| CTRI Number |
CTRI/2015/04/005730 [Registered on: 29/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
29/04/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of the health and nutrtional status of pregnant women & nutrtional education |
|
Scientific Title of Study
|
To Assess the Health and Nutritional status of Pregnant Women and to impart Nutritional Education (20 to 45 years) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasundhara Agarwal |
| Designation |
student |
| Affiliation |
Dr. B.M.N College of Home Science |
| Address |
DR. B.M.N College of Home Science
338, R A Kidwai Road, Matunga, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9930609049 |
| Fax |
|
| Email |
vasuagrawal@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Battalwar |
| Designation |
Guide |
| Affiliation |
Dr. B.M.N College of Home Science |
| Address |
Sir Vithaldas Vidyavihar, Juhu Tara Road, Santacruz West
DR. B.M.N College of Home Science
338, R A Kidwai Road, Matunga, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9930609049 |
| Fax |
|
| Email |
drrekhab12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara Agarwal |
| Designation |
student |
| Affiliation |
Dr. B.M.N College of Home Science |
| Address |
DR. B.M.N College of Home Science
338, R A Kidwai Road, Matunga, Mumbai
MAHARASHTRA
400019
India |
| Phone |
9930609049 |
| Fax |
|
| Email |
vasuagrawal@icloud.com |
|
|
Source of Monetary or Material Support
|
| Enclave MAternity Home
Building no 54, Yashodham Enclave, Film City Road, Goregaon East, Mumbai- 400063 |
|
|
Primary Sponsor
|
| Name |
Nandkishore Agrawal |
| Address |
402, Tulip, Vasant Valley complex, Nr Dindoshi, Malad (east) Mumbai - 400097 |
| Type of Sponsor |
Other [Monetary] |
|
|
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 Rekha Agrawal |
Ark clinic |
Gulmohar colony, Juhu road, Mumbai- 400058
Mumbai (Suburban)
MAHARASHTRA |
02226050707
vaagrawal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ark hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Women in their 2nd Trimester |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in their 2nd trimester |
|
| ExclusionCriteria |
| Details |
1st & 2nd trimester, In Vitro Fertilization. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The trend of pregnancy in India and how nutrtion plays an imporanat role |
January 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant weight gain in 2nd trimester |
increase in weight in kgs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess the nutrient intake of pregnant women, their anthroometric measurements and to impart nutritional education. Basically to study the trend of pregnancy in India and how nutrition plays an important role in pregnancy.
Null Hypothesis: There is no adverse effect of nutrition on pregnancy. |