| CTRI Number |
CTRI/2022/01/039454 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess pregnancy stress, fear and its associated factors during COVID-19 pandemic among antenatal women |
|
Scientific Title of Study
|
A study to asses fear of childbirth and its associated factors during COVID-19 pandemic among antenatal women in selected hospitals of Udupi district, Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dafinia Lamare |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Manipal College of Nursing, MAHE,Manipal |
| Address |
Manipal College of Nursing, Room No:604, 6th floor, Obstetric and Gynecology Nursing Department, MAHE, Manipal,
Udupi, Karnataka
-do-
Udupi
KARNATAKA
576104
India |
| Phone |
9615676800 |
| Fax |
|
| Email |
dafinia.lamare@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmitha Karkada |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Manipal College of Nursing, Room No:603-A, 6th floor, Obstetrics and Gynecology Nursing Department, MAHE, Manipal, Udupi, Karnataka
-do-
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sweety Jousline Fernandes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Manipal College of Nursing, Room No:603-A, 6th Floor, Obstetric and Gynecology Nursing Department, MAHE, Manipal, Udupi,Karnataka
-do-
Udupi
KARNATAKA
576104
India |
| Phone |
9945797188 |
| Fax |
|
| Email |
sweety.fernandes@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, MAHE, Manipal, Udupi-576104 |
|
|
Primary Sponsor
|
| Name |
Ms Dafinia Lamare |
| Address |
Manipal College of Nursing, MAHE, Manipal, Udupi-576104, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ms Dafinia Lamare |
Kasturba Hospital, Manipal |
Out patient department of Obstetric and Gynecology department, Antenatal wards, 3rd floor, 301, Kasturba Hospital, Manipal Udupi-576104
Udupi
KARNATAKA |
9615676800
dafinia.lamare@learner.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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women ≥19 years of age
Antenatal women who can read and write Kannada and English.
Antenatal women, including both primi gravida, multi gravida and grand multi gravida.
Antenatal women during their second and third trimester.
Antenatal women visiting antenatal OPD of Kasturba Hospital, Manipal.
Antenatal women admitted in antenatal ward of Kasturba Hospital, Manipal
|
|
| ExclusionCriteria |
| Details |
Antenatal women not willing to participate.
Antenatal mothers who have a history of mental health disorders or intake of psychiatric medications.
Current diagnosis of Covid-19.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess pregnancy stress, fear and associated factors during COVID-19 pandemic |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Find out the factors associated with pregnancy stress and fear during COVID-19 pandemic |
6 months |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
18/01/2022 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of the Study This study aims to assess pregnancy stress and fear of antenatal women in the midst of COVID-19 pandemic, to identify the associated factors affecting pregnancy and to inform the consultant obstetrician in case of severe fear for further assessment, treatment and referral. |