| CTRI Number |
CTRI/2022/02/040367 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
16/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of substance use and their effects in pregnancy |
|
Scientific Title of Study
|
Prevalence of substance use during pregnancy amongst women delivering in a tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr divya |
| Designation |
Post graduate student |
| Affiliation |
Maulana azad medical college |
| Address |
Room number 56 new nurses hostel MAMC DELHI
Department of obstetrics and gynaecology Maulana Azad medical college and Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9990971561 |
| Fax |
|
| Email |
obgy.divya.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MADHAVI M GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
Maulana azad medical college |
| Address |
Department of obstetrics and gynaecology Maulana Azad medical college and Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9711170960 |
| Fax |
|
| Email |
drmadhavimg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr divya |
| Designation |
Post graduate student |
| Affiliation |
Maulana azad medical college |
| Address |
ROOM NUMBER 56 NEW NURSES HOSTEL Department of obstetrics and gynaecology Maulana Azad medical college and Lok Nayak hospital
New Delhi
DELHI
110002
India |
| Phone |
9990971561 |
| Fax |
|
| Email |
obgy.divya.2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology Lok Nayak hospital |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college and Lok Nayak hospital |
| Address |
Department of obstetrics and gynaecology Lok Nayak hospital Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 divya |
LOK NAYAK HOSPITAL , MAULANA AZAD MEDICAL COLLEGE , NEW DELHI . |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY LOK NAYAK HOSPITAL DELHI
New Delhi
DELHI |
9990971561
obgy.divya.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y999||Unspecified external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all delivered patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of substance use amongst women delivering in a tertiary care centre centre |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maternal and fetal effects association in women using substance |
1 year |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
18/02/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
in this first we will see the prevalence of substance use during antenatal period . If we find positive patients then we will see its effects on baby and mother if anything significant present |