| CTRI Number |
CTRI/2024/11/076525 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [randomized control trial] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Post abortion self care package on selected outcome among Women had undergone abortion |
|
Scientific Title of Study
|
A Randomized control trial to assess the impact of Post abortion self care package on selected outcome among women had undergone abortion in Nehru hospital ,PGIMER, Chandigarh 2023-2024 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GarimaSharma |
| Designation |
M.Sc Nursing Student |
| Affiliation |
NINE,PGIMER,Chandigarh |
| Address |
Room No.202 ,Department Of Obstetrics and Gynecology ,NINE,PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
86280560062 |
| Fax |
|
| Email |
gs3982194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. V .Venkadalakshmi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education,PGIMER,Chandigarh |
| Address |
Room no.302,Department Of Obstetrics and Gynecology , National Institute of Nursing Education ,PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GarimaSharma |
| Designation |
M.sc nursing student |
| Affiliation |
NINE,PGIMER,Chandigarh |
| Address |
NINE,PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
86280560062 |
| Fax |
|
| Email |
gs3982194@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education ,PGIMER, Chandigarh, INDIA,PIN 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynecologynursing NINEPGIMERChandigarh |
| Address |
National Institute of Nursing Education, Post Graduate Institute Of Medical Science And Research , Chandigarh, Sector 12,PINCODE 160012,India |
| 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 |
| Dr VVenkadalakshmi |
Nehru Hospital ,Post Graduate Institute Of Medical Education And Research ,Chandigarh |
Department of Obstetrics and Gynecology Nursing, Division C, Septic labor room ward ,Room no:3001, Post Graduate Institute of Medical Science and Research , Chandigarh,
Chandigarh
CHANDIGARH |
9855552533
_v@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute Ethcs Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O030||Genital tract and pelvic infectionfollowing incomplete spontaneous abortion, (2) ICD-10 Condition: O038||Other and unspecified complications following complete or unspecified spontaneous abortion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients admitted in septic labor room Nehru hospital will be given routine care as per hospital policy |
As per hospital policy patient will be given routine care and no intermixing of group will be done and follow up will be taken after 4 weeks of routine hospital care |
| Intervention |
Post abortion self care package |
Demonstration on Post abortion Exercises, Perineal Care, Self Hygiene and dietary management for 2 weeks intervention follow up will be taken after 4 weeks of intervention and assess the effectiveness of package.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All women had undergone abortion either spontaneous and MTP in SLR, Gayne ward PGIMER ,Chandigarh
Women who are willing to participate in study.
Women who are able to understand Hindi ,English, Punjabi |
|
| ExclusionCriteria |
| Details |
Women with less than 18 year of age will not be included
Those who are not willing to participate in the study and does not know Hindi English and Punjabi |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
For experimental group post abortal self care package will be given and the variables will be seen are
Self- Care
Physical Outcomes
Psychological Outcomes
Use of contraception |
Intervention is for 2 weeks as per hospital policy daily intervention is given to women for next 4 weeks follow up . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevention of complication
Adherence to medication and follow-up |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2024 |
| 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
|
Post abortion women needs to care self to prevent further complications so need to focus on rest and sleep, adherence to medication ,exercises and check amount of bleeding ,level of Hb and regular follow so i use self care package to prevent post abortion complications. Hypothesis: There will be no significant effect of self care package on selected outcome variables at 0.05 level of significance. Alternate hypothesis : There will be significance effect of post abortion self acre package on selected outcome variable at 0.05 level of significance |