| CTRI Number |
CTRI/2018/04/013526 [Registered on: 27/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to see the effect of anaesthesia complications on mother and child health post cesarean section. |
|
Scientific Title of Study
|
A prospective observational study of Caesarean sections in tertiary care hospital for maternal and foetal outcome after anaesthesia related complications in obstetric operation theater. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/244/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogita Patil |
| Designation |
Associate Professor |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
Department of Anesthesia Seth GSMC and KEM hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Patil |
| Designation |
Associate Professor |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
Department of Anesthesia Seth GSMC and KEM hospital Parel Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunal Borkar |
| Designation |
Resident doctor |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
Department of Anesthesia Seth GSMC and KEM hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
vicky192.kb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS medical college and KEM hospital Parel Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth GS medical college and Kem hospital |
| Address |
Parel Mumbai 400012 |
| 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 Yogita Patil |
Seth GSMC and KEM hospital |
Department of anaesthesia old building first floor kem hospital
Mumbai
MAHARASHTRA |
9833935747
yogitapatil76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Seth GSMC Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
female patients to be taken for cessarean section either elective or emergency., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
all pregnant females to be taken for elective or emergency cessarean section in obstetric operation theater |
|
| ExclusionCriteria |
| Details |
patients not giving consent for the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of anaesthesia related complications and its effect on maternal and Fetal outcome |
After the completion of study and statistical analysis of the results. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To differentiate between anesthesia related complications of general and regional anaesthesia |
Upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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)
|
01/07/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Trial under recruitment phase |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a prospective observational study of maternal and fetal outcome after anaesthesia related complications in Caesarean sections to find out the incidence of anesthesia related complications it’s effect on maternal and fetal health and to differntiate the general and regional anesthesia complications. |