| CTRI Number |
CTRI/2022/11/047235 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CHECKING OR UNDERSTANDING THE KNOWLEDGE, AND PRECTICE AMONG THE PREGNANT WOMEN ABOUT NUTRITON AND DRUGS TAKEN DURING THE PREGNANCY |
|
Scientific Title of Study
|
ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE AMONG PREGNANT WOMEN REGARDING NUTRITIONAL REQUIREMENTS AND DRUGS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GAUTHAMI R |
| Designation |
Student |
| Affiliation |
NGSM institute of pharmaceutical science |
| Address |
Department of Pharmacy Practice,
NGSM institute of pharmaceutical science
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363291371 |
| Fax |
|
| Email |
rgauthami25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
NGSM institute of pharmaceutical science
Paneer, Derlakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnapriya R |
| Designation |
Associate Professor |
| Affiliation |
Justice K S Hegde Charitable Hospital |
| Address |
Department of OBG
K.S Hegde Medical Academy
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9008416076 |
| Fax |
|
| Email |
kpriya252003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PHARMACY PRACTICE, NGSM INSTITUTE OF PHARMACIEUTICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Gauthami R |
Justice K S Hegde Charitable Hopsital |
department of obstectrics and gynaecology
Dakshina Kannada
KARNATAKA |
6363291371
rgauthami25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in their first, second and third trimester who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Pregnant women who refused to participate in the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess knowledge, attitude and practice regarding nutrition and drugs among pregnant women |
single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate prescribing patterns and categorize according to FDA |
single point |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
16/11/2022 |
| 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="8"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE AMONG
PREGNANT WOMEN REGARDING NUTRITIONAL REQUIREMENTS AND DRUGS
INTRODUCTION:
Pregnancy is a dynamic change in a woman requiring excessive
care as the nourishment of the foetus is directly through the placenta of the
mother. Nutrition plays a pivotal role in pregnancy. Prescribing drugs in
pregnancy is a challenge to a physician mainly because of the possibility of
teratogenicity with medicines which it is inevitable.
OBJECTIVES OF THE STUDY:
To assess knowledge, attitudes and practices on nutrition
and drug among pregnant women and to evaluate prescribing patterns and categorize
according to the FDA
JUSTIFICATION FOR THE STUDY:
Assessment of pregnant women’s knowledge, attitudes and
practices on nutrition and drug is important. This evaluation will bring out
the facts regarding the consumption of nutritious food and use of medications
during pregnancy.Evaluation of drug prescriptions in pregnancy is vital. This
will give information regarding the patterns of drug use in pregnancy for
various conditions. Moreover, the adherence to the prescribed drugs can be
identified. The study will also categorize the prescribed drugs and also non
prescribed drugs that was used and reported by the participants as per the FDA.
This study helps to know the mother’s point of view towards the nutrition and
the drugs
METHODOLOGY:
A prospective cross sectional study will be conducted for a
duration of 8 months among the pregnant women of all three trimesters presenting
to OPD and admitted in the obstetrics and gynaecology department. Details will
be collected in a suitably designed data collection form. KAP questionnaire is developed
by referring to various primary, secondary and tertiary resources of
information then administered to the participants.
STATISTICAL ANALYSIS: Sample size is 264. Data will be
summarized using descriptive statistics.
ANTICIPATED OUTCOMES:
This study will help to determine knowledge, attitude and
practice on nutrition and drug in pregnant women. Food habits of the pregnant
adolescents are obtained. Percentage of drugs prescribed from FDA pregnancy
drug risk category and their documentation. Adherence to the prescribed drugs
and reason for non adherence can be identified. Overall mothers point of view
towards the nutrition and the drug intake will be acquired.
|