| CTRI Number |
CTRI/2019/07/020298 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Supplement adherence kit for antenatal mothers |
|
Scientific Title of Study
|
A Quasi experimental Study to Assess the Effectiveness of ‘Supplement Adherence Kit’ on Intake of Nutritional Supplements Among Pregnant Women Attending ANC , New OPD, 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 |
Aditi Chaudhary |
| Designation |
Msc. Nursing Student |
| Affiliation |
PGIMER Chandigarh |
| Address |
House number 268
Phase 1 , Eco City , New Chandigarh
Mullanpur
Punjab
National Institute of Nursing Education
Sector 12 PGI Chd.
Chandigarh
CHANDIGARH
140901
India |
| Phone |
8528201806 |
| Fax |
|
| Email |
aditichaudhary167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monaliza |
| Designation |
Lecturer |
| Affiliation |
PGIMER Chandigarh |
| Address |
National Institute of Nursing Education
PGIMER, Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914477603 |
| Fax |
|
| Email |
monaliza.mittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi chaudhary |
| Designation |
Msc. Nursing Student |
| Affiliation |
PGIMER Chandigarh |
| Address |
House number 268
Phase 1 , Eco City , New Chandigarh
Mullanpur
Punjab
Chandigarh
CHANDIGARH
140901
India |
| Phone |
8528201806 |
| Fax |
|
| Email |
aditichaudhary167@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education ,PGIMER, Chandigarh PIN-160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of medical educational research |
| Address |
National institute of nursing education
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 |
| Aditi Chaudhary |
PGIMER, Chandigarh |
Antenatal clinic
Chandigarh
CHANDIGARH |
8528201806
aditichaudhary167@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 |
Antenatal mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Daily routine care will be given to mothers she will get Tab Iron OD, T Calcium BD , T Folic acid OD for 3 months daily |
| Intervention |
Supplement Adherence kit |
Kit containing calendar pen stick notes instruction booklet and reminder calls |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida mothers of second trimester attending ANC clinic, PGIMER Chandigarh.
Mothers who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Mothers with cognitive deficits |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Supplementation Adherence
Anemia (Hb level mg/dl)
Minor ailments (constipation,Heartburn,Pica)
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minor ailments |
6 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
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/07/2019 |
| 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="1"
Months="6"
Days="7" |
|
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
|
This study will help antenatal mothers to increase the compliance of supplements for better growth and development of fetus and for prevention of anaemia among pregnant women. As pregnant women require the supplements during pregnancy to meet the requirement of growing fetus |