| CTRI Number |
CTRI/2022/01/039688 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Experiences and perspectives of services during pregnancy among rural pregnant women during Covid-19. |
|
Scientific Title of Study
|
An exploratory study of perspectives and experiences of antenatal
care services among pregnant women during COVID-19 pandemic in rural areas of Billawar,
Kathua District, Jammu and Kashmir Union Territory |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aastha Radotra |
| Designation |
Post graduation student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Master of Public Health, Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, District Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6005312434 |
| Fax |
|
| Email |
aastha.radotra@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arathi Rao |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Master of Public Health, Prasanna School Of Public Health, Manipal Academy of Higher Education Madhav Nagar, Manipal, District Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aastha Radotra |
| Designation |
Post graduation student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Master of Public Health, Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, District Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6005312434 |
| Fax |
|
| Email |
aastha.radotra@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Policy, Prasanna School of Public Health, Madhav Nagar, Manipal Academy of Higher Education, District Udupi, Karnataka. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Suman Gupta |
Community Health Centre |
room no. 12, Gynaecology Department, Community Health Centre, Bilawar, Ditrict Kathua. Jammu and Kashmir
Kathua
JAMMU & KASHMIR |
9419182691
adfamilywelfarejammu@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who are enrolled in Community Health Centres will be recruited for the study.
|
|
| ExclusionCriteria |
| Details |
Pregnant women who are not willing to participate in the study will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Experiences and perspectives of pregnant women on antenatal care services. |
4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of gaps in the provision of antenatal care services. |
30th June 2022 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2022 |
| Date of Study Completion (India) |
29/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Antenatal care (ANC) is potentially one of the most effective
health interventions for preventing maternal morbidity and mortality, particularly in places
where the general health status of women is poor. The World Health Organization (WHO)
recommends a minimum of four ANC visits, comprising interventions such as tetanus toxoid
vaccination, iron, and folic acid supplementation, screening and treatment for infections, and
identification of warning signs during pregnancy. According to a report by UNICEF India (7th May 2020). India was projected to record the
highest number of births since COVID-19 was declared a pandemic in March 2020, with 20.1
million babies expected to be born between March and December. This gives us a rough
estimate that a large number of women are deprived of appropriate antenatal care during their
pregnancy. As the majority of health care delivery facilities are dedicated to COVID-19 care,
staff getting engaged in emergency COVID-19 duties, staff becoming COVID-19
positive, and mandatory quarantines of staff have restricted delivery of antenatal care. On the
demand side, lack of information about the availability of services increased fears and concerns
of being exposed, movement restrictions, loss of income, and social factors caused hindrance
in seeking continuous antenatal care services. There are studies that reflect the district-level disparities in the coverage of ANC services
in J&K in context to socioeconomic status. The overall coverage gap for ANC was
23.9%Pregnant
women especially those that live in rural areas of J&K usually have to cover long distances
and embark on difficult journeys to reach the maternity hospitals as the nearby hospital was
converted into COVID center. These long journeys are the ‘silent killer’ as the over-exertion
or injury caused by journeying on this road can lead to miscarriages. Inclusion criteria: Pregnant women who are enrolled in Community Health Centres
will be recruited for the study.
b) Exclusion criteria: Pregnant women who are not willing to participate in the study will
be excluded. Tools used: In-depth interview guide will be used for data collection. Statistical methods: MAXQDA software. |