chandigarh
CHANDIGARH |
8847526295
nk449299@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROUTINE CARE |
ROUTINE CARE |
| Intervention |
SELF CARE BOOKLET FOR ANTENATAL WOMEN BASED ON HEALTH BEYOND PREGNANCY. |
It refers to the booklet on self-care
during postnatal period for women undergoing normal vaginal delivery; regarding
care of episiotomy, importance of exclusive breast feeding practice, prevention of
postnatal complications like postpartum haemorrhage, puerperal sepsis, wound
dehiscence and use of contraception during 6 weeks of postnatal period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal mothers:-
undergoing normal
vaginal delivery
willing to participate in
the study. |
|
| ExclusionCriteria |
| Details |
exclusion criteria:-
Antenatal mothers
with deficits in higher
mental functions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It includes the variables that will be assessed during
postnatal period
Healing of episiotomy,
Exclusive breast feeding,
Absence of postnatal complications,
stability of vital signs,
Involution of uterus,
contraceptive method adopted,
Length of hospital stay.
|
daily observation and recording up till discharge and at the time of postnatal follow up after 6 week period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It includes the variables that will be assessed during
postnatal period
Healing of episiotomy,
Exclusive breast feeding,
Absence of postnatal complications,
stability of vital signs,
Involution of uterus,
contraceptive method adopted,
Length of hospital stay.
|
daily observation and recording up till discharge and at the time of postnatal follow up after 6 week period |
|
|
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 1 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| 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)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
have submitted for the publication as an original research article under IJRMS. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The nurse initiated interventional packages are very beneficial for the postpartum women. Although women and their newborns have the provision for routine postnatal care ,several important factors and conclusions of recent studies raise the concern on the quality and effectiveness of postnatal care provided. The nurse initiated interventional package helps women in gaining confidence and thus making her self-reliant to reduce postnatal complications. Empowering her enough to let her make a choice for adoption of early contraceptive method. The main outline focuses upon the early identification of symptoms of infection, prevention of PPH, healing of episiotomy, exclusive breast feeding, reducing chances of wound dehiscence, subinvolution and decreasing the length of hospital stay. OBJECTIVES:- To develop and implement Nurse initiated interventional package based on health beyond pregnancy among postnatal mothers in Obstetrics and Gynecology department of Nehru Hospital, PGIMER, Chandigarh. To evaluate the effectiveness of Nurse initiated interventional package on selected outcome variables among postnatal mothers in Obstetrics and Gynecology department of Nehru Hospital, PGIMER, Chandigarh. The nurse led interventional package in the form of booklet will be effective in reducing postnatal complications. |