| CTRI Number |
CTRI/2020/12/029955 [Registered on: 21/12/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the COVID-19 on services offered to pregnant women and their mental health in urban areas of Hyderabad- A study |
|
Scientific Title of Study
|
Effect of the pandemic on maternal health services and mental health of pregnant women in urban areas of Hyderabad- A cross sectional study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhamshi Beeram |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Pubic Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9611396236 |
| Fax |
|
| Email |
beeram.sudhamshi1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi Rao |
| Designation |
Coordinator, MPH Programme |
| Affiliation |
Prasanna School of Pubic Health |
| Address |
Room number 60, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104.
Udupi
KARNATAKA
576104
India |
| Phone |
08202923111 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhamshi Beeram |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Pubic Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104.
KARNATAKA
576104
India |
| Phone |
9611396236 |
| Fax |
|
| Email |
beeram.sudhamshi1@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health, MAHE |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health MAHE |
| Address |
Room number 63, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104. |
| Type of Sponsor |
Other [Private institution of education and research] |
|
|
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 Sumit Kumar |
Prasanna School of Public Health |
LH- 63, First Floor, Prasanna School of Public Health, Manipal
Udupi
KARNATAKA |
8867620088
kumar.sumit@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women who have been diagnosed as pregnant on or before August 1st, 2020. |
|
| ExclusionCriteria |
| Details |
Postpartum women and women who underwent an abortion are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of the pandemic on maternal health services and mental health of pregnant women. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To consider the results and design future interventions for continuum of maternal health care services and safeguarding the mental health of pregnant women in situations such as pandemics. |
6 months- 1 year |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
30/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/03/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a cross-sectional study to explore how pandemic affected maternal health services and the mental health of pregnant women. The study will be conducted in urban areas of Hyderabad on 300 pregnant women, diagnosed on or after August 1st, 2020. The primary outcome will be to study the effect of the pandemic on maternal health services and mental health on pregnant women in 3 months. The secondary outcome will be to consider these results and design future interventions for the continuum of maternal health care services and safeguarding the mental health of pregnant women in 6 months to 1 year. |