| CTRI Number |
CTRI/2019/07/020027 [Registered on: 04/07/2019] Trial Registered Prospectively |
| Last Modified On: |
03/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
information package for high risk mothers |
|
Scientific Title of Study
|
A preexperimental study to assess the effectiveness of “ information package for antenatal care"on maternal and fetal outcome among high risk mothers attending ANC PGIMER Chandigarh 2018-2020 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAMTA |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
N I N E PGIMER CHANDIGARH |
| Address |
ANC OPD PGIMER Chandigarh
ANC OPD PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560736514 |
| Fax |
|
| Email |
Chaudharymamta585@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drsukhjit kaur |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education |
| Address |
National institute of nursing education PGIMER Chandigarh
National Institute of Nursing Education PGIMER Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914536469 |
| Fax |
|
| Email |
drsukhjitkaur13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
National institute of nursing education PGIMER Chandigarh
National Institute of Nursing Education PGIMER Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560736514 |
| Fax |
|
| Email |
Chaudharymamta585@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER sector 12 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 |
| Mamta |
Nehru hospital PGIMER Chandigarh |
Antenatal OPD PGIMER sector 12 Chandigarh
Chandigarh
CHANDIGARH |
9560736514
Chaudharymamta585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Information package for antenatal care |
Total duration of therapy is 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women with high risk pregnancy |
|
| ExclusionCriteria |
| Details |
Antenatal women who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Normal Vaginal delivery |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healthy newborn |
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/08/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Article will be published in good peer journal review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| A preexperimental study to assess the effectiveness of “ information package for antenatal care†on maternal and fetal outcome among high risk mothers. High risk mothers will be enrolled and information package will be given to improve the maternal and fetal outcome. | |
|