| CTRI Number |
CTRI/2024/04/066562 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Prescription Pattern in Pregnant Women |
|
Scientific Title of Study
|
A Descriptive Study of Prescription Pattern in Pregnant Women
attending Antenatal Clinic of Department of Obstetrics and
Gynaecology in SMS Medical College and Hospitals Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suchibrata De |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8697605025 |
| Fax |
|
| Email |
deysuchibrata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Bhargava |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Dr. Jyotsna Bhargava, Senior Professor, Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829506847 |
| Fax |
|
| Email |
drjyotsna2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsna Bhargava |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Dr. Jyotsna Bhargava, Senior Professor, Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829506847 |
| Fax |
|
| Email |
drjyotsna2003@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College, JLN Marg, Jaipur, Rajasthan, India (302004) |
|
|
Primary Sponsor
|
| Name |
Dr. Suchibrata De |
| Address |
Department of Pharmacology, SMS Medical College, JLN Marg, Jaipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Suchibrata De |
Zanana Hospital of SMS Hospital Jaipur |
Antenatal Outpatients Department of Obstetrics and Gynaecology, Zanana Hospital, Chand-Pole Gate, Station Rd, Reserve Police Line, Sindhi Camp, Jaipur, Rajasthan 302016
Jaipur
RAJASTHAN |
8697605025
deysuchibrata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee SMS Medical College and Attached Hospital Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant woman of age 18 years and above.
2. Pregnant women with Intrauterine pregnancy.
3. Pregnant woman who will give Informed Consent for the study |
|
| ExclusionCriteria |
| Details |
1. Pregnant women who will be in active labour.
2. Pregnant women with severe eclampsia, severe heart diseases, infectious diseases
and any emergency conditions.
3. Pregnant women who are part of any other study.
4. Pregnant women who will be non-co-operative. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study Prescription Pattern in pregnancy by WHO Core Prescribing indicators:
• Average number of drugs per encounter.
• Percentage of drugs prescribed by generic name.
• Percentage of encounters with an antibiotic prescribed.
• Percentage of encounters with an injection prescribed.
• Percentage of drugs prescribed from Essential Drugs List (EDL), Rajasthan.
(Recently updated in 2019) |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the Drug Compliance by using Modified Morisky Scale (MMS).
2. To assess the sociodemographic profile of patients under study.
|
6 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Continuous supervision of all medications prescribed among pregnant women is
necessary to monitor whether the potential benefits to mother overshadow the threat to
the foetus. Additive safety must be taken on the drug use in women who are or may
become pregnant specifically all the way through her first trimester.
Inadequate drug monitoring in pregnant women can lead to consequences such as
improper treatment, adverse effects, increased drug burden on pregnant woman. Some
drugs are recommended only in certain trimester.
This study on prescription pattern among pregnant women will be helpful in
understanding the prescription patterns of different drugs in pregnant women in different
trimesters and also helps in specific medicines options in pregnancy and also the need to
develop and implement systems to prevent exposures to drugs which are known to pose a
risk to the mother or foetus. |