| CTRI Number |
CTRI/2020/12/030127 [Registered on: 30/12/2020] Trial Registered Prospectively |
| Last Modified On: |
24/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Trends of maternal mortality during COVID -19 pandemic at our tertiary care institute. |
|
Scientific Title of Study
|
Direct and Indirect Impact of COVID-19 pandemic on maternal mortality. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAlka Sehgal |
| Designation |
Professor |
| Affiliation |
Government Medical College & Chandigarh |
| Address |
4th floor
D block
Deptt of Obstetrics & Gynecology
GMCH-32 Chandigarh,India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121579 |
| Fax |
|
| Email |
drasehgal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSunita Dubey |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College & Hospital,Sector-32,Chandigarh |
| Address |
4th Floor
D-Block
Office of Deptt of Obstetrics & Gynecology
GMCH-32B Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646323268 |
| Fax |
|
| Email |
sunitas504@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSunita Dubey |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College & Hospital,Sector-32,Chandigarh |
| Address |
4th Floor
D-Block
Office of Deptt of Obstetrics & Gynecology
GMCH-32B Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646323268 |
| Fax |
|
| Email |
sunitas504@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not required |
| Address |
Not required |
| Type of Sponsor |
Other [Not required] |
|
|
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 |
| DrMohit Satodiya |
GMCH -32,Chandigarh |
Department of Obstetrics and Gynecology,4th floor,D-Block,
GMCH Sector 32,Chandigarh
160030
Chandigarh
CHANDIGARH |
918146256434
mohitsatodia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMCH Institute ethical committee |
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, (2) 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 |
45.00 Year(s) |
| Gender |
Female |
| Details |
All Maternal deaths that occurred at our institute during pregnancy or within 42 days of pregnancy termination as a result of pregnancy, childbirth, and the puerperium related complications and in-transit deaths in ambulance/any recognized patient transport system with reliable history & documentation of pregnancy related complications in the referral slip and confirmed at our institute after assessment of deceased will also be included. |
|
| ExclusionCriteria |
| Details |
All accidental deaths like Suicide, poisoning, Snake bite, hanging, burns and road side accident will be excluded from the study.
Maternal mortality due to COVID -19 infection will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze trends of maternal deaths during COVID -19 pandemic and to compare it with those occurred before COVID - 19 pandemic at our tertiary care institute. Any changes in Demographic parameters of both the groups . |
Maternal mortality that occurred within 6 month before COVID-19 pandemic will be compared with (Group B) maternal mortality that happened within 6 month after declaration of lockdown in India. Maternal mortality data of year 2019 will also be analyzed to know maternal mortality ratio at our institute before COVID-19 pandemic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Impact of COVID-19 on obstetric transition.
2.Impact on Institutional delivery
3.Change in stillbirth rate |
Within 6 month before and 6 month after lockdown due to COVID-19 pandemic. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Material and methods:
This will be a retrospective cohort study which will be conducted in the
Department of Obstetrics and Gynecology at Government Medical College Hospital,
Chandigarh after Clearance from research and Ethical Committee. Data of
maternal mortality will be collected from the facility based maternal mortality review
proformas for 6 month duration before the announcement of lock down in
India from Ist October,2019
to 31st March,2020 and will be compared to 6 month data of maternal
mortality which occurred after lockdown from
Ist April, 2020 to 30th September, 2020. Thus,
study population will be divided into two groups according to the anouncement of
lockdown in India: before COVID-19 pandemic (Group A) and after lockdown (Group
B).
Analysis of maternal
mortality data of year 2019 will also be done to know maternal mortality ratio at
our institute for comparison with data after announcement of lockdown. Primary
objective of the study are to analyze trends of maternal deaths during COVID
-19 pandemic and to compare it with those occurred before COVID - 19 pandemic
at our tertiary care institute. Demographic parameters of both the groups will also considered.
Statistical analysis: Discrete categorical data will be presented as n (%); continuous
data were given as mean ± SD and range. Proportions will be compared between the
groups using the chi-square test. All statistical tests will be performed at a
significance level of α=0.05. Analysis will be conducted using IBM SPSS STATISTICS
(version 22.0).
|