| CTRI Number |
CTRI/2021/09/036831 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How much does the diabetes increase the severity of COVID -19 infection in pregnancy compared to people without Diabetes ? |
|
Scientific Title of Study
|
Does Diabetes alter the severity of COVID-19 infection in Pregnancy ? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simi Kurian |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Kannur,kerala |
| Address |
Room 405 , fourth floor
Department of Obstetrics and Gynecology
Government Medical College ,Kannur,Pariyaram
Kerala
Kannur
KERALA
670503
India |
| Phone |
8156991384 |
| Fax |
|
| Email |
drsimikurian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simi Kurian |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Kannur,kerala |
| Address |
Room 405 , fourth floor
Department of Obstetrics and Gynecology
Government Medical College ,Kannur,Pariyaram
Kerala
Kannur
KERALA
670503
India |
| Phone |
8156991384 |
| Fax |
|
| Email |
drsimikurian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simi Kurian |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Kannur,kerala |
| Address |
Room 405 , fourth floor
Department of Obstetrics and Gynecology
Government Medical College ,Kannur,Pariyaram
Kerala
Kannur
KERALA
670503
India |
| Phone |
8156991384 |
| Fax |
|
| Email |
drsimikurian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kannur,Pariyaram,Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Simi Kurian |
| Address |
Room 405 , fourth floor ,Department of OBG
Government Medical College Kannur,Pariyaram ,Kerala |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manu Mathews |
Room 406 ,fourth floor , Dept of Medicine , Govt Medical College Kannur ,Pariyaram , Kerala PIN 670503 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simi Kurian |
Government Medical College,. Kannur , Pariyaram , kerala |
fourth floor , Dept of OBG, Pariyaram, Kannur District , Kerala, PIN 670503
Kannur
KERALA |
8156991384
drsimikurian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Govt Medical College,Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients admitted to the study centre with pregnancy and lab-confirmed COVID -19 infection during the study period |
|
| ExclusionCriteria |
| Details |
patients transferred to other centres or discharged against medical advice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the risk of severe infection with COVID-19 in pregnancy in patients with Diabetes compared to those without Diabetes |
1 year (from August 1 ,2020 to July 31,2021) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the maternal and fetal outcomes of diabetes in pregnancy with COVID-19 infection |
1 year ( Aug 1,2020 to July 31 2021) |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
04/10/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Observational study to determine the risk for severe infection with COVID-19 in pregnancy to those with Diabetes compared to those without Diabetes. Pregnant patients with COVID-19 infection who presented in our study centre during the study period were divided into those with severe infection ( patients with respiratory distress and spo2 < 94%) and nonsevere infection . Patients with diabetes in study group were identified .Crude and adjusted prevalence odds ratio of diabetes causing severe infection will be statistically determined. Also the maternal and fetal outcome in study group will be analysed and discussed . |